Quality Assurance in Pharmaceuticals

Quality AssuranceQuality Assurance && QualityQuality
ControlControl In Pharma IndustryIn Pharma Industry

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
QA

Is that part of Quality
Assurance aimed at
ensuring that products
are consistently
manufactured to a
quality appropriate to
their intended use
GMP

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
QC

QAQA andand QCQC
• QC is that part of GMP
which is concerned with
sampling,
specifications, testing
and with in the
organization,
documentation,and
release procedures
which ensure that the
necessary and relevant
tests are carried out
• QA is the sum total of
organized
arrangements made
with the object of
ensuring that product
will be of the Quality
required by their
intended use.

QAQA andand QCQC
• Operational
laboratory
techniques and
activities used to
fulfill the
requirement of
Quality
• All those planned
or systematic
actions necessary
to provide
adequate
confidence that a
product will satisfy
the requirements
for quality

QAQA andand QCQC
• QC is lab based• QA is company
based

Determine impurity level in
relevant batches1
Acceptance criterion = A or
B
(as appropriate)
Is
impurity also
a
degradation
product?
Is
A or B
greater than the
qualified
level?
Acceptance criterion = qualified
level
or establish new qualified level2
Estimate maximum increase in impurity
at retest date using data from relevant
accelerated and long-term stability
studies
Determine maximum likely level as:
A + increase in degradation product at
appropriate storage conditions.
(Let this = B)
YES
YES
NO
NO
ESTABLISHING ACCEPTANCE CRITERION FOR A SPECIFIED IMPURITY IN A
NEW
DRUG SUBSTANCE
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
Determine mean + upper
confidence
limit for the impurity (Let this = A)

Does
degradation
occur during product
manufacture?
Estimate maximum increase in
degradation product at shelf life using
data from relevant accelerated and
long-term stability studies.
(Let this = D)
Determine maximum likely level as
drug substance acceptance criterion2
.
((A or B) + C + D)
Is
maximum
likely level greater
than the
qualified
level?
Estimate maximum increase in degradation
product during manufacture from relevant
batches1
. (Let this = C)
Acceptance criterion = maximum likely level.
Acceptance criterion = qualified
level
or establish new qualified level3
or new storage conditions
or reduce shelf life.
NO
NO
YES
YES
ESTABLISHING ACCEPTANCE CRITERION FOR A DEGRADATION PRODUCT IN A
NEW DRUG PRODUCT
1
Relevant batches are those from development, pilot and scale-up studies.
2
Refer to Decision Tree 1 for information regarding A and B.
3
Refer to ICH Guideline on Impurities in New Drug Products.

Is the drug product a solid
dosage form or liquid
containing undissolved
drug substance?
No drug substance particle
size acceptance criterion
required for solution dosage
forms.
1. Is the particle size critical to dissolution,
solubility, or bioavailability?
2. Is the particle size critical to drug product
processability?
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?
Set Acceptance Criterion
No Acceptance Criterion
Required
If YES to any
If NO to all
NO
YES
SETTING ACCEPTANCE CRITERIA FOR DRUG SUBSTANCE PARTICLE SIZE
DISTRIBUTION

INVESTIGATING THE NEED TO SET ACCEPTANCE CRITERIA FOR
POLYMORPHISM
IN DRUG SUBSTANCES AND DRUG PRODUCTS
Drug Substance
1.
2.
NO
YES
Conduct polymorphism
screen on drug substance. No further action
Can
different polymorphs
be formed?
GO TO
Characterize the forms:
e.g., - X-ray Powder
Diffraction
- DSC /
Thermoanalysis
- Microscopy
- Spectroscopy

POLYMORPHISM
2.
3.GO TO
NO
NO
YES
Do the
forms have
different properties?
(solubility, stability,
melting point)
Is drug
product safety,
performance or
efficacy affected?
No further test or
acceptance criterion
for drug substance
YES
Set acceptance criterion
for polymorph content
in drug substance

POLYMORPHISM
3.
YES
NO
NO
YES
Does
drug product
performance testing
provide adequate control if
polymorph ratio changes
(e.g., dissolution)?
Establish acceptance criteria
for the relevant performance
test(s).
Monitor polymorph form during
stability of drug product.
No need to set acceptance criteria
for polymorph change in drug
product.
Does a
change occur
which could
affect
safety or
efficacy?
Establish acceptance criteria
which are consistent with
safety and/or efficacy.
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.

ESTABLISHING IDENTITY, ASSAY AND ENANTIOMERIC IMPURITY PROCEDURES
FOR CHIRAL NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS CONTAINING
CHIRAL DRUG SUBSTANCES
YES
AND RACEMIC
Consider the need for
verifying chiral identity in
drug substance release
and/or acceptance
testing.
Is the new
drug substance
chiral1
?
Chiral identity, assay
and impurity
procedures
are not needed.
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
NO
1
Chiral substances of natural origin are not addressed in this Guideline.
2
As with 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.
3
A 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
Stereospecific testing 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 DRUGSMICROBIOLOGICAL QUALITY ATTRIBUTES OF DRUGS
SUBSTANCE AND EXCIPIENTSSUBSTANCE AND EXCIPIENTS
Is the drug
substances/excipient
Capable of supporting microbial
Growth or viability
Is the drug substances/excipient
Sterile?
Does drug
substances/excipient
Synthesis/processing involve
Steps which inherently
Reduce microorganisms?
Establish microbial limit acceptance
Criteria
As per the harmonized pharmacopoeial
monograph
Are monitoring
Microorganism/indicator levels
Consistently below acceptance criteria
Levels?
Test lots on a skip-lot basis for
Microbial limits and freedom from
Compendial indicator organisms.
Test each lot for microbial limits
and freedom from compendial
indicator organisms.
Provide supporting data. Microbial
Limits acceptance criteria and
testing
May not be necessary
No further microbial limits testing or
Acceptance criteria are necessary
Establish microbial limit acceptance
criteria
As per the harmonized pharmacopeial
monograph
Does scientific evidence demonstrate that
Reducation steps result in microorganism levels
<acceptance criteria limits (and the absence of
Compendial indicator organisms)
In the drug substance/excipient?
Provide supporting data.
Microbial limits acceptace
Criteria and testing
YES
YES
YES
YES
YES NO
NO
NO
NO
NO

1
.
What type of drug release acceptance criteria are appropriate?
Is the dosage
form designed to produce
modified release?
YES
Establish drug release acceptance criteria.
Extended release: multiple time points
Delayed release: two stages, parallel
or sequential
Is drug solubility
at 37 ± 0.5°C high throughout
the physiological pH range?
(Dose/ solubility < 250 mL
(pH 1.2 - 6.8))
NO
Continued on next page.
Generally single-point dissolution
acceptance criteria with a lower limit
are acceptable.
Is dosage form
dissolution rapid?
(Dissolution > 80% in 15 minutes
at pH 1.2, 4.0, and 6.8)
Has a relationship been
determined between disintegration
and dissolution?
Generally disintegration acceptance
criteria with an upper time
limit are acceptable.
YES
NO
YES
YES
NO
NO
SETTING ACCEPTANCE CRITERIA FOR DRUG PRODUCT DISSOLUTION

2. What specific test conditions and acceptance criteria are appropriate? [immediate release]
Does
dissolution significantly
affect bioavailability?
(e.g., have relevant developmental
batches exhibited unacceptable
bioavailability?)
Attempt to develop test conditions and acceptance
criteria which can distinguish batches
with unacceptable bioavailability.
YES
NO
YES
NO
YES
NO
Do changes in
formulation or
manufacturing variables
affect dissolution?
(Use appropriate ranges.
Evaluate dissolution
within pH 1.2 - 6.8)
Are these changes controlled
by another procedure and acceptance
criterion?
Adopt appropriate test conditions
and acceptance criteria without
regard to discriminating power, to
pass clinically acceptable batches.
Adopt test conditions and acceptance criteria
which can distinguish these changes.
Generally, single point acceptance criteria
are acceptable.

3.
YES
NO
NO
YES
YES
NO
YES
NO
Are bioavailability
data available for batches
with different drug release rates?
Is drug release independent of
in vitro test conditions?
Can an in vitro / in vivo
relationship be established?
(Modify in vitro test
conditions
if appropriate.)
Use all available stability, clinical, and
bioavailability data to establish
appropriate acceptance ranges.
Use the in vitro / in vivo
correlation, along with
appropriate batch data, to
establish acceptance ranges.
Are acceptance
ranges >20% of the
labeled content?
Provide appropriate
bioavailability data
to validate the
acceptance ranges.
Finalize acceptance
ranges.
What are appropriate acceptance ranges? [extended release]

MICROBIOLOGICAL ATTRIBUTES OF NON-STERILEMICROBIOLOGICAL ATTRIBUTES OF NON-STERILE
DRUGS PRODUCTSDRUGS PRODUCTS
Does the drug product contain
Antimicrobial preservatives or possess
Inherent antimicrobial
activity
Is the drug product a dry dosage form
(e.g. solid oral or dry powder)?
Does scientific evidence demonstrate
Growth inhibitory properties of the
Drug product?
Microbial limits acceptance criteria and testing
Establish preservative chemical acceptance criteria and
Perform preservative effectiveness validation of product
Containing less than or equal to the minimum specifie
Preservative concentration, or demonstrate the inherent
Antimicrobial activity of the drug product.
Establish microbial limit acceptance criteria
As per the harmonized pharmacopoeia
Monograph.
Perform microbial limits testing on a
Lot-by-lot basis.
Do production lots consistently meet
Microbial limits acceptance criteria?
Perform skip-lot testing for microbial
Limits, or provide scientific justification for
no routine microbial limits testing.
No
No
No
No
YES
YES
YES
YES

Pharmaceuticals Quality Assurance

ICH Harmonised Tripartite GuidelineICH 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

• 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
Examination of Non-Sterile Products: Test for
Specified Micro-Organisms

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

Texts for Use in the ICH Regions on Test for
Particulate Contamination: Sub-Visible Particles
Texts for Use in the ICH Regions on Disintegration
Texts for Use in the ICH Regions on Uniformity of
Dosage Units
Texts for Use in the ICH Region on Dissolution Test

Texts for Use in the ICH Regions on Sterility Test
Texts for Use in the ICH Regions onTablet Friability
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

• 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

• 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 OperatingHow to write Standard Operating
ProcedureProcedure
• 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,All Documents-Classifications,
Definition and Approval MatrixDefinition 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 ManagementQuality Documentation Management
and Change Controland 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 GMPDocumentation Rule for GMP
DocumentsDocuments
• 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,Quality Documentation-Control,
Tracking and DistributionTracking 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 andPreparation, Maintenance and
Change Control of Master DocumentsChange 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 SystemDeviation 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 ProductShelf 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 EvaluationVendor 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 CertificationVendor 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 ProcedureProduct 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 ReviewAnnual 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 ProcedureRework 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 PersonAuthorized Person
• This simple procedure describes the
accreditation, accountabilities and
responsibilities of an Authorized
person, responsible for release of
finished goods for sale.

Product Identification andProduct Identification and
TraceabilityTraceability
• 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.

AuditsAudits
• 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 DocumentationExample-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 DocumentationEvaluation of Batch Documentation
and Release for Saleand 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 TrainingGMP 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 MaterialsHow 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 ProcedureHouse 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 WorkManagement 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, CriticalCriteria for Sourcing of RM, Critical
Packaging Components and ImportedPackaging Components and Imported
Finishing GoodsFinishing 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 InvestigationQuality Concern Investigation
ProcessProcess
• 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 MaterialsRetest 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 LaboratoryCalibration Policies for Laboratory
InstrumentsInstruments
• 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 DocumentationArchiving 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 ReferenceManagement of Reference
SubstancesSubstances
• 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 WorkbookLaboratory 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 AnalysisCreation 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 ReagentsManaging 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 ManagementLaboratory 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-LaboratoryRetention 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 ApprovalLaboratory 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 SpecificationLaboratory Results-Out of Specification
InvestigationInvestigation
• 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 TestingRaw Materials-Laboratory Testing
and Documentationand 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 andFinished Goods-Laboratory Testing and
DocumentationDocumentation
• 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 ofPreparation and Maintenance of
Stability Protocols (Pharmaceuticals)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 ProcedureStability and Trial Testing Procedure
(Pharmaceuticals)(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.

REFERENCESREFERENCES
• www.ich.org
• www.fda.gov

Quality Assurance in Pharmaceuticals

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