QC QA , GMP,

1. PREPARED BY:
DEVIPRIYA P V
M PHARM
DEPT OF PHARMACEUTICAL ANALYSIS

2. GLP
• GLPs can be defined as “a body of rules, operating procedures
and practices established by a given organization that are
concerned to be mandatory with a view to ensure quality and
correctness in the results produced by a factory”.
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3. • GLP is a regulation.
• Established by worldwide bodies such as Organization
for Economic Cooperation and Development(OECD) and
ISO.
• The objective is not only quality of data but also
traceability and integrity of data.
• Contain two common elements:
1. SOPs
2. Quality Assurance Unit(QAU).
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4. REQUIREMENTS OF GLP
• Responsibilities should be defined for the sponsor
management, for study management and for QAU.
• All routine works should follow SOPs.
• Facilities such as laboratories should be large enough
and have the right construction to ensure the integrity of
a study.
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5. • Test and control articles should have the right quality
and instruments should be calibrated and well
maintained.
• People should be trained or otherwise qualified for the
job.
• Raw data and other data should be acquired, processed
and archived to ensure integrity of data.
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6. SCOPE OF GLP
• “The non clinical safety testing of test items contained in
the pharmaceutical products, pesticide products,
cosmetic products, veterinary drugs as well as food
additives, feed additives, and industrial chemicals.
• Obtain data on their properties and/or their safety with
respect to human health and/ or the environment”.
(OECD, 1998)
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8. GLP vs. GCP, GMP
Basic
research
Disease
recovery
Drug
discovery
Preclinical
development
Clinical
trials I,
II, III
manufac
turing
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Study Based Process Based
Not regulated GLP GCP GMP

9. GLP is needed for: GLP is not needed for:
• Non clinical safety studies of
development of drugs.
• Agricultural pesticide
development.
• Development of toxic
chemicals.
• Food control(food additives).
• Test of substance with regard
to explosive hazards.
• Basic research.
• Studies to develop new
analytical methods.
• Chemical tests used to derive
the specifications of a
marketed food product.
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10. SOP
• Written procedures for a laboratory's program
• Provide detailed descriptions of activities performed by
the laboratory.
• Eg: sample custody chain, sample handling and
preparation, analytical method, instrument
maintenance, record keeping etc.
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11. • Preferably written in the laboratory close to the
instrument.
• It should be either written or thoroughly reviwed by the
instrument operators.
• Not be written to explain how procedures are supposed
to work, but how they work.
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12. QAU
• Responsible for implementing quality procedure and
assessing them on a continuing basis, this will include
audits of the laboratory from time to time.
• Certify that every step of the analysis is valid.
• Serves as an internal control function.
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13. RESPONSIBILITIES OF QAU
• Maintain copy of master schedule sheet of all studies
conducted.
• Maintain copies of all protocols pertaining to the studies
for which QUA is responsible.
• Inspect studies at intervals adequate to assure the
integrity of the study .
• Maintain written and signed records of each periodic
inspection.
• Submit written status reports on each study.
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14. • Determine whether deviations from protocols and SOPs
were made with proper authorization and documentation.
• Review the final study report.
• Audit the correctness of the statement, made by the study
director, on the GLP compliance of the study.
• Prepare and sign a statement that specifies the dates of
audits and dates of reports to management and to the
study director.
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15. Protocol for conduct of non clinical
testing.
• A single protocol cover only one single experiment using
the same test article in a single type of test system.
• Indicates what will be done and when will be done.
• The exceptions from SOPs applied to the study should be
described in the protocol.
• List the SOPs used in the study.
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Protocol include:
 A descriptive title and statement of the purpose of study.
 Identification of the test and control articles.
 Name of sponsor & name and address of the testing facility.
 Details of the test system.
 Procedure for identification of test system.
 Description of experiment design.
 The description/ identification of diet used in the study

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Each dosage level of the control article and the method of
frequency of administration.
The type and frequency of the tests, analyses and
measurements to be made.
The records to be maintained.
The date and approval of the protocol by the sponsor .
Statement for proposed statistical method to be used.

18. Control on animal house
• The facility should be designed and operated in order to
minimize the effects of environmental variables on animals.
• Enough space for animals &studies to be separated & allow
operators to work efficiently.
• The environment and control system should maintain the
temperature, humidity and air flow.
• The surface of walls , doors , floors should be constructed to
allow easy & complete cleaning .
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19. • The simplest form of animal house should have 4
departments:
1. Normal animals.
2. Experimental animals.
3. Clean storage for food and feeding.
4. Washing , cleaning and incinerating.
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20. Report & Documentation
• Name and address of the facility performing the study
and dates on which the study was initiated and
completed.
• Objectives & procedures in the protocol.
• Statistical methods employed for analyzing the data.
• The test and control articles.
• Stability of the test and control articles.
• Description of the method used.
• Description of the test system used.
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• Description of the dosage, dosage regimen , route of
administration and duration.
• Description of all circumstances that have affected the quality
and integrity of the data.
• The name of the study director, scientists or professionals
involved.
• Description of the transformations, calculations or operations
performed on the data.
• The signed and dated reports of individual scientists involved
in the study.
• The location where all specimens, raw data, and the final
report are to be stored.

22. GMP
• Part of QA which ensures that products are consistently
produced and controlled to the quality standards
appropriate to their intended use and as required by the
marketing authorization.
• GMP are aimed primarily at diminishing the risks inherent
in any pharmaceutical production.
• Risk are of two types:
:cross contamination
:mix-ups.
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23. Objectives of GMP
1. Conformance to the
predetermined
specifications.
2. To minimize
contamination.
3. To minimize error.
1. To produce product of
consistent quality.
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BUILDING BLOCKS OF GMP
GMP
+
Well trained staff
+
Documentation
+
Good premises/
equipment
High Quality Product
Controlling
Quality
QC is about testing
materials
Controlling
processes
QA is about testing
processes

25. • Under GMP:
 All manufacturing procedures are clearly defined,
systemically reviwed and shown to be capable of
consistently manufacturing products of the required
quality that comply with their specifications.
 Qualification and validation are performed.
 All necessary resources are provided.
 Instructions and procedures are written in clear and
unambiguous language specifically applicable to the
facilities provided.
 Operators are trained to carry out procedures correctly.
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26.  Records are made during manufacture ; any significant
deviations are fully recorded and investigated.
 The proper storage and distribution of the products
minimizes any risk to their quality.
 All production and distribution records are retained in
comprehensible and accessible form
 A system is available to recall any batch of product from
sale or supply.
 Complaints about marketed products are examined.
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27. ICH GUIDELINES
• Unique harmonization initiative for regulators and
pharmaceutical industry.
• Originally founded in 1990.
• Over 60 guidelines on technical requirements.
Q:Quality (Q1-Q10)
S :Safety(S1-S9)
E :Efficacy(E1-E15)
M :Multidisciplinary(M1-M4)
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29. Objectives of ICH
1. To harmonize the legislative and technical requirements.
2. Mutual acceptability of data among Europe Japan & US.
3. Reducing cost of duplication of research work in meeting
regulatory requirements.
4. Reducing the timelines in the global development and
availability of new medicines after marketing approvals.
5. Maintain safeguards on quality, safety, efficacy and
regulatory obligations to protect public health.
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30. Steps in the development and
implementation of ICH guidelines:
• Step 1:Building scientific consensus.
• Step 2: Agreeing on a draft text.
• Step 3: Consulting regional regulatory agencies.
• Step 4:Adopting harmonized guidelines
• Step 5: Implementing guidelines for ICH regions.
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Quality Guidelines: Relate to the quality
area & include critical milestones such as
the carrying out stability studies, definition
of appropriate thresholds for impurities
testing, as well as evolving a flexible
approach to GMP risk management based
pharmaceutical quality
Safety Guidelines: ICH guidelines have
created a full list of safety guidelines aimed
at unearthing potential risk areas of
research like genotoxicity, carcinogenicity
& reprotoxicity
Efficacy Guidelines: ICH guidelines
relating to efficacy relate to areas such as
the conduct, design safety & reporting of
clinical trials. It also covers medicines
derived from biotechnological processes &
having used pharmacogenetics or
genomics techniques aimed at producing
better targeted medicines.
Multidisciplinary Guidelines: it covers
all those topics not covered in the quality,
safety &efficacy guidelines.ICH medical
terminology(MedDRA), CTD & the
development of ESTRI are the core aspects
of ICH guidelines in this area.
ICH
guidelines

32. Q-series guidelines
DOCUMENT TITLE
Q1A(R2) Stability testing of new substances & products
Q1B Photo stability testing of new drug substances & products
Q1C Stability testing for new dosage form
Q1D Bracketing & matrixing designs for stability testing of new drug
substances & products
Q1E Evaluation for stability data.
Q2(R1) Validation of analytical procedures.
Q3A(R2) Impurities in new drug substances.
Q3B(R2) Impurities in new drug products
Q3C(R4) Impurities: guideline for residual solvent
Q4B Evaluation & recommendation of pharmacopoeial texts for use in
the ICH region
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33. Q5A(R1) Viral safety evaluation of biotechnology products derived from cell lines
of human or animal origin
Q5B Quality of biotechnological products.
Q5C Stability testing of biotechnological/ biological products.
Q5D Derivation & characterization of cell substrates used for production of
biotechnological/ biological products
Q5E Comparability of biotechnological/ biological products subject to
change s in their manufacturing process
Q6A Specifications : test procedures & acceptance criteria for new drug
substances & new drug products: chemical substances
Q6B Specifications : test procedures and acceptance criteria for
biotechnological/biological products
Q7 GMP guide for APIs
Q8(R1) Pharmaceutical development
Q9 Quality risk management
Q10 Pharmaceutical quality system
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34. REFERENCES
1. Analytical Chemistry- 6th edition Garry D Christian. Pg
no: 124-126.
2. Quantitative analysis of drugs in pharmaceutical
formulations 3rd edition P D Sethi . Pg no:23-35.
3. Quality Assurance of Pharmaceuticals- a compedium
of guidelines and relative materials Vol II, 2nd edition.
4. Handbook Good Laboratory Practice – WHO.
5. Textbook of pharmaceutical analysis – Dr S Ravi
Sankar pg no:35.2-35.11
6. http;//www.ich.org.
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