Good Laboratory Practices•The exact definition depends on who is defining it and for

what purpose. •A broad definition encompasses such issues as

•organization of the laboratory,• management,

•personnel, •facilities,

•equipments, •operation,

• method validation, •quality assurance and

•record keeping .

Good Laboratory Practices

• The goal is to certify that every step of the analysis is valid.

• The aspects that need to be particularly addressed will vary by laboratory.

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.

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,

• environmental samples etc.

Good Laboratory Practices

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

• Schedule L-1 requirements for GLP

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 or adapted 7 maintained to suit the performance of all quality control tests & analysis required before, during & after manufacture.

• Away from external & internal traffic.

Premises

• Design & construction should prevent entry of rodents & insects

• Interior surfaces of walls, floors& ceilings should be smooth& free from cracks

• Temp. & relative humidity should be appropriate for desired functions

• Bio burden will be routinely maintained.

Premises

• Separate facility for

• Instrumentation

• Chemical analysis/wet chemistry

• Micro lab/sterility/ pyrogen testing lab

• Hot room: fuming hood

• Stability room

• Reference sample/control samples room

Premises

• 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

1. Maintenance of SOPs, Protocol & documentation

2. Organising audits & follow up of Corrective action

3. 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-standardisation & signature of the chemist who has prepared it.

• Reference standards & working standards should be dated & stored at proper conditions. They should be handled & used carefully in consultation with senior chemist.

• 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• Written operating instructions should be

readily available or preferably be displayed for each instrument.

• Records shall have Name of eqip., Mfg.’s name & instruction manual, model no.,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

• 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

• 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.

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.

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, FP.

Standard Operating Procedures

• To store data in paper format, humidity conditions shall be maintained.

• Data in the form of disc & tape should be stored with care.

• For storage on optical disc, its life shall be longer than storage time.

• Keep a photocopy of data on thermal paper.

• The aim of documentation is

• To define specifications for all materials, method of manufacture & control

• To inform all concerned mfg, personnel how when & why a batch is rejected.

• To provide audit trail for to permit investigation of any suspected defective batch.

Documents

• 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 & authorised 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.

• Authorised persons will have access to data to maintain its integrity & security.

Records

• Records should have following details.– Analytical report no.– Name of the sample– Date of receipt of sample– Batch/lot no.– 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 & in case of drugs, requirements complying schedule U

– Records should also contain the basic data & calculations from which test results were derived.(e.g. weighings, readings, recorder charts, instrument printouts etc.)

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.

Good house keeping & 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.

Good house keeping & Safety

• Government of India specifies SOPs as

• Circulation of safety data sheet

• Eating, drinking, smoking and keeping food items in the lab is prohibited.

• Adequate facilities for storage & disposal of animal waste

• Protective clothing to be provided.

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 & CA 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 analysed & 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.

Standard Operating Procedures

• Sops required for• Analysis of drugs• 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.• 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

SpecificationsRM & 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.

SpecificationsIn-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.

SpecificationsIn-Process & FP- contd.

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

• The storage conditions & precautions

• The shelf life.

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