Project on sop part 2

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1.0 INTRODUCTION
1.1 Overview
A Standard Operating Procedure (SOP) is a set of written instructions that document a
routine or repetitive activity followed by an organization. The development and use of SOPs
are an integral part of a successful quality system as it provides individuals with the
information to perform a job properly, and facilitates consistency in the quality and integrity
of a product or end-result. The term “SOP” may not always be appropriate and terms such as
protocols, instructions, worksheets, and laboratory operating procedures may also be used.
For this document “SOP” will be used.
SOPs describe both technical and fundamental programmatic operational elements of an
organization that would be managed under a work plan or a Quality Assurance (QA) Project
Plan [EPA Requirements for QA Project Plans (QA/R-5) (EPA 2001a)], or Chapter 5 of the
EPA Quality Manual for Environmental Programs, (EPA Manual 5360 A) and under an
organization’s Quality Management Plan [EPA Requirements for Quality Management Plans
(QA/R-2) (EPA 2001b)], or Chapter 3 of the EPA Quality Manual. This document is
designed to provide guidance in the preparation and use of an SOP within a quality system.
1.2 Purpose
SOPs detail the regularly recurring work processes that are to be conducted or followed
within an organization. They document the way activities are to be performed to facilitate
consistent conformance to technical and quality system requirements and to support data
quality. They may describe, for example, fundamental programmatic actions and technical
actions such as analytical processes, and processes for maintaining, calibrating, and using
equipment. SOPs are intended to be specific to the organization or facility whose activities
are described and assist that organization to maintain their quality control and quality
assurance processes and ensure compliance with governmental regulations.
If not written correctly, SOPs are of limited value. In addition, the best written SOPs will fail
if they are not followed. Therefore, the use of SOPs needs to be reviewed and re-enforced by
management, preferably the direct supervisor. Current copies of the SOPs also need to be
readily accessible for reference in the work areas of those individuals actually performing the
activity, either in hard copy or electronic format, otherwise SOPs serve little purpose.

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1.3 Benefits
The development and use of SOPs minimizes variation and promotes quality through
consistent implementation of a process or procedure within the organization, even if there are
temporary or permanent personnel changes. SOPs can indicate compliance with
organizational and governmental requirements and can be used as a part of a personnel
training program, since they should provide detailed work instructions. It minimizes
opportunities for miscommunication and can address safety concerns. When historical data
are being evaluated for current use, SOPs can also be valuable for reconstructing project
activities when no other references are available. In addition, SOPs are frequently used as
checklists by inspectors when auditing procedures. Ultimately, the benefits of a valid SOP are
reduced work effort, along with improved comparability, credibility, and legal defensibility.
SOPs are needed even when published methods are being utilized. For example, if an SOP is
written for a standard analytical method, the SOP should specify the procedures to be
followed in greater detail than appear in the published method. It also should detail how, if at
all, the SOP differs from the standard method and any options that this organization follows.
As noted in ASTM D5172-91 (2004), Standard Guide for Documenting the Standard
Operating Procedures Used for the Analysis of Water, “a significant part of the variability of
results generated by different laboratories analyzing the same samples and citing the same
general reference is due to differences in the way the analytical test methods and procedures
are actually performed in each laboratory. These differences are often caused by the slight
changes or adjustments allowed by the general reference, but that can affect the final results."
Using a correct well-written SOP can minimize such differences.
1.4 Create SOP to grow
Above all, freelancers and small business owners should consider creating SOPs so that their
practice can grow.
It's likely that you didn't start your small business for the sole purpose of creating invoices.
You went out and began offering your services because of the passion you've got for your
work, not all of the administrative stuff that comes along with it.
But you also know that you can't merely neglect these business processes. Invoicing, for
example, is crucial to maintain your business and continue your creative work. This is the

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ideal task that should have an SOP built for it so that it can potentially be outsourced or
handled by others.
Going from being a single person creative practice to a growing, thriving business requires
implementing these scalable processes that you can outsource or hand off to other team
members.
I'm sure that no one gets excited by the thought of writing SOPs. But growing your practice is
all about putting scalable systems in place that can grow with your workload. Part of that is
developing SOPs for these business-critical processes. Let's talk about how to build them.
1.5 Writing Styles
SOPs should be written in a concise, step-by-step, easy-to-read format. The information
presented should be unambiguous and not overly complicated. The active voice and present
verb tense should be used. The term "you" should not be used, but implied. The document
should not be wordy, redundant, or overly lengthy. Keep it simple and short. Information
should be conveyed clearly and explicitly to remove any doubt as to what is required. Also,
use a flow chart to illustrate the process being described. In addition, follow the style guide
used by your organization, e.g., font size and margins.
1.5.1 How to write SOP
Standard operating procedures can take some forms, but perhaps the most popular format is a
text document that includes a step-by-step list to follow. Let's build an example of an SOP
(standard operating procedure) for issuing invoices to clients at month-end.
1. State the "Why"
It's hard to get buy-in on making SOPs if the reader or preparer doesn't understand why the
work matters. That's why I always start with why.

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For my standard operating procedure example, I'll keep it simple. The purpose of creating
invoices is simple: to get paid! Including that as the reasoning will help anyone know that this
process matters and that it's vital to run each month.
Also, make sure to include some administrative details on who should maintain the SOP.
That identifies who'll work on it.
2. Frame the Process
Where does the documented process fit into the overall business picture? When should it be
performed, and what other steps are required before it can be completed? Many processes are
dependent on other steps, so make sure that this is captured.
When is the task performed, and how often is it performed? These are all details that have to
be captured in an SOP so that anyone can be followed by others.

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3. Create Detailed, Concrete Steps
Now, we've arrived at the most important part of the SOP building process: simple steps that
anyone can follow.
Document the steps involved with the process. Make them as simple as possible. For me, I
find it easiest to write an SOP step list while performing the task for myself so that nothing is
forgotten.
It's possible that you may need to include conditionals in your list. It's okay to start with a
step with "if...", as long as you address the scenario.
For me, I typically use Trello for my freelancing practice. Screenshots that I would include an
SOP would include walkthroughs of how to perform a task in Trello, for example. Keep in
mind that the user may have never used the system, so more detail is always helpful.
4. Test the SOPs
Here's the best way to test out the viability of your standard operating procedures: try handing
them off, and see if they break.
I know that when I'm writing standard operating procedures, I'm guilty of forgetting the
beginner's perspective. I've likely been doing the task for so long that I've forgotten what it's
like to start with no knowledge of the process.

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This is why testing is so important. You've got to put the SOPs into action to see if others
understand them. Hand it off to a freelancer or another team member to see if it makes sense
to someone new.
5. Most Importantly: Store and Review Periodically
After you've developed the SOPs, you've come to the most important part of the process:
distributing and making them useful. Too many teams view creating SOPs as a one-time
process that doesn't need regular maintenance. Well-created documentation isn't useful unless
it's distributed and utilized.
First, it's crucial that you've got a place that you can store SOPs so that everyone who'll be
impacted by them can access them. This could be a Dropbox share, a shared network drive,
or even an intranet page.
Above all, the SOPs should be accessible and stored in only one place. I've seen them
become useless because everyone begins to maintain separate copies of the file and they soon
become out-of-sync. Ensure that everyone is working from the same master copy so that
SOP's maintain the usefulness that they were intended for.
6. Making SOPs "Living Documents"
I've worked in many situations where writing documentation and SOPs is a one-time process.
A big push happens from upper management to document active processes, and the team
spends many hours documenting standard operating procedures.
Six months later, processes are evolving and changing. And the SOPs lag behind, not updated
to match the reality of the new process. Pretty soon, no one is using the SOPs because they
aren't representative of how the process works.
To combat this, you need to periodically update the SOPs so that they don't get too far out of
sync. It's critical that standard operating procedures are reviewed regularly by the maintainer.

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Every SOP should have a process owner who is accountable for updating and editing it
periodically to make sure that it matches the current process. This is the only way that SOPs
maintain their usefulness and are used by your team.
2.0 SOP Process
2.1 SOP Preparation
The organization should have a procedure in place for determining what procedures or
processes need to be documented. Those SOPs should then be written by individuals
knowledgeable with the activity and the organization's internal structure. These individuals
are essentially subject-matter experts who actually perform the work or use the process. A
team approach can be followed, especially for multi-tasked processes where the experiences
of a number of individuals are critical, which also promotes “buy-in” from potential users of
the SOP.
SOPs should be written with sufficient detail so that someone with limited experience with
or knowledge of the procedure, but with a basic understanding, can successfully reproduce
the procedure when unsupervised. The experience requirement for performing an activity
should be noted in the section on personnel qualifications. For example, if a basic chemistry
or biological course experience or additional training is required that requirement should be
indicated.
2.2 SOP Review and Approval
SOPs should be reviewed (that is, validated) by one or more individuals with appropriate
training and experience with the process. It is especially helpful if draft SOPs are actually
tested by individuals other than the original writer before the SOPs are finalized.
The finalized SOPs should be approved as described in the organization’s Quality
Management Plan or its own SOP for preparation of SOPs. Generally the immediate
supervisor, such as a section or branch chief, and the organization’s quality assurance officer
review and approve each SOP. Signature approval indicates that an SOP has been both

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reviewed and approved by management. As per the Government Paperwork Elimination Act
of 1998, use of electronic signatures, as well as electronic maintenance and submission, is an
acceptable substitution for paper, when practical.
2.3 Frequency of Revisions and Reviews
SOPs need to remain current to be useful. Therefore, whenever procedures are changed,
SOPs should be updated and re-approved. If desired, modify only the pertinent section of an
SOP and indicate the change date/revision number for that section in the Table of Contents
and the document control notation.
SOPs should be also systematically reviewed on a periodic basis, e.g. every 1-2 years, to
ensure that the policies and procedures remain current and appropriate, or to determine
whether the SOPs are even needed. The review date should be added to each SOP that has
been reviewed. If an SOP describes a process that is no longer followed, it should be
withdrawn from the current file and archived.
The review process should not be overly cumbersome to encourage timely review. The
frequency of review should be indicated by management in the organization’s Quality
Management Plan. That plan should also indicate the individual(s) responsible for ensuring
that SOPs are current.
2.4 Checklists
Many activities use checklists to ensure that steps are followed in order. Checklists are also
used to document completed actions. Any checklists or forms included as part of an activity
should be referenced at the points in the procedure where they are to be used and then
attached to the SOP.
In some cases, detailed checklists are prepared specifically for a given activity. In those
cases, the SOP should describe, at least generally, how the checklist is to be prepared, or on
what it is to be based. Copies of specific checklists should be then maintained in the file with

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the activity results and/or with the SOP. Remember that the checklist is not the SOP, but a
part of the SOP.
2.5 Document Control
Each organization should develop a numbering system to systematically identify and label
their SOPs, and the document control should be described in its Quality Management Plan.
Generally, each page of an SOP should have control documentation notation, similar to that
illustrated below. A short title and identification (ID) number can serve as a reference
designation. The revision number and date are very useful in identifying the SOP in use when
reviewing historical data and is critical when the need for evidentiary records is involved and
when the activity is being reviewed. When the number of pages is indicated, the user can
quickly check if the SOP is complete. Generally this type of document control notation is
located in the upper right-hand corner of each document page following the title page.
2.6 SOP Document Tracking and Archival
The organization should maintain a master list of all SOPs. This file or database should
indicate the SOP number, version number, date of issuance, title, author, status,
organizational division, branch, section, and any historical information regarding past
versions. The QA Manager (or designee) is generally the individual responsible for
maintaining a file listing all current quality-related SOPs used within the organization. If an
electronic database is used, automatic “Review SOP” notices can be sent. Note that this list
may be used also when audits are being considered or when questions are raised as to
practices being followed within the organization.
As noted above in Section 2.3, the Quality Management Plan should indicate the
individual(s) responsible for assuring that only the current version is used. That plan should
also designated where, and how, outdated versions are to be maintained or archived in a
manner to prevent their continued use, as well as to be available for historical data review.
Electronic storage and retrieval mechanisms are usually easier to access than a hard-copy
document format. For the user, electronic access can be limited to a read-only format, thereby
protecting against unauthorized changes made to the document.

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3.0 SOP General formate
SOPs should be organized to ensure ease and efficiency in use and to be specific to the
organization which develops it. There is no one “correct” format; and internal formatting will
vary with each organization and with the type of SOP being written. Where possible break
the information into a series of logical steps to avoid a long list. The level of detail provided
in the SOP may differ based on, e.g., whether the process is critical, the frequency of that
procedure being followed, the number of people who will use the SOP, and where training is
not routinely available. A generalized format is discussed next.
3.1 Title Page
The first page or cover page of each SOP should contain the following information: a title
that clearly identifies the activity or procedure, an SOP identification (ID) number, date of
issue and/or revision, the name of the applicable agency, division, and/or branch to which this
SOP applies, and the signatures and signature dates of those individuals who prepared and
approved the SOP. Electronic signatures are acceptable for SOPs maintained on a
computerized database.
3.2 Table of Contents
A Table of Contents may be needed for quick reference, especially if the SOP is long, for
locating information and to denote changes or revisions made only to certain sections of an
SOP.
3.3 Text
Well-written SOPs should first briefly describe the purpose of the work or process, including
any regulatory information or standards that are appropriate to the SOP process, and the
scope to indicate what is covered. Define any specialized or unusual terms either in a separate
definition section or in the appropriate discussion section. Denote what sequential procedures

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should be followed, divided into significant sections; e.g., possible interferences, equipment
needed, personnel qualifications, and safety considerations (preferably listed in bold to
capture the attention of the user). Finally, describe next all appropriate QA and quality
control (QC) activities for that procedure, and list any cited or significant references.
As noted above, SOPs should be clearly worded so as to be readily understandable by a
person knowledgeable with the general concept of the procedure, and the procedures should
be written in a format that clearly describes the steps in order. Use of diagrams and flow
charts help to break up long sections of text and to briefly summarize a series of steps for the
reader.
Attach any appropriate information, e.g., an SOP may reference other SOPs. In such a case,
the following should be included:
1. Cite the other SOP and attach a copy, or reference where it may be easily located.
2. If the referenced SOP is not to be followed exactly, the required modification should be
specified in the SOP at the section where the other SOP is cited.
More information on text is contained in Section 4.1 for Technical SOPs and Section 4.2 for
Administrative SOPs.
4.0 Types of SOPs
SOPs may be written for any repetitive technical activity, as well as for any administrative or
functional programmatic procedure, that is being followed within an organization. General
guidance for preparing both technical and administrative SOPs follows and examples of each
are located in the Appendix.
4.1 Guidelines for Technical SOP Text
Technical SOPs can be written for a wide variety of activities. Examples are SOPs instructing
the user how to perform a specific analytical method to be followed in the laboratory or field
(such as field testing using an immunoassay kit), or how to collect a sample in order to
preserve the sample integrity and representativeness (such as collection of samples for future

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analysis of volatile organic compounds or trace metals), or how to conduct a bioassessment
of a freshwater site. Technical SOPs are also needed to cover activities such as data
processing and evaluation (including verification and validation), modeling, risk assessment,
and auditing of equipment operation.
Citing published methods in SOPs is not always acceptable, because cited published methods
may not contain pertinent information for conducting the procedure-in-house. Technical
SOPs need to include the specific steps aimed at initiating, coordinating, and recording and/or
reporting the results of the activity, and should be tailored only to that activity. Technical
SOPs should fit within the framework presented here, but this format can be modified,
reduced, or expanded as required. Examples of technical SOPs are located in the Appendices
A, B, and C.
In general, technical SOPs will consist of five elements: Title page, Table of Contents,
Procedures, Quality Assurance/Quality Control, and References:
1. Title Page - See Section 3.1.
2. Table of Contents - See Section 3.2.
3. Procedures - The following are topics that may be appropriate for inclusion in technical
SOPs. Not all will apply to every procedure or work process being detailed.
A. Scope and Applicability (describing the purpose of the process or procedure and any
organization or regulatory requirements, as well as any limits to the use of the
procedure),
B. Summary of Method (briefly summarizing the procedure),
C. Definitions (identifying any acronyms, abbreviations, or specialized terms used),
D. Health & Safety Warnings (indicating operations that could result in personal injury
or loss of life and explaining what will happen if the procedure is not followed or is
followed incorrectly; listed here and at the critical steps in the procedure),
E. Cautions (indicating activities that could result in equipment damage, degradation of
sample, or possible invalidation of results; listed here and at the critical steps in the
procedure),
F. Interferences (describing any component of the process that may interfere with the
accuracy of the final product),

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G. Personnel Qualifications/Responsibilities (denoting the minimal experience the user
should have to complete the task satisfactorily, and citing any applicable
requirements, like certification or “inherently governmental function”),
H. Equipment and Supplies (listing and specifying, where necessary, equipment,
materials, reagents, chemical standards, and biological specimens),
I. Procedure (identifying all pertinent steps, in order, and the materials needed to
accomplish the procedure such as:
 Instrument or Method Calibration and Standardization
 Sample Collection
 Sample Handling and Preservation
 Sample Preparation and Analysis (such as extraction, digestion, analysis,
identification, and counting procedures)
 Troubleshooting
 Data Acquisition, Calculations & Data Reduction Requirements (such as listing any
mathematical steps to be followed)
 Computer Hardware & Software (used to store field sampling records, manipulate
analytical results, and/or report data), and
j. Data and Records Management (e.g., identifying any calculations to be performed, forms
to be used, reports to be written, and data and record storage information).
4. Quality Control and Quality Assurance Section –
QC activities are designed to allow self-verification of the quality and consistency of the
work. Describe the preparation of appropriate QC procedures (self-checks, such as
calibrations, recounting, reidentification) and QC material (such as blanks - rinsate, trip, field,
or method; replicates; splits; spikes; and performance evaluation samples) that are required to
demonstrate successful performance of the method. Specific criteria for each should be
included. Describe the frequency of required calibration and QC checks and discuss the
rationale for decisions. Describe the limits/criteria for QC data/results and actions required
when QC data exceed QC limits or appear in the warning zone. Describe the procedures for
reporting QC data and results.

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5. Reference Section –
Documents or procedures that interface with the SOP should be fully referenced (including
version), such as related SOPs, published literature, or methods manuals. Citations cannot
substitute for the description of the method being followed in the organization. Attach any
that are not readily available.
As with the technical SOPs, these SOPs can be written for a wide variety of activities, e.g.,
reviewing documentation such as contracts, QA Project Plans and Quality Management
Plans; inspecting (auditing) the work of others; determining organizational training needs;
developing information on records maintenance; validating data packages; or describing
office correspondence procedures. Administrative SOPs need to include a number of specific
steps aimed at initiating the activity, coordinating the activity, and recording and/or reporting
the results of the activity, tailored to that activity. For example, audit or assessment SOPs
should specify the authority for the assessment, how auditees are to be selected, what will be
done with the results, and who is responsible for corrective action. Administrative SOPs
should fit within the framework presented here, but this format can be modified, reduced, or
expanded. An example of administrative SOPs can be found in Appendix E.
In general, administrative/programmatic SOPs will consist of five elements: Title page,
Table of Contents, Purpose, Procedures, Quality Assurance/Quality Control, and References.
1. Title Page - See Section 3.1.
2. Table of Contents - See Section 3.2.
3. Procedures -The following are topics that may be appropriate for inclusion in
administrative SOPs:
a. Purpose – (identifying the intended use of the process)
b. Applicability/Scope (identifying when the procedure is to be followed),
c. Summary of Procedure,
d. Definitions (defining any words, phrases, or acronyms having special meaning
or application),
e. Personnel Qualifications/Responsibilities (identifying any special
qualifications users should have such as certification or training experience
and/or any individual or positions having responsibility for the activity being
described),
f. Procedure,

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g. Criteria, checklists, or other standards that are to be applied during the
procedure such as citing this document as guidance for reviewing SOPs), and
h. Records Management (specifically, e.g., as forms to be used and locations of
files).
4. Quality Control and Quality Assurance Section - Describe any control steps and
provisions for review or oversight prior to acceptance of the product or deliverable.
This can include test plans such as verification and validation plans for software or
running a “spell-check” program on the finished document.
5. Reference Section - Cite all references noted in the body of the SOP. A copy of any
cited references not readily available should be attached to the SOP.
Other good practices:-
Other good-practice systems, along the same lines as GMP, exist:-
 Good agricultural practice (GAP), for farming and ranching
 Good clinical practice (GCP), for hospitals and clinicians conducting clinical studies on
new drugs in humans
 Good distribution practice (GDP) deals with the guidelines for the proper distribution of
medicinal products for human use
 Good laboratory practice (GLP), for laboratories conducting non-clinical
studies (toxicology and pharmacology studies in animals)
 Good pharmacovigilance practice (GVP), for the safety of produced drugs
 Good regulatory practice (GRP), for the management of regulatory commitments,
procedures and documentation
This document is intended to provide guidance regarding good manufacturing practice
(GMP).In this guidance, the term manufacturing is defined to include all operations of receipt
of materials, production, packaging, repackaging, labeling, relabeling, quality control,
release, storage and distribution of APIs and the related controls. In this guidance, the term
should identifies recommendations that, when followed, will ensure compliance with
CGMPs. An alternative approach may be used if such approach satisfies the requirements of
the applicable statutes. For the purposes of this guidance, the terms current good
manufacturing practices and good manufacturing practices are equivalent.

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This guidance is not intended to define registration and/or filing requirements or modify
pharmacopoeia requirements. This guidance does not affect the ability of the responsible
regulatory agency to establish specific registration/filing requirements regarding APIs within
the
context of marketing/manufacturing authorizations or drug applications. All commitments in
registration/filing documents should be met.
Within the world community, materials may vary as to their legal classification as an API.
When a material is classified as an API in the region or country in which it is manufactured
or used in a drug product, it should be manufactured according to this guidance.
This guidance applies to the manufacture of APIs for use in human drug (medicinal)
products.
It applies to the manufacture of sterile APIs only up to the point immediately prior to the
APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not
covered by this guidance, but should be performed in accordance with GMP guidance’s for
drug (medicinal) products as defined by local authorities. This guidance covers APIs that are
manufactured by chemical synthesis, extraction, cell culture/fermentation, recovery from
natural sources, or any combination of these processes. Specific guidance for APIs
manufactured by cell culture/fermentation is described in Section XVIII.
Responsibilities of the Quality Unit:-
The quality unit should be involved in all quality-related matters. The quality unit should
review and approve all appropriate quality-related documents. The main responsibilities of
the independent quality unit(s) should not be delegated.
These responsibilities should be described in writing and should include, but not necessarily
be limited to the following:
1. Releasing or rejecting all APIs. Releasing or rejecting intermediates for use
outside the control of the manufacturing company.
2. Establishing a system to release or reject raw materials, intermediates, packaging,
and labeling materials.

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3. Reviewing completed batch production and laboratory control records of critical
process steps before release of the API for distribution.
4. Making sure that critical deviations are investigated and resolved.
5. Approving all specifications and master production instructions.
6. Approving all procedures affecting the quality of intermediates or APIs.
7. Making sure that internal audits (self-inspections) are performed.
8. Approving intermediate and API contract manufacturers.
9. Approving changes that potentially affect intermediate or API quality.
10. Reviewing and approving validation protocols and reports.
11. Making sure that quality-related complaints are investigated and resolved.
12. Making sure that effective systems are used for maintaining and calibrating
critical equipment.
13. Making sure that materials are appropriately tested and the results are reported.
14. Making sure that there is stability data to support retest or expiry dates and storage
conditions on APIs and/or intermediates, where appropriate.
15. Performing product quality reviews.
1.6 Responsibility for Production Activities:-
The responsibility for production activities should be described in writing and should include,
but not necessarily be limited to:
1. Preparing, reviewing, approving, and distributing the instructions for the
production of intermediates or APIs according to written procedures.
2. Producing APIs and, when appropriate, intermediates according to pre-approved
instructions.
3. Reviewing all production batch records and ensuring that these are completed and
signed.
4. Making sure that all production deviations are reported and evaluated and that
critical deviations are investigated and the conclusions are recorded.
5. Making sure that production facilities are clean and, when appropriate, disinfected.
6. Making sure that the necessary calibrations are performed and records kept.
7. Making sure that the premises and equipment are maintained and records kept.
8. Making sure that validation protocols and reports are reviewed and approved.
9. Evaluating proposed changes in product, process or equipment.

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10. Making sure that new and, when appropriate, modified facilities and equipment are
qualified.
SOP For Disintegration Tester
1.0. PURPOSE:
To provide a procedure for operation of Disintegration tester.
2.0. SCOPE:
Applicable to Disintegration tester
MAKE & MODEL : Electrolab, ED-2AL
3.0. RESPONSIBILITY:
3.1. Officer-Quality Control
3.2. Executive-Quality Control
4.0. ACCOUNTABILITY:
Manager-Quality Control
5.0. DEFINITION:
Tablet disintegration testing is used as a quality-assurance measure. It is not a true predicter
of how well the dosage form will release its active ingredient in vivo. The United States
Pharmacopea (USP) sets standards for tablet disintegration testing. The apparatus is relatively
simple. It consists of a basket rack holding six plastic tubes open at the top and bottom. The
bottom is covered with a 10 mesh screen. The rack is immersed in a suitable liquid at 37
degrees C. It moves up and down at a specified rate. One tablet is placed into each tube and
the time to disintegrate and fall through the screen is noted.(see Ansel page 192)

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6.0. PROCEDURE:
6.1. Ensure the calibration status is valid and make sure that the instrument is clean and free
from dust.
6.2. Switch on the main switch and put on the ‘ON/OFF’ switch at the rear panel to ‘ ON’
position Follow the procedure to set the temperature.
6.3. For setting the temperature select the BATH probe by pressing PROBE key. This key
toggles between BATH probe EXTSEL
a) Press SET key – LED to the right of the key will glow.
b) Press TEMP key- Temperature display shows previous set temperature with right most
digit flashing.
c) Press ▲ key –Flashing digit value will show increment for every key press. OR
d) Press ▼ key - Flashing digit value will show decrement for every key press. Set the value
for flashing digit.
e) Press DISP key - Next significant digit flashes .Repeat the above step.
f) Repeat the step c & d till the desired temperature is set.
g) Press ENTER key –Set temperature value will be registered and SET LED will be off.
To confirm the set value of temperature, press SET key first and TEMP key next. See the set
value. Press ENTER key to come out from set mode.
NOTE: After pressing the SET key one should start the settings within 10 seconds other wise
the set mode will be terminated automatically.
Press the TEMP key to start temperature controller. The LED above TEMP key will start
glowing.
Select the bath temp indicator using PROBE SEL key. Once the bath temperature reaches the
set value , you are ready to start the test by pressing START/STOP key.
There are two modes of operation.
a) Timer mode b) Manual mode
a) Select mode by pressing TIMER key, if the TIMER LED is on, then timer mode is
selected. If the TIMER LED is off & Timer display shows “…….. then manual mode is
selected. TIMER key toggles between TIMER mode and MANUAL MODE.
In timer mode two time ranges are possible.
1) 1 sec to 99 min & 59 sec.

20
2) 1 min to 9 hrs & 59 min(if this range is selected the forth (left most) digit of timer display
will show “….”).For changing the timer range press SET key first and the ENTER key. Once
the test is started range cannot be altered. After range is selected now set the desired time as
mentioned. Step No 8.
Timer settings can be done only in timer mode. To set the timer follow the instructions given
below.
a. Press SET key- SET LED will start glowing.
b. Press TIMER key – Timer display shows last set value with right most digit flashing. To
set the digit go to step c
c. Press ▲ key –Flashing digit value will show increment for every key press.
OR
Press ▼ key - Flashing digit value will show decrement for every key
press. Set the value for flashing digit.
d. Press DISP SEL next significant digit will flash. Now repeat step c to set the value. Repeat
step d to set all digits. Press ENTER to accept the value .
e. Press ENTER key to complete the timer setting. Set LED goes off.
f. Start the test using START/STOP key. TIMER display shows the elapsed time starting
from “00.000” if the timer range is min , sec(“-0.00” if the timer range is hrs . min)
In any mode , to START or to STOP the test press the START/STOP key.
Warm distilled water to 37±2°C and take in 1000ml beaker. The volume of the water should
be such that the wire mesh of the moving basket at its highest point is at least 25mm below
the surface of the liquid and at its lowest point is atleast 25mm above the bottom of the
beaker.
Place the beaker in the disintegration test apparatus. Suspend the basket assembly in to the
beaker by fixing it in to the moving shaft.

21
Introduce one tablet in each of the six tubes of the basket of the assembly and place the disc
in each.
Press START/ STOP button and note the time.
Run the instrument for required period and switch off. Lift the basket and observe for
completion of disintegration.
Cleaning:
Empty the beaker and clean.
Remove the discs and clean the disintegration test apparatus.
7.0. REFERENCES: Instrument Manual
8.0. ENCLOSURES: Nil
9.0. ABBREVIATIONS: Nil
SOP for calibration
1.0.PURPOSE :
To provide a procedure for calibrating Disintegration tester.
2.0 SCOPE :
This covers the procedure for calibrating Disintegration tester ( QCI – 21 ).
MAKE & MODEL : Electrolab, ED-2L (USP).
3.0 RESPONSIBILITY :
QC officer.
4.0 PROCEDURE :

22
4.1 TEMPERATURE CHECK :
4.1.1 Keep about 800 ml of water in 1 liter beaker in the water bath.
4.1.2 Set the temperature to 37°C.
4.1.3 Wait until the set temperature reaches.
4.1.4 Observe and record the temperature,
Acceptance limit : 37°C ± 0.5°C.
4.2 STROKE HEIGHT:
4.2.1 Measure the distance between lowest and highest stroke,
Acceptance limit : 53mm to 57 mm.
4.3 CYCLES
4.3.1 Count the number of cycles per minute,
Acceptance limit : 28 – 32 cycles/minute.
5.0 FREQUENCY OF CALIBRATION :
Once in a month.

23
SOP for Operation of High Speed Centrifuges
1.0 OBJECTIVE
The goal of this SOP is to train personnel in the safe operation of high speed
centrifuges, both fixed rotor and swinging bucket rotor types. This SOP does not
apply to microcentrifuge units.
2.0 SCOPE
SOP applies to everyone who is working with centrifuges.
3.0 MATERIALS NEEDED
3.1.1 Centrifuge tubes and caps
3.1.2 Millipore water for balancing
3.1.3 Two pan balance
3.1.4 Sample
4.0 EQUIPMENT NEEDED
Centrifuge and Rotor
5.0 PROCEDURE
5.1 Identify the speed and duration at which you wish to centrifuge samples PRIOR to
using this instrument.
5.2 Check the rotor you intend to use and be certain that the rotor is rated for the speed at
which you would like to use it.
5.3 If the rotor is not capable of being operated at the target speed, you will need to
identify the rotor that is capable of being used at the desired speed, and then transfer your
samples to a centrifuge tube that will fit and rebalance the samples, remembering to include
the lids when balancing.

24
5.4 Place the rotor in the centrifuge with the 2 pins on the underside of the rotor forming a
cross with the 2 pins found on the spindle of the centrifuge. Check the name of the rotor and
confirm the target speed. Locate the correct lid for the selected rotor and place it beside the
centrifuge.
5.5 Place the samples into the rotor. If the samples do not all have the same mass, place
samples with the same mass on opposite sides of the rotor.
5.6 Once the samples are loaded, check the rotor type again, confirm that you have the
correct lid for the selected rotor and then screw the rotor lid onto the spindle.
5.7 The rotor lid set screw turns opposite to “normal” screws. Check for proper set screw
direction by looking at the diagram on the lid.
5.8 If this is a swinging bucket rotor, there is no lid.
5.9 Once the rotor lid is secured, close the centrifuge lid and set the desired temperature,
the desired speed and the desired spin time.
5.10 When everything is set, press the “Start” button and wait for the instrument to ramp
up to the desired speed.
5.10.1 It is normal to see a small vibration in the instrument as the speed moves from 100 to
2500 rpm.
5.11 Any large vibration in the instrument or irregular noise may indicate that something
has gone wrong with the run. Press the “Stop” button and move away from the instrument.
5.11.1 Immediately contact a faculty member who can assist you BEFORE you open the lid
to the centrifuge.
5.12 If no problems are detected as the instrument reaches the desired speed, you may
leave the area until the run is complete.

25
5.13 When the run has completed and the rotor has come to a complete stop, you may
unscrew the rotor lid and carefully remove your samples.
5.14 Should a sample vial have leaked during the run, you MUST IMMEDIATELY clean
the spill and dry the rotor.
5.14.1 It is easy to miss spilled liquids in the bottom of the positions of the rotor, however,
this liquid will cause an imbalance in the subsequent run that may lead to catastrophic failure.
5.15 Remove the rotor from the centrifuge and place in the appropriate box adjacent to the
unit.
5.15.1 If the rotor is a fixed angle rotor, put the lid on top of the rotor in the box.
5.16 Should a sample vial have leaked during the run, you MUST IMMEDIATELY clean
the spill and dry the rotor.
5.17 It is easy to miss spilled liquids in the bottom of the positions of the rotor, however,
this liquid will cause an imbalance in the subsequent run that may lead to catastrophic failure.
5.18 Clean the area around the centrifuge with 70% ethanol (denatured) and wipe dry.
5.18.1 This MUST be done following EVERY run. Failure to clean up after yourself may
ruin subsequent users’ experiments and/or facilitate the spread of contamination throughout
the department.
6.0 SAFETY
Wear gloves throughout the procedure. Do not leave the instrument

26
References
1. http://www.pharmatips.in/Articles/Pharmaceutical-Equipment/Tablet/Disintegration-
Tester-Operation-Calibration.aspx
2. https://www.kfu.edu.sa/ar/Colleges/clinical_pharmacy/Documents/Standard%20Oper
ating%20Procedures%20for%20Instruments%202012.pdf
3. https://www.pharmaguideline.com/2011/03/sop-for-operation-of-centrifuge-
machine.html
4. Quality Manual. Halifax Environmental Laboratory. Current version.
5. Guidance for the Preparation of Standard Operating Procedures. U.S. EPA. Current Version.
6. https://www.pharmaguideline.com/2011/09/sop-for-cleaning-of-dissolution-
tester.html
7. The Theory and practice of industrial pharmacy by Lachman.www.bioscreen.com.
8. Good manufacturing practices for pharmaceutical. A plan for total quality control by
willig.
9. Pharmaceutical ptoduct recall guidelines “Traders Licensing and Compliance
Division of Drug Office, Department of Health” 2017
10. Website of Globe pharm. The Advent of GMPs. Available from
11. Quality assurance of pharmaceuticals. A compendium of guidelines and related
materials; ‘Good manufacturing practices and inspection’. Updated edition. Vol 2.
Geneva: World Health Organization; 2004. pp. 58–85. Available from
http://whqlibdoc.who.int/publications/2004/9241546190.pdf
12. Schedule M Good Manufacturing Practices and Requirements of Premises, Plant and
Equipment for Pharmaceutical Products; The Drugs And Cosmetics Act And Rules
The Drugs And Cosmetics Act, 1940, (As Amended Up To The 30th June, 2005) And
The Drugs And Cosmetics Rules, 1945; (As Amended Up To The 30th June, 2005)
Available from:
http://www.cdsco.nic.in/html/DrugsandCosmeticAct.pdf
13. PIC/S Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-operation
Scheme “Guide to Good Manufacturing Practice for Medicinal Products PE 009-9
Part-I; September 2009. Available from
:http://www.picscheme.org/publication.php?id=4.
14. 10. Guidance for Industry: Manufacturing, Processing or Holding Active
Pharmaceutical Ingredient, Draft Guidance; USFDA, Centre for Drug Evaluation and
Research CDER March 1998

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