Good Manufacturing Practices by RK Vidyarthi

GOOD MANUFACTURING PRACTICES
Department of Pharmaceutical Sciences,
Bhimtal
SUPERVISOR :
Dr. Rajeshwar K.K. Arya
Assistant Professor
(Pharmaceutics)
PRESENTED BY:
Raveendra Kumar Vidyarthi
Research Scholar
(Pharmaceutics)

Definition
 That part of QA which ensures that products
are consistently produced and controlled to the
quality standards as per the product
specifications.

A Timeline of GMP
 1902- Development of Biologic Control Act
 1906- Development of Pure Food and Drug Act
 1938- Federal Food, Drug and Cosmetic Act
 1941- Initiation of GMP
 1944- Development of Public Health Service Act
 1962- Kefauver- Harris Drug Amendments released
 1963- Establishment of GMPs for Drugs
 1975- cGMPs for Blood and Components Final Rule
 1976- Medical Devices Amendments
 1978- cGMP for Drugs and Medical Devices
 1979- GLPs Final Rules
 1980- Infant Formula Act was passed

1941- Initiation of GMP
 Sulphathiazole tablets contaminated with
phenobarbital
 1941- 300 people were died
 US-FDA promulgated GMP under the authority
of Federal Food Drug and Cosmetic act to
ensure safety purity and effectiveness of drug
products and medical devices.
 1941- GMP is born

1960-Thalidomide tragedy
 1960-Thalidomide marketed in West Germany
then Canada & Britain as sleeping tablet,
treatment of colds, flu etc and also for
controlling morning sickness in pregnant
women.
 1961- thousands of children were born with
birth defects due to ADR of pill taken by
mothers.
 1961- withdrawal of thalidomide
DEMONSTRATED THAT SAFETY
REQUIREMENTS OF NEW DRUGS HAD TO
BE TIGHTENED

1) CFR : Code of Federal Regulation such as
1,2,3,….50. eg. 21CFR-Food and Drug
2) Chapter: I, II, III etc
3) Parts: There are parts in every CFR. Like
Part 211of is cGMP for finished
pharmaceuticals of the CFR 21.
4) Subparts: such as A,B,C,D etc
5) Section: e.g. Section 221.1 scope & 221.2
for Definition
GUIDELINES

Areas to be covered
 A- General considerations
 B- Personnel
 C- Buildings and facilities
 D- Equipment
 Raw material
 F- Production and Process Control
 G-Packaging and Labeling control
 I- Laboratory controls
 J-Records and Reports

General Consideration
 Why Do We Need GMP?

Types of Contamination
 PARTICULATES
(dust, dirt, paper, metal, fibres, etc)
 MICROORGANISMS
(Bacteria, yeast, molds)
 CROSS- CONTAMINATION
(labels, cartons, foil, materials etc)

Sources of Contamination
 AIR
 WATER
 SURFACES
 PEOPLE
 PESTS

MICROORGANISMS CAN BE
DESTROYED OR REDUCED BY
 Personal Hygiene
 Insect and pest control
 Clean and potable water
 Correct cleaning & sanitizing of
equipment
 Effective cleaning of processing areas,
storage areas warehouse, etc.

Need of GMP
 Consistency + Control = Quality Products
 We can’t TEST QUALITY into a product at the
end
 To achieve a quality products we must BUILD
QUALITY into each batch of product during all
stages of the manufacturing process

Contd…
 It is Designed to minimize the risks involved in
any pharmaceutical production that cannot be
eliminated through testing the final product.
 Poor quality medicine may contain toxic
substances that have been unintentionally
added

Some of the main Risks are
 Unexpected contamination of products,
causing damage to health or even death.
 Incorrect labels on containers, which could
mean that patients receive the wrong
medicine.
 Insufficient or too much active ingredient,
resulting in ineffective treatment or adverse
effects.

GMP Covers
 ALL aspects of Production; from the starting materials,
premises and equipment to the training and personal
hygiene of staff.
 Detailed, written procedures are essential for each
process that could affect the quality of the finished
product.
 There must be systems to provide documented proof
that correct procedures are consistently followed at each
step in the manufacturing process -every time a product
is made.

GMP statements
 Three P’s of GMP:
 Performance
 Pride
 Proof

Personnel
 The Quality of a formulation or a bulk drug
depends on the quality of those producing it.
 Qualified Personnel
A) Experienced
B) Sufficient Number
 Written job description
 Trained
 Health
A) Diseases
B) Open lesions

Premises
 Points to be Consider:
 Location
 Design
 Construction

Premises Location
 Geography, climate and economic factors
 Neighbours
 Premises must be located to minimize risks of
cross-contamination,
 (e.g not located next to malting factory with high
level of airborne yeast)
 Pollution/effluent control

Contd..
 Minimize risks of errors
 Permits effective cleaning
 Permits effective maintenance
 Maximum protection against entry of insects,
birds and animals
 Separate facilities for other products such as
some antibiotics, hormones, cytotoxic
substances

Contd…
 Specific Areas
 Production areas
 Quality control areas
 Weighing areas
 Storage areas
 Ancillary areas

Contd…
 Hygiene
 Eating, Drinking, smoking should not be
allowed in the production area

Premises Construction
 Measures should be taken to prevent cross-
contamination
 Dust control measures (including extraction of
dust and air)
 No areas for dust accumulation
 Easily cleanable surfaces, should be smooth
and hard wearing
 Use of HEPA filters
 Proper lightening system

Equipments
 1. Equipment design, size, and location.
 2. Equipment construction.
 3. Equipment cleaning and maintenance.
 4. Automatic, mechanical, and electronic
equipments
 5. Filters

Equipments (contd…)
 Equipment design must be carefully
examined.
 Dedicated equipment should be used for
products which are difficult to remove,
difficult to clean and for products with a
high safety risk.
 Should be made of non-reactive materials
such as high grade of steel (316,302)

 Must be made of materials that will not react with
or absorb any components they contact.
 Must be designed for the particular purpose for
which it is intended.
 Must be located for easy maintenance.
 Substances used for operation like lubricants,
coolants should not come in contact with the
product.

 Equipment should be-
 A) calibrated
 B) checked
 C) labeled
 D) sterilized

 All Equipments Must Have:
 An accurate well documented log showing what
was produced in it.
 A cleaning log showing when, how and by
whom each piece of equipment was cleaned.
 All equipment must have an identification
number which should appear on the batch
records.
 Validated

Raw Materials (contd…)
 Certificate of analysis
 Full analysis is must
 Equivalency of testing must
be established for new supplier
Supplier must use same testing
methods as the user

Raw Materials (contd…)
 An inventory should be maintained for Raw materials
to be used at any stage of manufacture
 Records should be maintained as per Schedule U
 Must be checked by QC department on Receipt
 Should be properly labeled

Labels and Printed Materials
 Should have identifying code number or marks
 Must be checked against a standard or artwork upon
receipt
 Obsolete materials must be removed from the control
system and inventory
 Specimen must be signed off by QA to indicate approval
 Labels and printed materials issued only when authorized

Contd…
 All containers and equipment should bear labels
 Different color coded labels should be used to
indicate the status of a product
 (for example under test, approved, passed, rejected)
 The label should contain all the prescribed
details about the product.

Complaints
 All complaints and other information
concerning potentially defective
product
must be carefully reviewed and
investigated according to written
procedures.

Complaints (contd…)
 Any complaints of a product is automatically
investigated.
 The entire Batch Production Record and Batch
Control Record must be reviewed.

 The source and content of deficiencies, remedial
measures taken and tests performed should be
documented in writing and added to the batch records.
 Consideration should be given to check if other batches
could be affected and cease supply until the problem is
fully investigated.
 Product recall should be initiated if deficiency is
potentially harmful to health.

 The progress of recall should be recorded.
 A final report should be issued, including
reconciliation between the delivered and recovered
quantities of the questionable product.

References
 FDA Food and Drug Administration. GMP combination
Handbook. 31.Aug. 2008.
 The Center for Professional Advancement. Good
Manufacturing Practice. 1.Sep. 2008.
 FDA Food and Drug administration. GMP Combination
Handbooks. 28. june.2012.
 Khar R.K, Vyas S.P, Ahmed F.J, Jain G.K. The theory and
Practice of industrial pharmacy. 4th Ediiton , CBS publishers,
pp-1108-35.
 Sawant D.A, Ambulge J.K. The Pharmaceutical
Sciences:Pharma pathway “Industrial and applied pharmacy”.
13th Edition, Nirali prakashan, june 2014. pp-2.1-2.11.

Good Manufacturing Practices by RK Vidyarthi

Good Manufacturing Practices by RK Vidyarthi

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