2. Good Laboratory Practices
• Good Laboratory practices can be defined as “a
body of rules, operating procedures and practices
established by a given organization that are
considered to be mandatory with a view to
ensuring quality and correctness in the results
produced by a laboratory.
• The goal is to certify that every step of the
analysis is valid.
3. Good Laboratory Practices
Established by worldwide bodies such as:
• Organization for Economic co-operation and
Development (OECD)
• International Organization for Standardization
(ISO).
4. Good Laboratory Practices
Government agencies have adopted them as
rules for laboratories involved in analyzing
substances that require regulation. e.g.
• Pharmaceuticals,
• Foods,
• Chemicals,
• Environmental samples etc.
5. Good Laboratory Practices
• Good Laboratory practices for chemical
laboratory as a compliance to GMP
requirements.
6. Cleanliness
• Control laboratories & equipment should be kept clean in
accordance with written cleaning schedules.
• All laboratory personnel should wear clean protective
clothing appropriate to the duties being performed.
• The disposal of waste material should be done carefully &
responsibly in accordance with procedures which should
be documented.
• Keep the work place clean & uncluttered & do not get
distracted at work by other people.
7. Premises
• Located, designed, & constructed to suit
the performance of all quality control
tests & analysis required before, during &
after manufacture.
• This should be away from vibrating and
heating place.
8. Premises Cont..
• Design & construction should prevent entry
of rodents & insects.
• Interior surfaces of walls, floors & ceilings
should be smooth & free from cracks.
• Temperature & relative humidity should be
appropriate for desired functions.
• Bio burden will be routinely maintained.
9. Premises Cont..
Separate facility for:
• Instrumentation.
• Chemical analysis / wet chemistry.
• Micro lab.
• Hot Lab/room.
• Analytical room.
• Reference sample/control samples room.
10. Premises Cont..
• Animal house shall have approval of
Committee for the purpose of Control &
Supervision on experiments on Animals
(CPCSEA).
• SOPs for maintenance of animal house.
11. Personnel
• Adequate education, training & experience.
Head of laboratory shall be responsible for:
• Maintenance of SOPs, Protocol & documentation.
• Organizing audits & follow up of Corrective
action.
• Investigation of technical complaints.
12. Reagents
• The reagents should be dated upon receipt or
preparation & labelled for identification.
• Reagents made up in the laboratory should be
prepared by competent persons according to laid-
down procedures.
• The labels on the reagent bottles should indicate the
concentration, standardization factor, shelf life &
storage conditions , date of preparation, date of re-
standardization & signature of the chemist/ analyst
who has prepared it.
13. Reagents cont..
• Reference standards & working standards
should be dated & stored at proper
conditions. They should be handled & used
carefully in consultation with supervisor.
• MSDS of hazardous & poisonous chemicals.
• Distilled / DM water- analysis.
14. Equipments
• Laboratory instruments & equipments should be
serviced & calibrated at suitable intervals according
to written procedures by persons or a service
agency & validated,(SOP for operation &
calibration).
• Readily available records must be maintained for
each one of them.
• Next servicing or calibration due date should also
be mentioned on them.
• Separate room under control temp. & humidity.
15. Equipments cont..
• Written operating instructions should be readily
available or preferably be displayed for each
instrument.
• Records shall have Name of equipments, Mfg.’s
name & instruction manual, model number, list
of spares & accessories, etc.
• Defective instrument should be withdrawn from
use until the fault has been rectified.
16. Sampling
• Sample should be a proper representative
of bulk product.
• A trained & authorized sampler should
sample out using appropriate , clean
Sampling equipments , following safety
precautions & sampling norms.
17. Sampling cont..
Written Sampling SOP should include:
Method of sampling
Equipment to be used
The amount of sample to be taken
Instructions for any required sub division of sample
The type & condition of sample container to be used
Any special precaution to be observed
Cleaning & storage of sampling equipment.
18. Sampling cont..
• The Sample container should have labels bearing
details about Name of material, Batch no., Mfg. Date,
expiry date, Name of manufacturer, & quantity
sampled.
• Those containers from which samples are drawn, are
marked with ‘sampled’ stamp with date & signature
of the chemist so that they are identifiable from bulk
containers.
• Sampling equipments should be cleaned after each
use & stored separately from other laboratory
equipments.
19. Procedure & Documentation
• Method of analysis & specifications
• SOP for systems, instruments.
• Reports- Analytical reports of batch,
stability report, working standards,
validation reports, Monitoring quality of
water, effluents discharged, RM, In-
process, Final product.
20. Standard Operating Procedure
Sops required for:
• Analysis of drugs/chemicals.
• Sample handling & accountability.
• Receipt, identification, storage & sampling of test &
control articles.
• Cleaning, maintenance and calibration of
equipments
• Responsibilities of audit team personnel.
21. Standard Operating Procedures
• Healthy & safety precaution
• Storage & maintenance of microbial cultures.
• Maintenance of animal rooms whenever
used.
• Use & storage of reference standards
• Training programs & their frequency
• House Keeping
• Document control
22. Standard Operating Procedures
• Retention & disposal of control samples.
• SOPs should be reviewed periodically.
• SOPs should include designation of the
person responsible for intended activity.
• Complaints & Product recall procedures
23. Specification (RM & PM)
• Designated name & material code reference
• Reference to pharmacopoeia , if any.
• Qualitative & quantitative requirement with acceptance
limit
• Specimen of printed material
• Directions for sampling & testing of reference to
procedures
• Storage conditions & maximum period of storage before
retesting.
24. Specifications (In-process & FP)
• For in-process materials specifications should be
available & authenticated.
• For FP, their should be designated name of product &
code ref.
• The formula or ref. to the formula & pharmacopoeial
ref.
• Directions for sampling & testing or a ref. to
procedures
• A description of dosage form & package details.
25. Specifications (In-process & FP) cont..
• The qualitative & quantitative requirements ,
with the acceptance limits for release.
• The storage conditions & precautions.
• The shelf life.
26. Testing
• Samples should be tested in accordance with the
written methods & referred to in relevant
specifications.
• In- process checks done by QC personnel on the
batches in production should also be attached to
the analytical reports for the batch.
• Test methods should be validated.
• Where the results of testing appear doubtful, repeat
the test/s but do not fabricate the results to cover up
mistakes or to avoid work.
27. Documents
• All the departmental systems & procedures ,
specifications for all input materials, intermediates
& finished products & all tests and methods of
analysis should be documented.
• All raw data, formats of analytical reports , under
test, approved & rejected labels , various in-process
checks , calibration check records should be
documented & available.
• Archives for storage, & retrieval of records,
Retention time should be maintained.
28. Documents cont..
• Documents shall specify the title, nature &
purpose.
• They shall be laid out in an orderly fashion &
easy to check.
• Documents shall be approved, signed,
regularly reviewed, and dated by appropriate
& authorized person.
29. The aim of documentation
• Documents shall specify the title, nature &
purpose.
• They shall be laid out in an orderly fashion &
easy to check.
• Documents shall be approved, signed,
regularly reviewed, and dated by appropriate
& authorized person.
30. Records
• Raw data refers to records of original observations.
• Make detailed records of the results of the tests &
analyses of all materials, intermediates & finished
products & in process tests done, environmental
monitoring, calibrations etc.
• Changes or corrections in the entry should be
single line strike.
• Authorized persons will have access to data to
maintain its integrity & security.
31. Records cont..
• Records should have following details-
Analytical report number
Name of the sample
Date of receipt of sample
Batch/lot number
Protocols of tests applied
Signature of the analyst
Opinion & sign of approved analyst
Any other relevant & extra information e.g. date of expiry , date
of release.
Records should also contain the basic data & calculations from
which test results were derived.(e.g. weighing, readings, recorder
charts, instrument printouts etc.)
32. Good housekeeping & safety
• People working in the laboratory should look after safety
aspects of their work for themselves, their colleagues & the
organization.
• They should wear appropriate safety gadgets while working
with hazardous , corrosive chemicals & inflammable solvents.
• Persons in the department should be trained to operate fire
fighting apparatus.
• Persons in the department should be familiar to first-aid
techniques in case of emergency till medical help is available.
33. Safety
• Waste materials awaiting disposal should be safely
stored.
• Flammable & halogenated solvents & other
contaminated waste liquids should not be poured into
the drains carrying the factory effluent.
• They should be collected separately & disposed off
suitably .
• There should be separate waste containers for broken
glass.
34. Training
• Persons in the department should be
adequately qualified & provided suitable
training to carry out their responsibilities in
a competent & reliable manner.
• Records of training should be maintained.
35. Reference Materials
• Traceable to Government body Or international
agency.
• Working std. shall be prepared using ref. std. &
records of same will be maintained
• Maintain a register for ref. material including
source of supply, code no. ID no., storage
conditions, mfg. & expiry date.
• Handled & stored properly.
36. Quality System
• Documented quality policy.
• Compliance with GLP.
• Non conformities noted by internal & external
audits should be corrected & documented.
• The head of laboratory is responsible for
schedule & conduct of the audit.
37. Internal System Quality Audits
• The head of laboratory is responsible for schedule &
conduct of audit.
• Manager will be responsible to maintain all records &
protocols of the analysis which are being checked by
audit team.
• Should be carried out by competent personnel to meet
regulatory requirements.
• Any non compliance reported in the audit should be
analyzed & CA should be documented.
38. Management Review
At least once in 12 months to cover-
• Internal & external audit report
• Complaints & customer feedback received
from laboratory customers
• Training records of the staff.
• Other laboratory requirements.
