- Количество слайдов: 41
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 • • 1. 2. 3. Adequate education, training & experience Head of laboratory shall be responsible for Maintenance of SOPs, Protocol & documentation Organising 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-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 inprocess 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, Inprocess, 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
Specifications 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- 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