Quality Assurance &

Quality Control In
Pharma Industry
Dr. Basavaraj K. Nanjwade M.Pharm., Ph. D

Associate Professor of Pharmaceutics

Department of Pharmaceutics
KLE University, Belgaum – 590010, Karnataka, INDIA
E-mail: bknanjwade@yahoo.co.in
Cell No: 00919742431000
QA

GMP

QC
 QA
It is the sum total of the
organized arrangements
with the objective of
ensuring that products
will be of the quality
required for their
intended use
 GMP
Is that part of Quality
Assurance aimed at
ensuring that products
are consistently
manufactured to a
quality appropriate to
their intended use
 QC
Is that part of GMP
concerned with sampling,
specification & testing,
documentation & release
procedures which ensure
that the necessary &
relevant tests are
performed & the product
is released for use only
after ascertaining it‟s
quality
 QA and QC

• QA is the sum total of • QC is that part of GMP

organized which is concerned
arrangements made with sampling,
with the object of specifications, testing
ensuring that product and with in the
will be of the Quality organization,
required by their documentation,and
intended use. release procedures
which ensure that the
necessary and relevant
tests are carried out
 QA and QC
• All those planned • Operational
or systematic laboratory
actions necessary techniques and
to provide activities used to
adequate fulfill the
confidence that a requirement of
product will satisfy Quality
the requirements
for quality
 QA and QC

• QA is company • QC is lab based

based
 ESTABLISHING ACCEPTANCE CRITERION FOR A SPECIFIED IMPURITY IN A NEW
DRUG SUBSTANCE

Determine impurity level in

relevant batches1

Is
impurity also YES Estimate maximum increase in impurity
Determine mean + upper a at retest date using data from relevant
confidence degradation accelerated and long-term stability
limit for the impurity (Let this = A) product? studies

NO

Is
Acceptance criterion = A or NO A or B Determine maximum likely level as:
greater than the
B A + increase in degradation product at
qualified
(as appropriate) level? appropriate storage conditions.
(Let this = B)

YES

Acceptance criterion = qualified
level
or establish new qualified level2
1 Relevant batches are those from development, pilot and scale-up studies.
2 Refer to ICH Guideline on Impurities in New Drug Substances
Definition: upper confidence limit = three times the standard deviation of batch analysis data
 ESTABLISHING ACCEPTANCE CRITERION FOR A DEGRADATION PRODUCT IN A
NEW DRUG PRODUCT

Does Estimate maximum increase in

degradation NO degradation product at shelf life using
occur during product data from relevant accelerated and
manufacture? long-term stability studies.
(Let this = D)

YES

Determine maximum likely level as

Estimate maximum increase in degradation drug substance acceptance criterion2.
product during manufacture from relevant ((A or B) + C + D)
batches1. (Let this = C)

Is
maximum
NO likely level
greater
Acceptance criterion = maximum likely level. than the
qualified
level?

YES

Acceptance criterion = qualified

level
1 Relevant batches are those from development, pilot and scale-up studies. or establish new qualified level3
2 Refer to Decision Tree 1 for information regarding A and B. or new storage conditions
3 Refer to ICH Guideline on Impurities in New Drug Products.
or reduce shelf life.
SETTING ACCEPTANCE CRITERIA FOR DRUG SUBSTANCE PARTICLE SIZE
DISTRIBUTION

No drug substance particle

Is the drug product a solid
NO size acceptance criterion
dosage form or liquid
required for solution dosage
containing undissolved
forms.
drug substance?

YES

1. Is the particle size critical to dissolution,

solubility, or bioavailability?
2. Is the particle size critical to drug product
processability? If NO to all
3. Is the particle size critical to drug product stability?
4. Is the particle size critical to drug product
content uniformity?
5. Is particle size critical for maintaining
product appearance?

If YES to any

No Acceptance Criterion
Required

Set Acceptance Criterion

INVESTIGATING THE NEED TO SET ACCEPTANCE CRITERIA FOR POLYMORPHISM
IN DRUG SUBSTANCES AND DRUG PRODUCTS

Drug Substance

Conduct polymorphism Can NO

1. screen on drug substance. different polymorphs No further action
be formed?

YES

Characterize the forms:

e.g., - X-ray Powder 2.
GO TO
Diffraction
- DSC /
Thermoanalysis
- Microscopy
- Spectroscopy
INVESTIGATING THE NEED TO SET ACCEPTANCE CRITERIA FOR POLYMORPHISM
IN DRUG SUBSTANCES AND DRUG PRODUCTS

2.
Do the
forms have NO
different properties?
(solubility, stability,
melting point)

No further test or
YES acceptance criterion
for drug substance

Is drug
product safety, NO
performance or
efficacy affected?

YES

Set acceptance criterion

for polymorph content GO 3.
in drug substance TO
INVESTIGATING THE NEED TO SET ACCEPTANCE CRITERIA FOR POLYMORPHISM
IN DRUG SUBSTANCES AND DRUG PRODUCTS
Drug Product - Solid Dosage Form or Liquid Containing Undissolved Drug Substance
Undertake the following processes only if technically possible
to measure polymorph content in the drug product.
3.
Does
drug product
performance testing Establish acceptance criteria
YES
provide adequate control if for the relevant performance
polymorph ratio changes test(s).
(e.g., dissolution)?

NO

Monitor polymorph form during

stability of drug product.

Does a
change occur NO No need to set acceptance criteria
which could for polymorph change in drug
affect product.
safety or
efficacy?

YES

Establish acceptance criteria

which are consistent with
safety and/or efficacy.
 ESTABLISHING IDENTITY, ASSAY AND ENANTIOMERIC IMPURITY PROCEDURES
FOR CHIRAL NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS CONTAINING
CHIRAL DRUG SUBSTANCES

Consider the need for

Chiral identity, assay
verifying chiral identity in YES Is the new NO
and impurity
drug substance release drug substance
procedures
and/or acceptance AND RACEMIC chiral1?
are not needed.
testing.

YES
AND ONE ENANTIOMER

Needed for drug substance specification:2

-chiral identity3
-chiral assay4
-enantiomeric impurity5

Needed for drug product specification6:

-chiral assay4
-enantiomeric impurity5

1 Chiral substances of natural origin are not addressed in this Guideline.

2 Aswith other impurities arising in and from raw materials used in drug substance synthesis, control of chiral quality could be established alternatively by
applying limits to appropriate starting materials or intermediates when justified from developmental studies. This essentially will be the case when there
are multiple chiral centers (e.g., three or more), or when control at a step prior to production of the final drug substance is desirable.

3A chiral assay or an enantiomeric impurity procedure may be acceptable in lieu of a chiral identity procedure.

4 An achiral assay combined with a method for controlling the opposite enantiomer is acceptable in lieu of a chiral assay.

5 The level of the opposite enantiomer of the drug substance may be derived from chiral assay data or from a separate procedure.

6 Stereospecifictesting of drug product may not be necessary if racemization has been demonstrated to be insignificant during drug product manufacture
and during storage of the finished dosage form.
 MICROBIOLOGICAL QUALITY ATTRIBUTES OF DRUGS
SUBSTANCE AND EXCIPIENTS
NO
Is the drug substances/excipient Provide supporting data. Microbial
Capable of supporting microbial Limits acceptance criteria and testing
Growth or viability May not be necessary

YES
YES

Is the drug substances/excipient No further microbial limits testing or

Sterile? Acceptance criteria are necessary

NO
Establish microbial limit acceptance
Does drug substances/excipient YES criteria
Synthesis/processing involve As per the harmonized pharmacopeial
Steps which inherently monograph
Reduce microorganisms?

NO
Establish microbial limit acceptance
Criteria
As per the harmonized pharmacopoeial Does scientific evidence demonstrate that
monograph Reducation steps result in microorganism levels
<acceptance criteria limits (and the absence of
Compendial indicator organisms)
In the drug substance/excipient?
Are monitoring
Microorganism/indicator levels
Consistently below acceptance criteria
Levels?
YES
NO
YES NO Provide supporting data.
Microbial limits acceptace
Test lots on a skip-lot basis for Test each lot for microbial limits Criteria and testing
Microbial limits and freedom from and freedom from compendial May not be necessary
Compendial indicator organisms. indicator organisms.
SETTING ACCEPTANCE CRITERIA FOR DRUG PRODUCT DISSOLUTION
1 What type of drug release acceptance criteria are appropriate?
.
Is the dosage Establish drug release acceptance criteria.
YES
form designed to produce Extended release: multiple time points
modified release? Delayed release: two stages, parallel
or sequential

NO

Is drug solubility
at 37 ± 0.5°C high throughout
the physiological pH range?
(Dose/ solubility < 250 mL NO
(pH 1.2 - 6.8))

YES

Is dosage form
dissolution rapid?
NO Generally single-point dissolution
(Dissolution > 80% in 15 minutes acceptance criteria with a lower limit
at pH 1.2, 4.0, and 6.8) are acceptable.

YES

NO

Has a relationship been

Generally disintegration acceptance
determined between disintegration
YES criteria with an upper time
and dissolution?
limit are acceptable.

Continued on next page.

SETTING ACCEPTANCE CRITERIA FOR DRUG PRODUCT DISSOLUTION

2. What specific test conditions and acceptance criteria are appropriate? [immediate release]

Does
dissolution significantly
affect bioavailability? YES Attempt to develop test conditions and acceptance
(e.g., have relevant developmental criteria which can distinguish batches
batches exhibited unacceptable with unacceptable bioavailability.
bioavailability?)

NO

Do changes in
formulation or
manufacturing variables
YES Are these changes controlled
affect dissolution?
by another procedure and acceptance
(Use appropriate ranges.
criterion?
Evaluate dissolution
within pH 1.2 - 6.8)

YES
NO
NO

Adopt appropriate test conditions

and acceptance criteria without
regard to discriminating power, to
Adopt test conditions and acceptance criteria
pass clinically acceptable batches.
which can distinguish these changes.
Generally, single point acceptance criteria
are acceptable.
SETTING ACCEPTANCE CRITERIA FOR DRUG PRODUCT DISSOLUTION

3. What are appropriate acceptance ranges? [extended release]

Are bioavailability
NO
data available for batches Is drug release independent of
with different drug release rates? in vitro test conditions?

YES
YES

NO

Can an in vitro / in vivo

Use all available stability, clinical, and
relationship be established? NO
bioavailability data to establish
appropriate acceptance ranges.
(Modify in vitro test
conditions
if appropriate.)

YES

Use the in vitro / in vivo Are acceptance Provide appropriate

correlation, along with
appropriate batch data, to
establish acceptance ranges.
ranges >20% of the YES
bioavailability data
labeled content?
to validate the
acceptance ranges.

NO

Finalize acceptance
ranges.
 MICROBIOLOGICAL ATTRIBUTES OF NON-STERILE
DRUGS PRODUCTS
No Does the drug product contain
YES
Antimicrobial preservatives or possess
Inherent antimicrobial
activity

Establish preservative chemical acceptance criteria and

Perform preservative effectiveness validation of product
Containing less than or equal to the minimum specifie
Is the drug product a dry dosage form Preservative concentration, or demonstrate the inherent
(e.g. solid oral or dry powder)? Antimicrobial activity of the drug product.
No

YES Establish microbial limit acceptance criteria

As per the harmonized pharmacopoeia
No Monograph.

Does scientific evidence demonstrate

Growth inhibitory properties of the
Drug product? Perform microbial limits testing on a
Lot-by-lot basis.

YES No

Microbial limits acceptance criteria and testing

May not be necessary Do production lots consistently meet
Microbial limits acceptance criteria?

YES

Perform skip-lot testing for microbial

Limits, or provide scientific justification for
no routine microbial limits testing.
 ICH Harmonised Tripartite Guideline

• Stability Testing of New Drug Substances and Products

• Stability Testing: Photostability Testing of New Drug

Substances and Products

• Stability Testing for New Dosage Forms

• Bracketing and Matrixing Designs for Stability Testing of

New Drug Substances and Products

• Evaluation for Stability Data

• Stability Data Package for Registration Applications in

Climatic Zones III and IV

• Validation of Analytical Procedures: Text and Methodology

• Impurities In New Drug Substances

 ICH Harmonised Tripartite Guideline

• Impurities in New Drug Products

• Impurities: Guideline for Residual Solvents

• Evaluation and Recommendation of Pharmacopoeial

Texts for Use in the ICH Regions on Microbiological
Examination of Non-Sterile Products: Microbial
Enumerations Tests

• Evaluation and Recommendation of Pharmacopoeial

Texts for Use in the ICH Regions on Microbiological
Examination of Non-Sterile Products: Test for
Specified Micro-Organisms
 ICH Harmonised Tripartite Guideline

• Evaluation and Recommendation of Pharmacopoeial

Texts for Use in the ICH Regions on Microbiological
Examination of Non-Sterile Products: Acceptance
Criteria for Pharmaceutical Preparations and
Substances for Pharmaceutical Use

• Evaluation and Recommendation of Pharmacopoeial Texts

for Use in the ICH Regions on Residue on
Ignition/Sulphated Ash

• Evaluation and Recommendation of Pharmacopoeial

Texts for Use in the ICH Regions on Test for
Extractable Volume of Parenteral Preparations
 ICH Harmonised Tripartite Guideline

• Evaluation and Recommendation of Pharmacopoeial

Texts for Use in the ICH Regions on Test for
Particulate Contamination: Sub-Visible Particles

• Evaluation and Recommendation of Pharmacopoeial

Texts for Use in the ICH Regions on Disintegration

• Evaluation and Recommendation of Pharmacopoeial

Texts for Use in the ICH Regions on Uniformity of
Dosage Units

• Evaluation and Recommendation of Pharmacopoeial

Texts for Use in the ICH Region on Dissolution Test
 ICH Harmonised Tripartite Guideline

• Evaluation and Recommendation of Pharmacopoeial

Texts for Use in the ICH Regions on Sterility Test

• Evaluation and Recommendation of Pharmacopoeial

Texts for Use in the ICH Regions onTablet Friability

• Evaluation and Recommendation of Pharmacopoeial

Texts for Use in the ICH Regions on Polyacrylamide
Gel Electrophoresis

• Viral Safety Evaluation of Biotechnology Products

Derived from Cell Lines of Human or Animal Origin
 ICH Harmonised Tripartite Guideline

• Quality of Biotechnological Products: Analysis of the

Expression Construct in Cells used for Production of r-DNA
Derived Protein Products

• Quality of Biotechnological Products: Stability Testing of

Biotechnological/Biological Products

• Derivation and Characterisation of Cell Substrates Used for

Production of Biotechnological/Biological Products

• Comparability of Biotechnological/Biological Products

Subject to Changes in their Manufacturing Process

• Specifications: Test Procedures and Acceptance Criteria for

New Drug Substances and New Drug Products: Chemical
Substances
 ICH Harmonised Tripartite Guideline
• Specifications: Test Procedures and Acceptance
Criteria for Biotechnological/Biological Products

• Good Manufacturing Practice Guide for Active

Pharmaceutical Ingredients

• Pharmaceutical Development

• Quality Risk Management

• Pharmaceutical Quality System

• Quality Implementation Working Group

Quality Assurance (QA) Management
Procedure
 How to write Standard Operating
Procedure

• SOP describes standard SOP format

that you can use immediately for
your quality procedure.

• SOP has instructions on how to write

a formal operating procedure for
your systems which your people can
follow everyday.
 All Documents-Classifications,
Definition and Approval Matrix

• In this SOP you will find all type of quality

and Technical/Master file documents to
build up a good quality management
system for your manufacturing sites,
definition of documents, their
classification, approval requirements and
retention requirements.

• This procedure has schematic diagrams

for your understanding of how different
types of documents are prepared and
stored in a typical documentation.
 Quality Documentation Management
and Change Control
• This SOP describes how to generate new
quality documents or change control of
existing documents, review of quality
documents, satellite file management, role
of document author, approver, document
control officer and satellite file
administrator.

• In this SOP you will also find numbering

systems of different quality documents
like audit files, SOP‟s, forms, manuals,
training files, QA agreements, project files
etc and their effective archiving system.
 Documentation Rule for GMP
Documents

• This SOP describes the principles to

be followed in GMP documents, entry
of data and information, signature
requirements and correction
technique of incorrectly entered data
or information.
 Quality Documentation-Control,
Tracking and Distribution

• In this SOP you will find mainly the role of

document control officer during the initiation,
creation, circulation and approval of new quality
related documents.

• It also describes the procedure of modification

and review of existing document using a
documentation database.

• Management of existing and superseded

documents is also a art of this procedure.

• You will see all the forms referred during the

instruction are attached at the end of the
procedure.
 Preparation, Maintenance and
Change Control of Master Documents
• This SOP particularly focused on the management
of master file documents like specifications,
control methods, raw materials, finished goods
and packaging specification and test reports,
formulation, stability files etc required to
generate during the product registration in the
market.

• This SOP gives instruction on their creation,

change control, numbering system, approval
requirements and maintenance in a simple
master file database.

• You will see all the forms referred during the

instruction are attached at the end of the
procedure.
 Deviation Report System
• It is a regulatory requirement to capture all sorts
of deviations evolves in your systems in order to
maintain the continuous improvement to your
processes and systems.

• This SOP describes how to categorize the

deviations between production, audit, quality
improvements, technical deviations, customer
complaints and environmental, health and safety
deviations.

• It describes the management responsibilities of

initiating deviation, capture data, analysis,
investigation, determination of assignable causes,
generation of management report and initiatives
to be taken on corrective and preventative
actions.
 Shelf Life of Product

• This simple SOP describes the

meaning of shelf life and provides on
how to interpret shelf lives and
storage conditions for your raw
materials from the Certificate of
Analysis, determining expiry date for
your finished products by use of raw
material date of manufacturing and
their shelf lives.
 Vendor Selection and Evaluation

• This SOP describes the procedure to be

followed during the vendor assessment
and vendor evaluation for purchasing of
raw materials, critical and non critical
packaging components, laboratory
supplies, engineering supplies and
imported finished goods from the vendor.

• These instructions are essential for

approving prospective vendor.
 Vendor Certification

• This procedure aim to describe the

process by which a vendor may be
certified to supply materials or services.

• This procedure applies to vendors that

supply a material or service to be used at
any stage of manufacture by operations.

• Here you will get the roles of each

department in the process to certify an
approved vendor.
 Product Complaint Procedure

• This procedure covers the receipt, logging,

evaluation, investigation and reporting system of
all complaints received from customers for the
marketed products.

• This SOP contains step by step instruction to be

followed in the customer complaint management
like numbering of complaint, registration,
evaluation of complaints, determination of
assignable cause for the complaint deviation,
implementation of corrective and preventive
actions, trending of complaints and handling of
counterfeit products.
 Annual Product Review

• This procedure provides a guideline

to annual product review which is
required to be performed for each
product produced for the commercial
market to evaluate data, trends and
to identify any preventative or
corrective action that would lead to
product quality improvements and
report them to management.
 Rework Procedure

• This SOP contains the step by step instruction to

be followed when the rework of an in-process or
completed finished good is required.

• This SOP covers the reworks of in-process

manufactured goods where new batch number is
introduced for the reworked part and rework of
manufactured finished good keeping the same
batch number.

• This SOP also describes how to create rework

protocols for each individual case.
 Authorized Person

• This simple procedure describes the

accreditation, accountabilities and
responsibilities of an Authorized
person, responsible for release of
finished goods for sale.
 Product Identification and
Traceability

• The purpose of this SOP is to define the

method used for the identification of all
contributing materials that could affect
product quality and to ensure their full
traceability.

• Here you will find instruction on all the

records and documents used for the
identification and traceability of incoming
raw materials and out going finished
goods.
 Audits

• This SOP describes the process of

planning, performing, reporting and
follow-up of different audits for your
systems like Internal Quality audit, Vendor
audit, Environmental Health and Safety
(EHS) audit, EHS workplace inspection,
Housekeeping audit.

• This SOP also describes the process to be

followed by manufacturing personnel
during an audit from a Regulatory
authority.
 Example-Checklist for Batch Documentation

• This SOP describes the identification of all

documentation relevant to a production
process in the form of “Batch
Documentation Checklists” and to ensure
their collection by completion of the
checklists by Authorized Persons.

• This procedure is based on an example of

tablet packaging process described in the
„Manufacturing‟ category.
 Evaluation of Batch Documentation
and Release for Sale

• This procedure describes the process of

collection, evaluation and record of batch
related document generated during the
production of a batch before an authorized
person can release the batch for sale.

• This procedure is based on an example of

tablet packaging process described in the
„Manufacturing‟ category.
 GMP Training

• This SOP describes how to design

and deliver GMP related training for
your manufacturing staffs, training
assessment design, recording of
assessment and preparation of
training reports.
 How to Write Training Materials

• This simple SOP contains instructions

on how to write training materials,
identification of training
requirements, available resources,
preparation of training aid checklists
for your manufacturing staffs.
 House Keeping Audit Procedure

• This SOP describes the requirements, checklists

and reporting procedure on housekeeping audits.

• Individual checklist forms are attached at end of

the procedure for different areas like process,
laboratory, engineering stores, warehouses.

• This procedure also describes the handling of

non-compliance found during the housekeeping
audits.
 Management and Control of Contract Work

• The procedure describes the

management and control of contract
work provided by the contractors for
packaging and finished products for
your company as well as control of
contract works done by your
company on behalf of others.
 Criteria for Sourcing of RM, Critical
Packaging Components and Imported
Finishing Goods
• The purpose of this SOP is to describe the
process for approval of an external
vendor/manufacturer supplying products to your
company.

• It covers raw materials (including bulk products

for subsidiaries and contract manufacturers),
critical packaging components in contact with
product and imported finished goods.

• The SOP also references affiliated documentation

detailing the scope of active materials used and
the approved manufacturers of these materials.
 Quality Concern Investigation
Process

• This procedure contains instruction to be followed

when conducting Investigations and to raise and
assess Deviation Report when an investigation or
incident Investigation occurs.

• This procedure is to be used in conjunction with

SOP, which covers the approval and follow-up
activities associated with a Deviation Report.

• Here you will find collection of information for an

incident or a deviation, steps to be followed for a
cross functional investigation, reporting and
implementing of the outcomes of investigation.
Quality Control Laboratory
Procedures
 Retest Dating of Raw Materials

• The purpose of this procedure is to

describe how to run the expired stock
report; to describe how to define the
requirements for the retesting and
assignment of storage period for active
ingredients, excipients and raw materials;
to instruct retesting procedure and to
determine the status of a finished goods
batch with a shorter shelf life.
 Calibration Policies for Laboratory
Instruments

• This SOP describes the calibration polices

of laboratory instruments/equipments.

• It describes labeling and security

requirements of laboratory
instruments/equipments.

• This SOP also describes the investigational

steps to be required in the case of failed
calibration
 Archiving Laboratory Documentation

• This procedure describes retention and

disposal procedures of laboratory
documentation, general laboratory
documentation system that includes
handling of rejected raw material and
finished product reports, finished goods
certificate of analysis, finished goods
register, raw material certificate of
analysis, register, trend cards, procedure
for long term document retention.
 Management of Reference
Substances

• This SOP describes the ordering

referencing, storing, coding, use and
general register maintenance of primary
and impurity reference substances,
primary reagent reference solutions,
secondary raw material reference
substance, assay testing procedure of
secondary raw material reference
substance, use of secondary raw material
reference substance in the laboratory
routine analysis, determination of expiry
date and re-test date of reference
substances.
 Laboratory Workbook

• This SOP describes types of laboratory

workbooks, general and GMP
requirements of using workbooks,
analytical data entry in the workbook,
formatting of laboratory workbooks for
routine testing, experiments and trials,
workbook retention policy, instruction on
data entry for incomplete experiments and
additional data.
 Creation of Certificate of Analysis

• The purpose of this procedure is to

define the content and format of a
Certificate of Analysis (C/A) and
Certificate of Manufacture (C/M) and
to provide guidance for issuing a
Certificate of Analysis or Certificate
of Manufacture and to locate the
appropriate data required for this
task.
 Managing Analytical Reagents

• This procedure identifies the need for all

analytical reagents and solutions prepared
from the reagents, to have an assigned
expiry date and storage conditions
recorded on the label.

• Here you will find the procedure for

purchase and management of analytical
reagents and laboratory prepared
reagents.
 Laboratory Waste Management

• This simple procedure describes how

to dispose off laboratory generated
wastes of toxic, explosive, flammable,
corrosive, oxidizing and biologically
damaging natures.
 Retention Samples-Laboratory

• The purpose of this SOP is to

describe the finished good and raw
material sample retention
procedures, products manufacture
and/or received onsite and/or
chemically tested by the laboratory.
 Laboratory Supplier Approval

• In this simple SOP you will find the

procedure for approving laboratory
suppliers and criteria for the
purchase of equipment,
instrumentation, consumables,
durables and glassware for the
laboratory.
 Laboratory Results-Out of Specification
Investigation

• This procedure describes the actions to be taken

by an analyst in the event the result of a test
does not conform to raw material/components or
finished products specifications for physical and
chemical tests.

• An out of specification (OOS) result does not

necessarily mean the batch under investigation
fails and shall be rejected.

• The OOS result shall be investigated and the

findings of the investigation, including re-test
results shall be interpreted to evaluate the batch
and reach a decision regarding release or
rejection.
 Raw Materials-Laboratory Testing
and Documentation

• This SOP describes the procedure for

sampling, location, pre-testing,
testing and documentation of all raw
materials and components subject to
test, out of specification results,
microbiological tests and release
procedure for passed raw materials
and components.
 Finished Goods-Laboratory Testing and
Documentation

• This SOP describes the procedure for

sampling, location, pre-testing,
testing and documentation of all
finished products subject to test,
reagents and standards to be used
for analysis, management of out of
specification results, microbiological
tests and release procedure for
passed finished goods.
 Preparation and Maintenance of
Stability Protocols (Pharmaceuticals)

• This procedure describes the preparation and

management of stability protocols for marketed
products.

• This procedure is applicable to all protocols for

stability studies on commercial products.

• The responsibility of the commercial Site stability

manager for creating and maintaining protocols
that are required for studies that came as a
result of validation or process deviation.
 Stability and Trial Testing Procedure
(Pharmaceuticals)

• To describes the steps necessary to ensure the

effective control of stability and trial testing
programs of new and existing products.

• This procedure is focused on setting up of

stability programs, testing, reporting, general
sampling procedure for stability programs, data
generation and analysis, annual maintenance of
stability, new product stability procedure,
procedure for in-house trials, reporting and
interpretation of trials and conclusion of the trail
program.
 REFERENCES
• www.ich.org
• www.fda.gov
THANK YOU
E-mail: bknanjwade@yahoo.co.in Cell No: 00919742431000