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Training on

introductionto

Good Laboratory Practice (GLP)

Prepared by Arshad Hussain

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.

Good Laboratory Practices Established by worldwide bodies such as:• Organization for Economic co-operation

and Development (OECD)• International Organization for

Standardization (ISO).

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.

Good Laboratory Practices

• Good Laboratory practices for chemical laboratory as a compliance to GMP requirements.

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.

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.

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.

Premises Cont.. Separate facility for:• Instrumentation.• Chemical analysis / wet chemistry.• Micro lab.• Hot Lab/room.• Analytical room.• Reference sample/control samples room.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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

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.

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.

Specifications (In-process & FP) cont..

• The qualitative & quantitative requirements , with the acceptance limits for release.

• The storage conditions & precautions. • The shelf life.

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.

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.

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.

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.

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.

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.)

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.

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.

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.

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.

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.

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.

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.

Summary

• Adequate facility, trained personnel, approved procedures.

• Validated test methods• Records- Reports, specifications,

calibration SOPs• Analysis of RM, In-process & FP for release• Product complaints & recall

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