1. GUIDED BY: PREPARED BY:
Mr PRATIK NAYAK PARTH PATEL
M.Pharm sem – I
Q.A Department
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2.  Introduction
 QA Cycle
 Inspection
 Sampling & Sampling Plans
 QCL Principles
1. Test facility organization and personnel
2. Quality Assurance (QA) program
3. Facilities
4. Apparatus, materials and reagents
5. Test systems
6. Routine Controls
7. Standard Operating Procedures (SOP’s)
8. Protocol
9. Reporting of study results 1
10. Storage and retention of records and materials

3.  Good Laboratory Practice is a quality system concerned
with the organizational process and the conditions under
which studies are
planned, performed, monitored, recorded, archived and
reported.
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4. Quality:-
 The ability to consistently produce the same product
to meet the same specifications time after time!
 Stronger, purer, higher assay, or higher yield . . . is not
better!
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5.  Quality Control :-
 The term quality control comprises of two
words :-Quality and Control.
 In terms of industrial language Control means
meeting with standards .
 Quality Control includes activities like;
sampling, testing, setting specification, organizing
Q.C. function, documentation and releasing
product for sale etc.
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6. The Quality Assurance Cycle
Patient/Client Prep
Sample Collection
Reporting •Data and Lab
Management
•Safety
•Customer
Service Sample Receipt
and
Accessioning
Record Keeping
Quality Control Sample Transport
Testing
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7.  Inspection in context with pharmaceutical
industry, include physical, chemical & biological
examination of materials to judge whether a material
is defective or non-defective by comparing the result of
test carried out with the predetermined quality
criteria.
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8. A) According to no. of items inspected
B) According to stage in the product flow
C) According to whether items are usable or not
D) According to inspection location
A) According to no. of items inspected
1.100% inspection
2.Sampling inspection
3.Check inspection
4.Zero inspection
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9. B) According to stage in the product flow
1.Incoming inspection
2.Intermediate inspection
3.Product inspection
4.pre-delivery inspection
5.Stock inspection
6.Audit inspection
7.Inspection by third party
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10. C) According to whether items are usable or not
1.Destructrive inspection
2.Non-destructrive inspection
D) According to inspection location
1.Centralized inspection
2.Roving inspection
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11.  Sampling in other words is sampling inspection.
Where the test is of destructive in
nature, sampling inspection is inevitable. Even if
the test is not destructive, sampling inspection is
likely to be better because of inspection fatigue in
100% inspection.
 It is carried out at many stages:
- incoming materials
- Material under process
- Finished product
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12.  Types of sampling plans:
A) Single sampling plan:
B) Double sampling plan:
In the sampling plan, initial sample usually, smaller in size
is drawn and a decision to accept or reject is taken on the
basis of this smaller sample.
If the result of the first sample are not decisive a second
sample is taken and the decision is taken on the basis of
combined result of two samples.
Eg. Content uniformity test in tablets.
C) Multiple sampling plan:
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13.  The sampling procedures should take account of
homogeneity and uniformity of the material.
 Homogeneous- from the same origin
 Uniform- drawn from different layers do not
show significant difference in the measurements
performed.
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14.  Characteristics of container :-
- It should not react with the sampled material nor it
should allow contamination,
- It should protect the sample from light, air, moisture.
 If sample is in a single container, it should be labeled
as….
- the product (batch no./lot no.),
- The consignment from which the sample was drawn,
- The size of the sample,
- The date & place of sampling,
- Name of the person who sampled should be recorded.
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15.  Stability testing done in order to find how long the
drug products are expected to remain within the
specification under recommended storage form.
 QCL should ascertain the hazards that are associated
with the drug product such as sub potency, physical
instability or the effect of degraded products to the
consumer
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16.  Major contributors to loss of life & property in lab. are
fires & explosions
 Study of National Fire Protection Association is
revealing :-
 67% fires are
- electric equipment (21%)
- misuse of flammable liquid (20%)
- explosion & miscellaneous (13%)
- gas (7%)
- spontaneous ignition
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17. 1. Test facility organization and personnel
2. Quality Assurance (QA) program
3. Facilities
4. Apparatus, materials and reagents
5. Test systems
6. Routine Controls
7. Standard Operating Procedures (SOP’s)
8. Protocol
9. Reporting of study results
10. Storage and retention of records and materials
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18.  Test facility
 Test site
 Sponsor
 Study director
 Principal investigator
 Quality assurance program
 Standard operating procedures
 Master schedule
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19.  Test facility management’s responsibilities
 Study director’s responsibilities
 Principal investigator’s responsibilities
 Study personnel’s responsibilities
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20.  The management should ensure that The principals of
QCL are complied with,
1. A sufficient number of qualified personnel, appropriate
facilities, equipment and materials are available
2. Records of qualifications, job descriptions, training and
experience of personnel are maintained
3. Personnel understand the functions they are to perform
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21.  Appropriate and Valid SOP’s are established and
followed
 A Study Director and a Principal Investigator, if
needed, is designated
 Documented approval of the study plan
 The study plan is available to quality assurance
personnel
 Purchased materials meet specified requirements
 Test and reference items are appropriately
characterized
 Computerized systems are suitable for their
intended purpose
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22.  Has the responsibility for the overall performance of
the study and the final report
 Approves the study plan and amendments and
communicate them to the QA personnel
 Ensures that SOP’s, study plans and their
amendments are available to study personnel
 Ensures that the SOP’s are followed, assess the
impact of any deviations and takes appropriate
corrective and preventive action
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23.  Ensures that
 Raw data are documented and recorded
 Computerized systems are validated
 SOPs are followed
 Deviations are acknowledged
 Records and data are archived
 Sign and date the final report to indicate acceptance
of responsibility
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24.  Access to the updated study plans and SOP’s
 Documented verification of the compliance of
study plan to the GLP principals
 Inspections to determine compliance of the
study with GLP principles. Three types of
inspection
 Study-based inspections
 Facility-based inspections
 Process-based inspections
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25.  Inspection of the final reports for accurate and
full description
 Report the inspection results to the management
 Statement
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26.  Suitable size, construction and location
 Adequate degree of separation of the different
activities
 Isolation of test systems and individual projects to
protect from biological hazards
 Suitable rooms for the diagnosis, treatment and
control of diseases
 Storage rooms for supplies and equipment
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27.  Separate areas for receipts and storage of the test and
reference items
 Separation of test items from test systems
 Archive facilities for easy retrieval of study plans, raw
data, final reports, samples of test items and
specimen
 Handling and disposal of waste in such a way not to
jeopardize the integrity of the study
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28.  Apparatus of appropriate design and adequate
capacity
 Documented Inspection, cleaning, maintenance
and calibration of apparatus. Calibration to be
traceable to national or international standards
 Apparatus and materials not to interfere with the
test systems
 Chemicals, reagent and solutions should be
labeled to indicate identity, expiry and specific
storage instructions.
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29.  Physical and chemical test systems:-
 Appropriate design and adequate capacity of apparatus
used for the generation of data
 Integrity of physical/chemical test systems
 Biological test systems:-
 Proper conditions for storage, housing, handling and
care
 Isolation of newly received animal and plant test
systems until health status is evaluated
 Humanely destruction of inappropriate test systems
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30.  Quality of any pharmaceutical product in particular in
greatly influenced by routine control at quality control
laboratory.
 Improper routine controls may affect the final drug
product.
 Normally practiced routine control includes :-
1. The lab and instrument should be cleaned daily.
2. The day works should be labelled neatly.
3. All the instruments are to be validated and checked
and the results rate to be recorded.
4. The samples with arrived at lab should be noted in
incoming register and they should be taken to test.
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31. 5. The humidity and temperature of the lab should be
recorded daily.
6. Log book should be filled correctly and properly for
the instruments used in the test.
7. The results of the tests are recorded and filled
according to report number.
8. The control samples are registered and maintained
properly these registers are maintained till their
expiry date.
9. Any fault in instruments or equipments should be
immediately notified to the quality control manager
10. Any complaints arise from the samples should be
properly take care off there samples should be tested
with reference to the controls.
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32.  Verification is a quality control process that is used to
evaluate whether a product, service, or system
complies with regulations, specifications, or
conditions imposed at the start of a development
phase.
 Verification can be in development, scale-up, or
production. This is often an internal process.
 Validation is a quality assurance process of
establishing evidence that provides a high degree of
assurance that a product, service, or system
accomplishes its intended requirements. This is often
an external process.
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33. Calibration
 The set of operations that establish, under specified
conditions, the relationship between values indicated
by an instrument or system for measuring (especially
weighing), recording and controlling, or the values
represented by a material measure, and the
corresponding known values of a reference standard.
Equipment qualification
 The action of proving that any equipment works
correctly and actually leads to accurate and reliable
results.
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34. An authorized written procedure giving
instructions for performing operations both
general and specific.
 Approved SOP’s to ensure the quality and integrity
of the laboratory data
 Immediately available current SOP’s relevant to the
activities being performed
 Deviations from SOP’s to be acknowledged by the
study director
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35.  SOP’s for,
 Test and reference items:-
 Receipt, identification, labeling, handling, sampling, storage
 Apparatus:-
 Use, maintenance, cleaning, calibration
 Computerized systems:-
 Validation, operation, maintenance security, change
control, back-up
 Materials, reagents and solutions:-
 Preparation and labeling
Record keeping, reporting, storage and retrieval:-
 Coding system, data collection, preparation of reports, indexing
system, handling of data
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36.  Each study shall have an approved written protocol that
clearly indicates the objective and all methods for the
conduct of study. Protocol should contain the following
items:-
1. Title and statement of the purpose of the study
2. Identification of the test and control articles by
names, chemical number or code number
3. The name of the sponsor and the name and address of
the testing facility at which the study is being
conducted
4. The number, body weight range, sex, source of
supply, strain, sub strain and age of the test system
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37.  The procedure for identification of the system
 A description of the experimental design including the
method for the control
 A description or identification of the diet used in the study
 Each dosage level expressed in milligrams per kilograms of
body weight or other appropriate unit and frequency of
administration
 Type and frequency of test, analysis and measurements to be
made
 Records to be maintained
 The date of approval of the protocol by the sponsor and the
dated signature of the study director
 Statistical method to be used
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38.  General
1. Final report for each study
2. Scientists to sign and date their reports
3. Approval by the Study Director
4. Corrections, additions, amendments to be
signed and dated by the study director
 Content of the final report
 Identification of the study
 Descriptive title, identification of the test and reference
item, purity, stability.
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39.  Information on sponsor and test facility
 Name and addresses of the sponsor, test
facility, study director, the scientists involved to the
study etc)
 Experimental starting and completion
dates
 A Quality Assurance Program Statement
 Description of materials and test methods
 Results
 Including uncertainties, level of significance
 Evaluation discussion and conclusions
 Storage (of samples, reference items, raw
data, final reports etc. 38

40.  What to retain in archives,
 The study plan, raw data, samples
 Inspection data and master schedules
 Qualification, training experience, job description
 Maintenance and calibration data
 Validation data
 SOPs
 Environmental, health & safety monitoring records
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41.  Retention period to be defined
 If any study material is disposed of before expiry the
reason to be justified and documented
 Index of materials retained in the archives
 Controlled access to the archives
 In case that the laboratory goes out of business the
archives are transferred to the relevant sponsors(s)
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42.  D.H. Shah, QA Manual, First edition, pp 125-148.
 P.P. Sharma, How to Practice GLP, First edition, pp
15-40.
 WHO Technical Report Series, No. 957, 2010
gpcl_trs957_annex1.pdf
 http://www.epa.gov/microbes/qa_qc_pcr10_04.pdf
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