QC laboratory controls

QUALITY CONTROL LABORATORY & CONTROLS MOHAMMAD YUNOOS, M.Pharm., (Ph D) ASSISTANT PROFESSOR NIMRA COLLEGE OF PHARMACY VIJAYAWADA : 

QUALITY CONTROL LABORATORY & CONTROLS MOHAMMAD YUNOOS , M.Pharm., (Ph D) ASSISTANT PROFESSOR NIMRA COLLEGE OF PHARMACY VIJAYAWADA MOHAMMAD YUNOOS

QUALITY CONTROL LABORATORY: 

QUALITY CONTROL LABORATORY QC lab area should be separated from production areas. QC laboratories should be designed to suit the operations to be carried out in them. Sufficient space should be given to avoid mix-ups and cross contamination. There should be adequate suitable storage space for samples, reference standards, solvents, reagents and records. 2/11/2012 2 MOHAMMAD YUNOOS

QUALITY CONTROL LABORATORY: 

QUALITY CONTROL LABORATORY QC Lab design should take into account for the suitability of construction materials, prevention of fumes and ventilation. There should be separate air supply to laboratories. Separate room for instruments to protect them against electrical interference, vibration, contact with excessive moisture and other external factors. 2/11/2012 3 MOHAMMAD YUNOOS

QUALITY CONTROL LABORATORY: 

QUALITY CONTROL LABORATORY Adequate facilities, trained personnel and approved procedures must be available for sampling, inspecting and testing starting materials, packaging materials, and intermediate, bulk, and finished products. 2/11/2012 4 MOHAMMAD YUNOOS

LABORATORY CONTROLS: 

LABORATORY CONTROLS There should be documented procedures describing sampling, testing, approval or rejection of materials and recording and storage of laboratory data . Laboratory records should be maintained. All specifications, sampling plans and test procedures should be appropriate to ensure that raw materials, intermediates, APIs, and labels and packaging materials conform to established standards of quality and/or purity. 2/11/2012 5 MOHAMMAD YUNOOS

LABORATORY CONTROLS: 

LABORATORY CONTROLS All specifications, sampling plans and test procedures should be appropriate to assure that components, drug product containers, closures, in process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity which are used in the manufacture, processing, packing, or holding of drug products. 2/11/2012 6 MOHAMMAD YUNOOS

LABORATORY CONTROLS: 

LABORATORY CONTROLS Specifications should include control of impurities If API has a specification for microbiological tests, setting of limits for total microbial counts and objectionable organisms should be established and met. Laboratory controls should be followed and documented at the time of performance . Out-of-specification result obtained should be investigated and documented according to a procedure. Reagents and standard solutions should be prepared and labeled. 2/11/2012 7 MOHAMMAD YUNOOS

LABORATORY CONTROLS: 

LABORATORY CONTROLS Source of each primary reference standard should be documented. Records should be maintained of each primary reference standard’s storage and use. Appropriate testing should be performed to establish fully the identity and purity of the primary reference standard. Documentation of this testing should be maintained. Secondary reference standards should be appropriately prepared, identified, tested, approved and stored. 2/11/2012 8 MOHAMMAD YUNOOS

LABORATORY CONTROLS: 

LABORATORY CONTROLS Reference standards should be properly labelled with at least the following information: (a) name of the material (b) batch or lot number and control number (c) date of preparation (d) shelf-life (e) potency (f) storage conditions. 2/11/2012 9

LABORATORY CONTROLS: 

LABORATORY CONTROLS Reserve samples of each API batch should be retained for 1 year after the expiry date of the batch or 3 years after distribution of the batch. Expiry or retest date should be based on an evaluation of data derived from stability studies. Testing program should be established and documented to monitor the stability characteristics of APIs and the results should be used to confirm appropriate storage conditions and retest or expiry dates. 2/11/2012 10 MOHAMMAD YUNOOS

LABORATORY CONTROLS: 

LABORATORY CONTROLS Written testing program designed to assess the stability characteristics of drug products and results of such stability testing shall be used in determining appropriate storage conditions and expiration dates. The written program shall be followed and shall include: (1) Sample size and test intervals (2) Storage conditions for samples used for testing (3) Specific test methods; (4) Testing of the drug product in the same container-closure system as that in which the drug product is marketed. 2/11/2012 11 MOHAMMAD YUNOOS

LABORATORY CONTROLS: 

LABORATORY CONTROLS Calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision. Each batch of drug product shall be tested to final specifications including the identity and strength of each active ingredient prior to release. Sampling and testing plans shall be described and followed in written procedures that include the method of sampling and the number of units per batch to be tested. Qualification and validation must be performed. 2/11/2012 12 MOHAMMAD YUNOOS

LABORATORY CONTROLS: 

LABORATORY CONTROLS Acceptance criteria for the sampling and testing shall be adequate to assure that batches of drug products meet specification and standards for approval and release. Drug products failing to meet established standards or specifications shall be rejected. Animals used in testing components, in-process materials, or drug products for compliance with established specifications shall be maintained and controlled to assures their suitability for their intended use. They shall be identified and adequate records shall be maintained showing the history of their use. 2/11/2012 13 MOHAMMAD YUNOOS

PowerPoint Presentation: 

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PowerPoint Presentation: 

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