Ich

ICH
The term ICH is international conference hormonisation of technical requirements for registration of
pharmaceuticals for human use.
The name of ICH has now become more associated with the process of hormonisation, than the actual
conferences The ICH project is unique and since 1991 it has brought together by Drug Regulatory
Authorities and experts from the pharmaceutical industry in USA, European union and Japan to develop
agreement on core documentation, technical requirements and dossier for registration of new drugs.
The vast majority of new drugs and medicines are developed in Western Europe, Japan and USA and
therefore when ICH was established, it was agreed that its scope would be confined to registration in these
three regions.
The ICH was born in 1990 .The first ICH was held from 5-7 November 1991 at Brussels.
MEMBERS OF ICH:
1) ICH is a joint initiative involving both regulations and industry as equal partners. There are six parties
directly involved representing the regulation bodies and the research based industry associations in each
region. The parties involved from the European Union, Japan and USA are:
i) European Commission
ii) European Federation of Pharmaceutical Industries Associations.
iii) Ministry of Health and Welfare
iv) Japan Pharmaceutical Manufacturers Association
v) US Food and Drug Administration
vi) Pharmaceutical Research and Manufacturers of America
Each of the six co-sponsors has two seats on the ICH steering committee which oversees the harmonization
activities.
2) There are three observers:
i) World Health Organization
ii) European Free Trade Area (EFTA) represented at ICH by Switzerland and Canada.
iii) EFTA represented at ICH by the drugs Directorate Health Canada.
Each of the observer parties has a seat on the ICH steering committee.
3)The International Federation of Pharmaceutical Manufacturers Association(IFPMA) which is a federation
of member associations representing the research based pharmaceutical industry and other manufacturers of
prescription medicines in 56 countries has been closely associated IFPMA has two seats on the ICH
steering committee as non-voting members.
4) For smooth running of ICH, each of six co-sponsors designate an ICH coordinator to act as the main
contact point with the ICH secretariat and ensure that ICH documents are distributed to the appropriate
persons within the area of their responsibilities.
5)Each party has also established a contact network of experts with in their own organization (or)region in
order to ensure that they reflect the views and policies of the co sponsor they represent the way in which
this network operates differs according to administrative structure of the party concerned.
SCHEDULE OF MEETINGS:
ICH meeting have been held every alternate year .These have takenplace in 1991,1993,1995,1997 and the
last one was held in November 2000 at San Diego in USA.
ACTIVITIES OF ICH:
The first phase of ICH (1991-1997):-
The fourth international conference on Harmonisation, Brussels, 16-18 July 1997, marked the completion
of first phase of activities.
The development of Guidelines:-

In the first phase the exercise was directed towards the elimination of redundant and duplicates technical
requirements for registration in individual countries and lying down of minimum standards applicable
uniformly irrespective of where the product is manufactured and /or marketed.
This was successfully done with the development of over 40 guidelines covering efficacy, quality and
safety aspects of drug development.
Second phase of ICH (1998 to current):-
The ICH steering committee at a meeting held near Washington DC,2-5 February 1998 marked the start of
second phase of activities.
World Health Organization
WHO is the directing and coordinating authority for health within the United Nations system. It is
responsible for providing leadership on global health matters, shaping the health research agenda, setting
norms and standards, articulating evidence based policy options, providing technical support to countries
and monitoring and assessing health trends. In the 21st century, health is a shared responsibility, involving
equitable assess to essential care and collective defense against transitional threats.
Agenda. WHO operates in an increasingly complex and rapidly changing landscape. The boundaries of
public health action have become blurred, extending in other sectors that influence health opportunities and
outcomes. Who responds to these challenges using a six points address two health objectives, two strategic
needs and two operational approaches. The overall performance of WHO will be measured by the impact of
its work on women’s health and health in Africa.
1. Promoting development
During the past decade, health has achieved unprecedented prominence as a key driver of socioeconomic
progress and more resources than ever are being invested in health, yet poverty continues to contribute to
poor health, and poor health anchors large populations in poverty. Health development is directed by the
ethical principle of equity: access to life-saving or health promoting interventions should not be denied for
unfair reasons, including those with economic or social roots. Commitment to this principle ensures that
WHO activities aimed at health development give priority to health outcomes in poor, disadvantaged or
vulnerable groups. Attainment of the health-related Millennium Development Goals, Preventing and
treating chronic diseases and addressing the neglected tropical diseases are the cornerstones of the health
and development agenda.
2. Fostering health security
Shared vulnerability to health security threats demands collective action. One of the greatest threats to
international health security arises from outbreaks of emerging and epidemic –prone diseases. Such
outbreaks are occurring in increasing numbers, fuelled by such factors as rapid urbanization, environmental
mismanagement , the way food s produced and traded, and the way food is produced and traded, and the
way antibiotics are used and misused. The world’s ability to defend itself collectively against outbreaks has
been strengthened since June 2007, when the revised Internationational Health Regulations came into
force.
3. Strengthening Health systems
For health improvement to operate as a poverty-reduction strategy, health service must poor and
underserved populations. Health systems in many parts of the world are unable to do so, making the
strengthening of health systems a high priority for WHO. Areas being addressed include the provision of
adequate numbers of appropriately trained staff, sufficient financing, financing, suitable systems for
collecting vital statistics, and access to appropriate technology including essential drugs.
4. Harnessing health systems
Evidence provides the formulation for setting priorities, defining strategies, and measuring results. WHO
generates authoritative health information, in consultation with leading experts, to set norms and standards,
articulate evidence-based policy options and monitor the global health situation.
5. Enhancing partnerships

WHO carries out its work with the support and collaboration of many partners, UN agencies and other
international organizations, donors, civil society and the private sector. WHO uses the strategic power of
evidence to encourage partners to align their activities with best technical guidelines and practices, as well
as with the priorities established by countries.
6. Improving performance
WHO participates in ongoing reforms aimed at improving its efficiency and effectiveness, both at the
international level and within countries. WHO aims to ensure that its strongest asset – ots staff – works in
an environment that is motivating and rewarding. WHO plans its budget and activities through results-based
management, with clear expected results to measure performance at country regional and
international levels.
The role of WHO in public health
WHO fulfills its objectives through its core functions:
· Providing leadership on matters critical to health and engaging in partnerships where joint
action is needed;
· Shaping the research agenda and stimulating the generation, translation and dissemination of
valuable knowledge;
· Setting norms and standards and promoting and monitoring their implementation;
· Articulating ethical and evidence-based policy options;
· Providing technical support , catalyzing change, and building sustainable institutional
capacity; and
· Monitoring the health situation and assessing health trends.
Governance of WHO
WHO’s objective, as set out in its constitution, is the attainment by all people of the highest possible level
of health. The Constitution defines health as a state of complete physical, mental and social well-being and
not merely the absence of disease or infirmity. The World Health Assembly is the supreme decision-making
body for WHO. It meets each year in May in Geneva, and is attended by delegations from all 193
Member states.
The executive board is composed of 34 members technically qualified in the field of health. Members are
elected for three year terms. The main board meeting, at which the agenda for the forthcoming Health
Assembly is agreed upon and resolutions are adopted for forwarding to the Health Assembly, is held in
January, with a second shorter meeting in May, immediately after the Health Assembly, for more
administrative matters. The main functions of the Board are to give effect to the decisions and policies
Health Assembly, to advise it and generally to facilitate work.
The World Health Assembly is the supreme decision-making body for WHO. It generally meets in Geneva
in May each year, and is attended by delegations from all 193 member states. Its main function is to
determine the policies of the organization. The Health Assembly appoints the Director-General, supervises
the financial policies of the organization, and reviews and approves the proposed program budget. It
similarly considers reports of the executive Board, which it instructs in regard to matters upon which
further action, study, investigation or report may be required.
The secretariat of WHO is staffed by some 8000 health and other experts and support staff on fixed-term
appointments, working at headquarters, in the six regional offices, and in countries.
The organization is headed by the Director-General, who is appointed by the Health Assembly on the
nomination of the Executive Board.
The World Health Organization (WHO) is a specialized agency of the United Nations (UN) that acts as a
coordinating authority on international public health. Established on 7th April 1948, and headquartered in
Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health
Organization, which had been an agency of the League of Nations.
Mission

The WHO’s Constitution states that its objective is “the attainment by all people of the highest possible
level of health.” Its major task is to promote the general health of the people of the world.
Establishment
The World Health Organization is one of the original agencies of the United Nations, its Constitution
formally coming into force on the first World Health Day, (7th April 1948), when it was ratified by the 26th
member state. Prior to this, its operations as well as the remaining activities of the League of Nations
Health Organization were under the control of an Interim Commission following an International Health
Conference in summer of 1946. The transfer was authorized by a Resolution of the General Assembly. The
epidemiologic service of the French Office International d’Hygiene publique was incorporated into the
Interim Commission of the WHO on 1st January 1947.
Summary
As well as coordinating international efforts to monitor outbreaks of infectious diseases, such as SARS,
malaria, and AIDS, the WHO also sponsors programs to prevent and treat such diseases. The WHO
supports the development and distribution of safe and effective vaccines, pharmaceutical diagnostics and
drugs. After over 2 decades of fighting small pox, the WHO declared in 1980 that the disease had been
eradicated – the first disease in history to be eliminated by human effort.
The WHO aims to eradicate polio within the next few years. The organization had already endorsed the
world’s first official HIV/AIDS Toolkit for Zimbabwe (from 3rd October, 2006) making it an International
standard.
The WHO also conducts research on many things, sometimes this can be controversial, but it stands by its
recommendation based upon its own analysis of scientific studies.
INTRODUCTION TO ISO
ISO (International Organization for Standardization) is the world's largest developer and publisher of
International Standards.
ISO is a network of the national standards institutes of 163 countries, one member per country, with a
Central Secretariat in Geneva, Switzerland, that coordinates the system.
ISO is a non-governmental organization that forms a bridge between the public and private sectors. On the
one hand, many of its member institutes are part of the governmental structure of their countries, or are
mandated by their government. On the other hand, other members have their roots uniquely in the private
sector, having been set up by national partnerships of industry associations.
Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business
and the broader needs of society.
The ISO brand
* Democratic
Every full member of ISO has the right to take part in the development of any standard which it judges to
be important to its country's economy. No matter what the size or strength of that economy, each
participating member in ISO has one vote. Each country is on an equal footing to influence the direction of
ISO's work at the strategic level, as well as the technical content of its individual standards.
* Voluntary
ISO standards are voluntary. As a non-governmental organization, ISO has no legal authority to enforce the
implementation of its standards. ISO does not regulate or legislate. However, countries may decide to adopt
ISO standards - mainly those concerned with health, safety or the environment - as regulations or refer to
them in legislation, for which they provide the technical basis. In addition, although ISO standards are
voluntary, they may become a market requirement, as has happened in the case of ISO 9001 quality
management systems, or of dimensions of freight containers and bank cards.
ISO itself does not regulate or legislate.
* Market-driven

ISO only develops standards for which there is a market requirement. The work is mainly carried out by
experts from the industrial, technical and business sectors which have asked for the standards, and which
subsequently put them to use.
* Consensus
ISO standards are based on international consensus among the experts in the field. Consensus, like
technology, evolves and ISO takes account both of evolving technology and of evolving interests by
requiring a periodic review of its standards at least every five years to decide whether they should be
maintained, updated or withdrawn. In this way, ISO standards retain their position as the state of the art.
* Globally relevant
ISO standards are technical agreements which provide the framework for compatible technology
worldwide. They are designed to be globally relevant - useful everywhere in the world.
ISO standards are useful everywhere in the world.
How to recognize an ISO standard
In paper form, an ISO standard is published in A4 format - which is itself one of the ISO standard paper
sizes. It may be anywhere between a four-page document and one several hundred pages' long. ISO
standards are also available as electronic downloads and many are available as part of a collection on CD or
in handbook. An ISO standard carries the ISO logo and the designation, "International Standard".
The scope of ISO's work
ISO has more than 18 000 International Standards and other types of normative documents in its current
portfolio. ISO's work programme ranges from standards for traditional activities, such as agriculture and
construction, through mechanical engineering, manufacturing and distribution, to transport, medical
devices, information and communication technologies, and to standards for good management practice and
for services.
Examples of the benefits standards provide
Standardization of screw threads helps to keep chairs, children's bicycles and aircraft together and solves
the repair and maintenance problems caused by a lack of standardization that were once a major
headache for manufacturers and product users.
Standards establishing an international consensus on terminology make technology transfer easier and
safer. They are an important stage in the advancement of new technologies and dissemination of
innovation.
Without the standardized dimensions of freight containers, international trade would be slower and more
expensive.
Without the standardization of telephone and banking cards, life would be more complicated.
A lack of standardization may even affect the quality of life itself: for the disabled, for example, when
they are barred access to consumer products, public transport and buildings because the dimensions of
wheel-chairs and entrances are not standardized.
Standardized symbols provide danger warnings and information across linguistic frontiers.
Consensus on grades of various materials gives a common reference for suppliers and clients in business
dealings.
Agreement on a sufficient number of variations of a product to meet most current applications allows
economies of scale with cost benefits for both producers and consumers. An example is the
standardization of paper sizes.
Standardization of performance or safety requirements of diverse equipment makes sure that users' needs
are met while allowing individual manufacturers the freedom to design their own solution on how to meet
those needs.
Standardized computer protocols allow products from different vendors to "talk" to each other.
Standardized documents speed up the transit of goods, or identify sensitive or dangerous cargoes that may
be handled by people speaking different languages.
Standardization of connections and interfaces of all types ensures the compatibility of equipment of
diverse origins and the interoperability of different technologies.

Agreement on test methods allows meaningful comparisons of products, or plays an important part in
controlling pollution - whether by noise, vibration or emissions.
Safety standards for machinery protect people at work, at play, at sea... and at the dentist's.
Without the international agreement contained in ISO standards on metric quantities and units, shopping
and trade would be haphazard, science would be unscientific and technological development would be
handicapped.
What's different about ISO 9001 and ISO 14001
The vast majority of ISO standards are highly specific to a particular product, material, or process.
However, ISO 9001 (quality) and ISO 14001 (environment) are "generic management system
standards". "Generic" means that the same standard can be applied to any organization, large or small,
whatever its product or service, in any sector of activity, and whether it is a business enterprise, a public
administration, or a government department. ISO 9001 contains a generic set of requirements for
implementing a quality management system and ISO 14001 for an environmental management system.
Why conformity assessment is important
"Conformity assessment" means checking that products, materials, services, systems, processes or people
measure up to the specifications of a relevant standard or specification. Today, many products require
testing for conformity with specifications or compliance with safety, or other regulations before they can be
put on many markets. ISO guides and standards for conformity assessment represent an international
consensus on best practice. Their use contributes to the consistency of conformity assessment worldwide
and so facilitates trade.
What "international standardization" means
When the large majority of products or services in a particular business or industry sector conform to
International Standards, a state of industry-wide standardization exists. The economic stakeholders
concerned agree on specifications and criteria to be applied consistently in the classification of materials, in
the manufacture and supply of products, in testing and analysis, in terminology and in the provision of
services. In this way, International Standards provide a reference framework, or a common technological
language, between suppliers and their customers. This facilitates trade and the transfer of technology.
ISO's origins
In 1946, delegates from 25 countries met in London and decided to create a new international organization,
of which the object would be "to facilitate the international coordination and unification of industrial
standards". The new organization, ISO, officially began operations on 23 February 1947, in Geneva,
Switzerland.
Who can join ISO
Membership of ISO is open to national standards institutes most representative of standardization in their
country (one member in each country).
· Full members, known as member bodies, each have one vote, whatever the size or strength
of the economy of the country concerned.
· Correspondent members pay reduced membership fees. They are entitled to participate in
any policy or technical body as observers, with no voting rights.
· Subscriber members also pay reduced membership fees. They are institutes from countries
with very small economies that nevertheless wish to maintain contact with international
standardization.
Although individuals or enterprises are not eligible for membership, both have a range of opportunities for
taking part in ISO's work:
· Individuals may be selected by national member institutes to serve as experts on national
delegations participating in ISO technical committees
· Individuals and enterprises may provide their input during the process of developing a
national consensus for presentation by the delegation. This may done through national mirror
committees to the corresponding ISO technical committee

· International organizations and associations , both non-governmental and representing
industry sectors, can apply for liaison status to a technical committee. They do not vote, but can
participate in the debates and the development of consensus.
How the ISO system is managed
All strategic decisions are referred to the ISO members, who meet for an annual General Assembly. The
proposals put to the members are developed by the ISO Council, drawn from the membership as a whole,
which resembles the board of directors of a business organization.
ISO Council meets twice a year and its membership is rotated to ensure that it is representative of ISO's
membership.
ISO's operations are managed by a Secretary-General, which is a permanent appointment resembling the
chief executive of a business enterprise. The Secretary-General reports to the ISO Council, the latter being
chaired by the President who is a prominent figure in standardization or in business, elected for two years.
The Secretary-General is based at ISO Central Secretariat in Geneva, Switzerland, with a compact staff
which provides administrative and technical support to the ISO members, coordinates the decentralized
standards' development programme, and publishes the output.
How the ISO system is financed
ISO's national members pay subscriptions that meet the operational cost of ISO's Central Secretariat. The
subscription paid by each member is in proportion to the country's Gross National Income and trade
figures. Another source of revenue is the sale of standards.
However, the operations of ISO Central Secretariat represent only about one fifth of the cost of the system's
operation. The main costs are borne by the member bodies that manage the specific standards development
projects and the business organizations that provide experts to participate in the technical work. These
organizations are, in effect, subsidizing the technical work by paying the travel costs of the experts and
allowing them time to work on their ISO assignments.
How ISO decides to develop a standard
ISO launches the development of new standards in response to the sectors that express a clearly established
need for them. An industry or business sector communicates its requirement for a standard to one of ISO's
national members. The latter then proposes the new work item to ISO as a whole. If accepted, the work
item is assigned to an existing technical committee. Proposals may also be made to set up technical
committees to cover new scopes of activity.
At the end of 2006, there were 3041 technical bodies in the ISO system, including 193 ISO technical
committees.
The focus of the technical committees is specialized and specific. In addition, ISO has three general policy
development committees that provide strategic guidance for the standards' development work on cross-sector
aspects. These committees ensure that the specific technical work is aligned with broader market and
stakeholder group interests. They are:
· CASCO (conformity assessment)
· COPOLCO (consumer policy), and
· DEVCO (developing country matters)
Who develops ISO standards
ISO standards are developed by technical committees comprising experts from the industrial, technical and
business sectors which have asked for the standards, and which subsequently put them to use. These
experts may be joined by representatives of government agencies, testing laboratories, consumer
associations, non-governmental organizations and academic circles.
The experts participate as national delegations, chosen by the ISO national member institute for the
country concerned. These delegations are required to represent not just the views of the organizations in
which their participating experts work, but of other stakeholders too.
According to ISO rules, the member institute is expected to take account of the views of the range of
parties interested in the standard under development. This enables them to present a consolidated, national
consensus position to the technical committee.

ISO standards are developed by experts from the sectors which have asked for them.
How ISO standards are developed
The national delegations of experts of a technical committee meet to discuss, debate and argue until they
reach consensus on a draft agreement. This is circulated as a Draft International Standard (DIS) to ISO's
membership as a whole for comment and balloting.
Many members have public review procedures for making draft standards known and available to
interested parties and to the general public. The ISO members then take account of any feedback they
receive in formulating their position on the draft standard.
If the voting is in favour, the document, with eventual modifications, is circulated to the ISO members as
a Final Draft International Standard (FDIS). If that vote is positive, the document is then published as an
International Standard.
Every working day of the year, an average of eight ISO meetings are taking place somewhere in the world.
In between meetings, the experts continue the standards' development work by correspondence.
Increasingly, their contacts are made by electronic means and some ISO technical bodies have already gone
over entirely to working electronically, which speeds up the development of standards and cuts travel
costs.
INTERNATIONAL ORGANISATION FOR STANDERDISATION (ISO)
Introduction to ISO:
What are standards
Standards are documented agreements containing technical specifications or other precise criteria to be
used consistently as rules, guidelines , or definitions of characteristics , to ensure that materials , products
,processes and services are fit for their purpose.
For example , the format of the credit cards ,phone cards that have become commonplace is derived from
an ISO international standard .adhering to the standard , which defines such features as an optimal
thickness (0,76 mm), means that the cards can be used worldwide.
International standards thus contribute to making life simpler, and to increasing the reliability and
effectiveness of the goods and services we use.
What is ISO
The international organization for standerdisation(ISO) is a worldwide federation of national standards
bodies from 163 countries, one from each country.
ISO is a non-governmental organization established in 1947. The mission of ISO is to promote the
development of standardization and related activities in the world with a view to facilitating the
international exchange of goods and services, and to developing cooporation in the spheres of intellectual,
scientific, technological and economic activity.
ISO’s work results in international agreements which are published as international standards.
International standerdization began in the eletrotechnical field: the international electrotechnical
commission (IEC) was created in 1906. Pioneering work in other fields was carried out by the International
Federation of the National Standardizing Associations(ISA), WHICH WAS SET UP IN 1926.The
emphasis within ISA was laid heavily on mechanical engineering
ISA’s activities ceased in 1942 , owing to the second world war .following a meeting in Londonin 1946,
delegates from 25 countries decided to create a new international organization “ the object of which would
be to fecilitate the international coordination and unification of industrial standards ‘’.the new
organization ,ISO , began to function officially on 23 february 1947.
The first ISO standard was published in 1951 with the title “ Standard reference temperature for industrial
length measurement”.
ISO9000:

ISO 9000 is rapidly becoming most popular quality standard in the world. Thousands of organizations have
already adopted this important standard.ISO 9000 is an international document written by members of
worldwide delegates.ISO 9000 series was published in 1987 and is updated every 5 years.
ISO 9000 applies to all types of organizations.it can help both product and service oriented organizations
achieve standards of quality that are recognized and respected through out the world.
We can then develop a quality system that meets the quality requirements specified by one of the
following three standards:
ISO9001, ISO9002, OR ISO 9003.In the cource of doing so , we also consider ISO’s many guidelines.these
guidelines include ISO 9000, ISO 9004, ISO 10011, and ISO 10013.once the quality system has been
developed and implemented , we carry out an internal audit to make sure the system is working
properly.then we invite an accredited external auditor (registrar) to evaluate the effectiveness of the quality
system.if the auditors like what they see,they will certify that the quality system has met all of ISO
requirements.they will then issue an official certificate and they will record our achievement in their
registry. We can then announce to the world that the quality of the products and services is managed
,controlled, and assured by a registered ISO 9000 quality system.
ISO 9001
ISO 9001 is a quality assurance model made up of 20 sets of quality system requirements. This model
applies to organizations that design , develop , produce , install, and serviceproducts.ISO expects
organizations to apply this model, and to meet these requirements, by developing a quality system.
ISO 9000 4.1 - MANAGEMENT RESPONSIBILITIES
· Defines a quality policy. your policy should describe your organizations attitude towards
quality.
· Define the organizational structure that you will need in order to manage your quality
system.
 Define quality system responsibilities, give quality system personnel the the authority to carry out
these responsibilities, and ensure that the interactions these personnel are clearly specified. Also,
make sure that all of this is well documented.
 Identify and provide the resources that people will need to manage, perform,
and verify quality system work.
 Appoint a senior executive to manage your quality system and give him or
her the necessary authority.
· Define a procedure that your senior managers can use to review the effectiveness of your
quality system.
ISO 9001 4.2 –QUALITY SYSTEM REQUIREMENTS
· Develop a quality system and a manual that describe it.
· Develop and oimplement quality system procedures that are consistent with your quality
policy.
· Develop quality plans which show how you intend to fulfill quality system
requirements.your are expected to develop quality plans for products, projects , and customer
contracts.
ISO 9001 4.3 – CONTRACT REVIEW REQUIREMENTS
· Develop and document procedures ti coordinate the review of sales orders and customer
contracts. Make sure you include the customer in the process of review.
· Your contract review procedures should ensure that all contractual requirements are
acceptable before you agree to provide products or services to your customers.
· Develop procedures which specify how customer contracts are amended, and which ensure
that changes in contacts are communicated throughout the organization.

· Develop a record keeping system that you can use to document the review of customer
orders and contracts.
ISO 9001 4.4 - PRODUCT DESIGN REQUIREMENTS
· Develop and document procedures to control the product design and development
process.these procedures must ensure that all requirements are being met.
· Develop product design and development planning procedures.
· Identify the groups that should be routinely involved in the product design and development
process, and ensure that their design input is properly documented, circulated, and reviewed.
· Develop procedures to ensure that all design input requirements are identified , documented,
and reviewed; and that all design flaws, ambiguities, contraindications, and deficiencies are
resolved.
· Develop procedures to control design outputs.
· Develop procedures which specify how product design reviews should be planned and
performed.
· Develop procedures which specify how design outputs, at every stage of the product, design
and development process, should be verified.
· Develop procedures which validate the assumption that your newly designed products will
meet the customer needs.
· Develop procedures to ensurethat all product design modifications are documented,
reviewed, and formally authorized before the resulting documents are circulated and the changes
are implemented.
ISO 9001 4.5 - DOCUMENT AND DATA CONTROL
· Develop procedures to control quality system document and data.
· Develop procedures to review , approve, and manage all of your quality system
documents and data.
· Develop procedures to control changes to documents and data.
ISO 9001 4.6 – PURCHASING REQUIREMENTS
· Develop procedures to ensure that purchased products meet all requirements. These
procedures should control the selection of subcontractors, the use of purchasing data, and
the verification of the purchased products.
· Develop procedures to select , evaluate , monitor, and control your subcontractors
(your suppliers).make sure that quality records are kept which chronicle the performance
of all your subcontractors.your records should identify the acceptable subcontractors and
the products and services they provide.
· Develop procedures to ensure that your purchase order documents precisely describe
what you want to bye.
· Develop procedures that allow you or your customers to verify the acceptability of
products you have purchased.
ISO 9001 4.7 – CUSTOMER – SUPPLIED PRODUCTS
· Develop procedures to control products supplied to you by customers. These procedures
should ensure that you:
1) Examine the product when you recirve it to confirm that the right items were shipped
without loss or damage.
2) Prevent product loss, misuse, damage, or deterioration through proper storage and
security.
3) Record ,and report to the customer, any product loss, misuse, damage, or
deterioration.

4) Clarify who is responsible for the maintenance of the product while it is in your
possession.
ISO 9001 4.8 – PRODUCT IDENTIFICATION AND TRACING
Develop and document proceduresto identify and track products from start to finish. when appropriate these
procedures should ensure that you:
· Identify and document products every step of the way from the purchsa of supplies and
materials through all stages of handling, storage , production, delivery, installation, and servicing
· Trace products or product batches by means of unique identifiers and suitable record
keeping.
ISO 9001 4.9 - PROCESS CONTROL REQUIREMENTS
· Develop and document procedures to plan, monitor, and control your production,
installation and servicing processes.
· Design a record keeping system that monitors and controls process personnel and
equipment. Make sure that all important process qualities are monitored and recorded.
ISO 9001 4.10 – PRODUCT INSPECTION AND TESTING
· Develop procedures to inspect test, and verify that incoming , in –process , and final
products meet all specified requirements. Also ensure that appropriate product inspection and
testing records are developed, and that your procedures ensure that these records are properly
maintained.
· Develop procedures which ensure that incoming products are not used until you have
verified that they meet all specified requirements.
· Develop procedures which ensure that work- in – process meets all requirements before
work is allowed to continue.
· Develop procedures which ensure that final products meet all requirements before they are
made available for sale.
· Develop a record keeping system that your staff can use to document all product testing and
inspection activities.
ISI 9001 4.11 -CONTROL OF INSPECTION EQUIPMENT
· Develop procedures to control , calibrate, and maintain inspection, measuring, and test
equipment used to demonstrate that your product confirm to specified requirements(the term
equipment includes both hardware and software).
· Develop procedures to ensure that your measurement equipment is appropriate , effective,
and secure.
· Develop procedures to calibrate all of your quality oriented inspection, measuring, and test
equipment.
ISO 9001 4.12 – INSPECTION AND TEST STATUS OF PRODUCTS
Develop procedures to control the test status of your products. These procedures should ensure that:
· Each and every product is identified as having passed or failed the required tests and
inspections.
· The test status of each product is documented and respected throughout the production,
installation, and servicing process.
· Only products that have passed all tests and inspections are subsequiently used or sold to
customers(unless an official exception is made under section 4.13).
ISO 9001 4.13 – CONTROL OF NONCONFORMING PRODUCTS
· Develop procedures to prevent the inappropriate use of nonconfirming products.also make
sure that every one is notified when your products do not confirm to specified requirements.

· Develop proceduresto control how your nonconforming products are reviewed, reworked,
redraded, re-tested, recorded, and discussed.
ISO 9001 4.14 CORRECTIVE AND PREVENTIVE ACTION
· Develop procedures to correct or prevent nonconformities.
· Develop procedures to ensure that nonconformities are identified and corrected without
delay.
· Develop procedures to ensure that potential nonconformities are routinely detected and
prevented.
ISO 9001 4.15 – HANDLING , STORAGE, AND DELIVERY
· Develop and document procedures to handle, store, pakage, preserve , and deliver your
products.
· Develop product handling methods and procedures that prevent product damage or
deterioration.
· Designate secure areas to store and protect your products.
· Develop procedures which specify how your products will be placed into storage and
removed from storage.
· Develop procedures which specify how your products will be protected from damage or
deterioration from storage.
· Develop procedures which specify how your products will be monitored and evaluated to
detect damage or deterioration while in storage.
· Develop packing, packaging, and marking methods and procedures to protect and control
the quality of products and packaging materials.
· Develop methods and procedures to protect and preserve product quality prior to delivery
and while the product is still under your control.
· Develop procedures to protect your products after final testing and inspection, and during
product delivery.
ISO 9001 4.16 - CONTROL OF QUALITY RECORDS
· Identify and define the quality information that should be collected.
· Develop a quality record keeping system, and develop procedures to maintain and control it.
Develop procedure to:
1) collect and record quality information (create records)
2) file , index, store, and maintain quality records.
3) Remove ,archive, and destroy old quality records
4) Protect quality records from unauthorized access.
5) Prevent records from being altered without approval.
6) Safeguard records from damage or deterioration.
ISO 9001 4.17 – INTERNAL QUALITY AUDIT REQUIREMENTS
Develop internal quality audit procedures which:
· Determine whether quality activities and results comply with written quality plane,
procedures, and programs.
· Evaluate the performance of your quality system.
· Verify the effectiveness of your corrective actions.
These procedures should also ensure that :
· Audit activities are properly planned.
· Auditors are independent of the people being audited.
· Audit results , corrective actions, and corrective action results and consequences are
properly recorded.

· Audit conclusions are discussed with the people whose activities and results are being
audited, and deficiencies are corrected.
· Audit repots are fed back into the quality system review process.
ISO 9001 4.18 – TRAINING REQUIREMENTS
Develop quality training procedures. These procedures must ensure that :
· Quality system training needs are identified.
· Quality training is provided to those who need it.
· People are able to perform quality system jobs.
· People have the qualifications they need to do the work.
· Accurate and appropriate training records are kept.
· Everyone understands how your quality system works.
ISO 9001 4.19 - SERVICING REQUIREMENTS
Develop and document quality service procedures.your procedures should specify how:
· Products should be serviced.
· Product service activities are reported.
· The quality of product service is verified.
ISO 9001 4.20 - STATISTICAL TECHNIQUES
· Select the statistical techniques that you will need in order to establish , control , and verify
your process capabilities and product charecteristics.
· Develop procedures to explain how your techniques should be applied.
· Develop procedures to monitor and control how techniques are used.
· Make sure that all statistical procedures are documented.
· Make sure that proper statistical records are kept.
ISO 9002: QUALITY SYSTEMS -- MODEL FOR QUALITY ASSURANCE IN PRODUCTION ,
INSTALLATION AND SERVICING.
This standard applies to more routine production where product quality requirements can be adequately
expressed in terms of specifications. In these situations design criteria are either unimportant or have been
previously resolved. Confidence in supplier processing capability is required.
The production and supply of excipients and bulk pharmaceutical chemicals could fit into this standard,
which is probably the most extensively applied ISO9000 standard in the pharmaceutical industry.ISO 9002
is identical to ISO 9001 with the exclusion of section on the design control (4.4 )
ISO 9003 : QUALITY SYSTEM – MODEL FOR QUALITY ASSURANCE IN FINAL INSPECTION
AND TEST
This applies to contractual arrangements that rely on a suppliers ability to detect and control
nonconforming products by final testing or inspection. It is difficult to perceive a situation where this
would apply within the pharmaceutical industry—where quality must be built into designand production of
the product.one possible situation could be for the evaluation of production with low level of defectives
where inspection is used to cut out the defective units.
This standard is a condensed version of ISO 9002 with exclusion of specific section which do not apply:
purchasing (4.6), process control (4.9), servicing(4.19).
ISO 9004 : QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS.
This descriptive standard is currently eight parts, provides more detailed guidance on the quality elements
included in the registration /certification standards ISO 9001 , 9002 , and 9003.the eight parts are entitled :
1) Guidelines
2) Guidelines for services
3) Guidelines for processed materials
4) Guidelines for quality improvements
5) Guidelines for quality plans

6) Guidelines on quality assurance for project management
7) Guidelines for configuration management
8) And guidelines on quality principles and their application to management practices.
ISO 9001 series have to go further and must also demonstrate a capability /monitoring in all phases of
design development.
ISO 9002 suppliers are expected to go further and demonstrate that the relevant ,manufacturing processes
are capable of maintaining requirements as per design specifications. Ex.., performance and capability
studies.
ISO 9003 suppliers only have to demonstrate , among other things , a capability to impact and test a
product (eg.,) using proper acceptance sampling plan, monitoring test equipments etc.
U .S. FOOD AND DRUG ADMINISTATION
The U.S. Food and drug administration is an agency of the United States Department of Health and Human
services and is responsible for the safety regulation of most type of foods, dietary supplements, drug ,
vaccines, biological medical products, blood products, medical devices, radiation – emitting devices,
veterinary products, and cosmetics. The agency of the U.S. Department of Health and Human Services.
Established in 1927
History:
Origins of federal food and drug regulation :
The history of the FDA can be traced to the latter part of the 19 th century and the U.S Department of
Agriculture’s Division of Chemistry Under Harvey Washington Wiley, appointed chief chemist in 1883,
the division began conducting research into the adulteration and misbranding of food and drug on the
American market.
The 1906 Food and Drugs Act and creation of the FDA :
In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the “
Wiley Act ” after its chief advocate. The act prohibited, under penalty of seizure of foods, the interstate
transport of food which had been “ adulterated” with that term referring to the addition of
fillers of reduced “ quality or strength” , coloring to conceal “damage or inferiority” formulation with
additives “ injurious to health” or the use of “ filthy, decomposed, or putrid” substances.
The 1938 Food, Drug, and Cosmetic Act
By the 1930s , muckraking journalists, consumer protection organizations, and federal regulators began
mounting a compaign for stronger regulatory authority by publicizing a list of injurious products which
had been ruled permissible under the 1906 law including radioactive beverages, cosmetics which caused
blindness, and worthless “cures” for diabetes and tuberculosis.
Elixir sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic,
untested solvent. The only way that the FDA could even seize the product was due to a misbranding
problem: an “Elixir” was defined as a medication dissolved in ethanol, not the diethylene glycol used in
the Elixir Salfanilamidethe .
Early FD&C Act amendments:1938-1958:
The federal Food Drug and Cosmetic Act of 1938was passed after a legally marketed toxic elixir killed 107
people, including many children. The FD&C Act completed overhauled the public health system. Among
other provisions, the law authorized the FDA to demand evidence of safety for new drugs, issue standards
for food and conduct factory inspections.

Organization :
The agency is the organized in to the following major subdivisions each focused on a major area of
regulatory responsibility
The Office of the Commissioner(OC)
The Center for Drug Evaluation and Research (CDER)
The Center for Biologics Evaluation and Research (CBER)
The Center for Food Safety and Applied Nutrition (CFSAN)
The Center for Devices and Radiological Health (CDRH)
The Center for Veterinary medicine (CVM)
The Office of Regulatory Affairs (ORA)
The Office of Criminal Investigations( OCI)
The Office of the Commissioner(OC):
In the United States, the Commissioner of Food and Drugs is the head of the Food and Drug
Administration. The Commissioner report to the secretary of the Department of Health and Human
Services and is a presidential appointment with the advice and consent of the Senate.
The Center for Drug Evaluation and Research (CDER):
The center for Drug Evaluation and Research is a division of the FDA that monitors most drug as defined
in the FD&C Act. Some biological products are also legally considered drugs, but they are covered by the
center for Biological Evaluation and Research.
The center reviews applications for new and generic pharmaceuticals, manages US cGMP regulations for
pharmaceutical manufacturing, determines which medications require a prescription, monitors advertising
of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on
the market.
CDER is the largest of FDA’s five centers. It has responsibility for both prescription and over-the-counter
drugs.
CDER receives considerable public scrutiny, and thus implement processes that tend toward objectivity and
tend to isolated decisions from being attributed to specific individuals. In keeping with this, reviews are
generally staffed by teams that are intended to come to consensus on
Advertising and Promoting :
The FDA reviews and regulates prescription drug advertising and promotion. The federal Trade
Commission regulates. The drug advertising regulation contains two key requirements. Under most
circumstances, a company many only advertise a drug for the specific indication or medical use for which it
was approved. “Off-label use”, using a drug for other than its approved purpose is common in medical
practice. Also, an advertisement must contains “fair balance” between the benefits and risks of a drug .
Development & Approval Process New drugs
New drug receive extensive scrutiny before FDA approval in a process called a New Drug Application or
NDA. New drug are available only by prescription by default. A change to Over the counter (OTC) status
is a separate process and the drug must be approved through an NDA first.
CDER reviews New Drug Applications to ensure that the drug are safe and effective. It is one of the centers
at the united states Food and Drug Administration. Its primary objective is to ensure that all prescription
and over-the –counter ( OTC) medications are safe and effective when used as directed. The main
consumer watchdog in this system is the U.S Food and Drug Administration’s Center for Drug Evaluation
and Research (CDER).
The Center for Biologics Evaluation and Research (CBER):
The center for Biologics Evaluation and Research ( CBER) is one of six main center for the Food and
Drug Administration , which is a part of the U.S. Department of Health and Human Services.
The original authority for governmental regulation of biological product was eastablished by the 1902
Biologics Control Act, with additional authority established by the 1944 Public Health Service Act. Along
with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic product as well.

Originally, the entity responsible for regulation of biological products resided under the National Institutes
of Health ; this authority was transferred to the FDA in 1972
CBER is responsible for assuring the safety, purity, potency, and effectiveness of biological and related
product, including:
Blood and Blood Products :
The Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and a blood
components used for transfusion or for the manufacturing of pharmaceuticals derived from blood and blood
components, such as clotting factors, and establishes standards for the products themselves. CBER also
regulates related products such as cell separation devices, blood collection containers and HIV screening
tests that are used to prepare blood products or to ensure the safety of the blood supply. CBER develops
and enforces quality standards, inspects blood establishments and monitors reports of errors, accidents and
adverse clinical events.
Vaccines:
Vaccines, as with all products regulated by FDA, undergo a rigorous review of laboratory and clinical data
to ensure the safety, efficacy, purity and potency of these products. Vaccines approved for marketing may
also be required to undergo additional studies to further evaluate the vaccine and often to address specific
questions about the vaccine’s safety, effectiveness or possible side effects.
Cellular & Gene Therapy Products:
The center for Biologics Evaluation and Research (CBER) regulates vaccine products. Many of these are
childhood vaccines that have contributed to a significant reduction of vaccine – preventable diseases.
The center for Biologics and Research (CBER) regulates human gene therapy product – product that
introduce genetic materials into the body to replace faulty or missing genetic material, thus treating or
curing a disease or abnormal medical condition. CBER uses both the public Health Service Act and the
Federal Food Drug and Cosmetic Act as enabling statutes for oversight.
FDA has not yet approved any human gene therapy product for sale. However, the amount of gene –
related research and development occurring in the United States continues to grow at a fast rate and FDA
is actively involved in overseeing this activity. FDA has received many requests from medical research and
manufacturers to study gene therapy and to developed gene therapy products. Such research could lead to
gene based treatments for cancer, cystic fibrosis, heart disease, hemophilia, wounds, infectious diseases
such as AIDS, and graft- versus – host disease.
The Center for Food Safety and Applied Nutrition (CFSAN):
The center for food safety and Applied Nutrition is the branch of the FDA which is responsible for ensuring
the safety and accurate labeling of nearly all food product in the United States. One exception is meat
products derived from traditional domesticated animals, such as cattle and chickens, which fall under the
jurisdiction of the United States Department of Agriculture Food Safety and Inspection Service. FDA
regulates products, which contain minimal amount of meat and the exact boundaries are listed in a
memorandum of understanding between the two agencies however, the FDA through a different branch, the
center, regulating medicines and other products given to all domesticated animals for veterinary medicine
Labeling & Nutrition :
These FDA Food the labeling requirements for foods under the Federal Food Drug and Cosmetics Act and
its amendments. Food labeling is required for most prepared foods, such as breads, cereals, canned and
frozen foods, snacks, desserts, drinks, etc.
Cosmetics:
Cosmetics are regulating by the center for food safety and Applied Nutrition, the same branch of the FDA
that regulates food. Cosmetics products are not generally subject to premarket approval by the FDA
unless they make “structure or function claims” which make them into drugs. However, the FDA must

specifically approve all color additives before they can be included in cosmetic products sold in the U.S
The FDA regulates the labeling of cosmetics, and cosmetics which have not been subjected to through
safety testing, must bear a warning to that effect.
The Center for Devices and Radiological Health (CDRH):
The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food Drug
Administration responsible for the premarket approval of all medical devices. The CDRH also oversees the
radiation safety performance and safety of devices which emit certain type of electromagnetic radiation,
such as cellular phones and microwaves ovens.
The Center for Veterinary medicine (CVM)
The Center for Veterinary medicine (CVM) is a branch of the FDA, which regulates the manufacture, and
distribution of food, food additives, and drugs that will be given to animals. These include animals, from
which human food are derived, as well as food additives and drug for pets or companion animals. CVM is
responsible for regulating drugs, devices, and food additives given to or used on, over one hundred million
companion animals, plus millions of poultry, cattle, swine, and minor animals species.
(minor animals species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats. )
The Office of Regulatory Affairs (ORA):
ORC and OCI are primarily filed offices, with their workforce spread across the country . ORC is
considered the “eyes and ears” of the agency, conducting the vast majority of the field work the agency.
Consumer safety officers, more commonly called investigators, are the individuals who inspects production
and warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in the
case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a
physical examination or take a physical sample of the products.
The Office of Criminal Investigations( OCI)
OCI was established in 2002 to help relieve ORC of the burden of pursuing and proving criminal cases.
Unlike ORA investigators, OCI Special Agents are armed, and are not focused on the technical aspects of
whether a regulated product meets the standards under the law. Rather, OCI agents pursue and develop
cases where criminal action have occurred, such as fraudulent claims, or khowingly and will fully shipping
known adulterated goods in interstate commerce.
The FDA frequently works in conjunction with other federal agencies including the department of
agriculture, Drug Enforcement Administration, customs and Border protection, and Consumer product
Safety Commission. Often local and state government agencies also work in cooperation with the FDA to
provide regulatory inspection and enforcement action.

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