Quality Assurance & Quality Control In Pharma Industry

1
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_at_yahoo.co.in
• Cell No 00919742431000

2
QA
GMP
QC
3

• 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
4

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

GMP
5

• 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 its
  quality

QC
6
QA and QC

• 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.

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QA and QC

• 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

8
QA and QC

• QC is lab based

• QA is company based

9
ESTABLISHING ACCEPTANCE CRITERION FOR A SPECIFIED
IMPURITY IN A NEW DRUG SUBSTANCE
Determine impurity level in relevant batches1
Isimpurity alsoa degradationproduct?
Estimate maximum increase in impurityat retest
date using data from relevantaccelerated and
long-term stability studies
YES
Determine mean upper confidence limit for the
impurity (Let this A)
NO
IsA or B greater than thequalifiedlevel?
Acceptance criterion A or B(as appropriate)
Determine maximum likely level asA increase
in degradation product atappropriate storage
conditions.(Let this B)
NO
YES
1 Relevant batches are those from development,
pilot and scale-up studies. 2 Refer to ICH
Guideline on Impurities in New Drug
SubstancesDefinition upper confidence limit
three times the standard deviation of batch
analysis data
Acceptance criterion qualified levelor
establish new qualified level2
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ESTABLISHING ACCEPTANCE CRITERION FOR A
DEGRADATION PRODUCT IN A NEW DRUG PRODUCT
Doesdegradationoccur during productmanufacture?
Estimate maximum increase in degradation product
at shelf life usingdata from relevant
accelerated andlong-term stability studies.
(Let this D)
NO
YES
Determine maximum likely level as drug substance
acceptance criterion2.((A or B) C D)
Estimate maximum increase in degradationproduct
during manufacture from relevantbatches1. (Let
this C)
Ismaximum likely level greaterthan
thequalifiedlevel?
NO
Acceptance criterion maximum likely level.
YES
Acceptance criterion qualified levelor
establish new qualified level3or new storage
conditions or reduce shelf life.
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.
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SETTING ACCEPTANCE CRITERIA FOR DRUG SUBSTANCE
PARTICLE SIZE DISTRIBUTION
No drug substance particlesize acceptance
criterion required for solution dosage forms.
Is the drug product a soliddosage form or liquid
containing undissolveddrug substance?
NO
YES
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?
If NO to all
If YES to any
No Acceptance Criterion Required
Set Acceptance Criterion
12
INVESTIGATING THE NEED TO SET ACCEPTANCE CRITERIA
FOR POLYMORPHISMIN DRUG SUBSTANCES AND DRUG
PRODUCTS
Drug Substance
NO
Conduct polymorphismscreen on drug substance.
Candifferent polymorphsbe formed?
1.
No further action
YES
Characterize the formse.g., - X-ray Powder
Diffraction - DSC / Thermoanalysis
- Microscopy - Spectroscopy
2.
GO TO
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INVESTIGATING THE NEED TO SET ACCEPTANCE CRITERIA
FOR POLYMORPHISMIN DRUG SUBSTANCES AND DRUG
PRODUCTS
2.
Do theforms havedifferent properties?(solubilit
y, stability,melting point)
NO
No further test oracceptance criterionfor drug
substance
YES
Is drugproduct safety,performance or efficacy
affected?
NO
YES
Set acceptance criterionfor polymorph contentin
drug substance
3.
GO TO
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INVESTIGATING THE NEED TO SET ACCEPTANCE CRITERIA
FOR POLYMORPHISMIN DRUG SUBSTANCES AND DRUG
PRODUCTS
Drug Product - Solid Dosage Form or Liquid
Containing Undissolved Drug Substance
Undertake the following processes only if
technically possibleto measure polymorph content
in the drug product.
3.
Doesdrug productperformance testingprovide
adequate control if polymorph ratio
changes(e.g., dissolution)?
Establish acceptance criteriafor the relevant
performance test(s).
YES
NO
Monitor polymorph form duringstability of drug
product.
Does achange occurwhich could affect safety or
efficacy?
NO
No need to set acceptance criteriafor polymorph
change in drug product.
YES
Establish acceptance criteriawhich are
consistent with safety and/or efficacy.
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ESTABLISHING IDENTITY, ASSAY AND ENANTIOMERIC
IMPURITY PROCEDURES FOR CHIRAL NEW DRUG
SUBSTANCES AND NEW DRUG PRODUCTS CONTAINING
CHIRAL DRUG SUBSTANCES
Consider the need forverifying chiral identity
indrug substance releaseand/or acceptance
testing.
Chiral identity, assay and impurity procedures
are not needed.
YES
Is the newdrug substancechiral1?
NO
AND RACEMIC
YESAND ONE ENANTIOMER
Needed for drug substance specification2
-chiral identity3 -chiral assay4
-enantiomeric impurity5Needed for drug product
specification6 -chiral assay4
-enantiomeric impurity5
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.
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MICROBIOLOGICAL QUALITY ATTRIBUTES OF DRUGS
SUBSTANCE AND EXCIPIENTS
NO
Is the drug substances/excipient Capable of
supporting microbial Growth or viability
Provide supporting data. Microbial Limits
acceptance criteria and testing May not be
necessary
YES
YES
Is the drug substances/excipient Sterile?
No further microbial limits testing or Acceptance
criteria are necessary
NO
Establish microbial limit acceptance criteria As
per the harmonized pharmacopeial monograph
Does drug substances/excipient Synthesis/processi
ng involve Steps which inherently Reduce
microorganisms?
YES
NO
Establish microbial limit acceptance Criteria As
per the harmonized pharmacopoeial monograph
Does scientific evidence demonstrate
that Reducation steps result in microorganism
levels ltacceptance 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 Criteria and testing May not be
necessary
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.
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SETTING ACCEPTANCE CRITERIA FOR DRUG PRODUCT
DISSOLUTION
1.
What type of drug release acceptance criteria are
appropriate?
Is the dosageform designed to producemodified
release?
Establish drug release acceptance
criteria.Extended release multiple time
pointsDelayed release two stages, parallel or
sequential
YES
NO
Is drug solubilityat 37 0.5C high
throughoutthe physiological pH range?(Dose/
solubility lt 250 mL(pH 1.2 - 6.8))
NO
YES
Is dosage formdissolution rapid?(Dissolution gt
80 in 15 minutesat pH 1.2, 4.0, and 6.8)
Generally single-point dissolutionacceptance
criteria with a lower limit are acceptable.
NO
YES
NO
Has a relationship beendetermined between
disintegrationand dissolution?
Generally disintegration acceptance criteria
with an upper time limit are acceptable.
YES
Continued on next page.
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SETTING ACCEPTANCE CRITERIA FOR DRUG PRODUCT
DISSOLUTION
What specific test conditions and acceptance
criteria are appropriate? immediate release
2.
Doesdissolution significantlyaffect
bioavailability?(e.g., have relevant
developmentalbatches exhibited
unacceptablebioavailability?)
Attempt to develop test conditions and
acceptance criteria which can distinguish
batches with unacceptable bioavailability.
YES
NO
Do changes informulation ormanufacturing
variables affect dissolution?(Use appropriate
ranges.Evaluate dissolutionwithin pH 1.2 - 6.8)
YES
Are these changes controlledby another procedure
and acceptancecriterion?
YES
NO
NO
Adopt appropriate test conditionsand acceptance
criteria without regard to discriminating power,
to pass clinically acceptable batches.
Adopt test conditions and acceptance
criteriawhich can distinguish these changes.
Generally, single point acceptance criteria are
acceptable.
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SETTING ACCEPTANCE CRITERIA FOR DRUG PRODUCT
DISSOLUTION
3.
What are appropriate acceptance ranges? extended
release
Are bioavailabilitydata available for
batcheswith different drug release rates?
NO
Is drug release independent ofin vitro test
conditions?
YES
YES
NO
Can an in vitro / in vivorelationship be
established?(Modify in vitro test conditionsif
appropriate.)
Use all available stability, clinical,
andbioavailability data to establish
appropriate acceptance ranges.
NO
YES
Use the in vitro / in vivocorrelation, along
withappropriate batch data, to establish
acceptance ranges.
Are acceptanceranges gt20 of thelabeled content?
Provide appropriatebioavailability datato
validate theacceptance ranges.
YES
NO
Finalize acceptance ranges.
20
MICROBIOLOGICAL ATTRIBUTES OF NON-STERILE DRUGS
PRODUCTS
YES
No
Does the drug product contain 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 Preservative
concentration, or demonstrate the
inherent Antimicrobial activity of the drug
product.
Is the drug product a dry dosage form (e.g. solid
oral or dry powder)?
No
Establish microbial limit acceptance criteria As
per the harmonized pharmacopoeia Monograph.
YES
No
Does scientific evidence demonstrate Growth
inhibitory properties of the Drug product?
Perform microbial limits testing on a Lot-by-lot
basis.
No
YES
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.
21
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

22
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

23
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

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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

25
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

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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

27
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

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• Quality Assurance (QA) Management Procedure

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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.

30
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.

31
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,
  SOPs, forms, manuals, training files, QA
  agreements, project files etc and their effective
  archiving system.

32
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.

33
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.

34
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.

35
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.

36
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.

37
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.

38
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.

39
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.

40
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.

41
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.

42
Authorized Person

• This simple procedure describes the
  accreditation, accountabilities and
  responsibilities of an Authorized person,
  responsible for release of finished goods for
  sale.

43
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.

44
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.

45
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.

46
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.

47
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.

48
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.

49
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.

50
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.

51
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.

52
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.

53

• Quality Control Laboratory Procedures

54
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.

55
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

56
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.

57
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.

58
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.

59
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.

60
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.

61
Laboratory Waste Management

• This simple procedure describes how to dispose
  off laboratory generated wastes of toxic,
  explosive, flammable, corrosive, oxidizing and
  biologically damaging natures.

62
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.

63
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.

64
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.

65
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.

66
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.

67
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.

68
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.

69
REFERENCES

• www.ich.org
• www.fda.gov

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• THANK YOU

E-mail bknanjwade_at_yahoo.co.in Cell No
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