20191108064505519_11_i_lab_controls___analytical_testing_2019f.pdf - SUBPART I \u2013 LABORATORY CONTROLS CHEM 519 \u2013 GMPs 1 Equipment Standards\/Materials


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1 SUBPART I – LABORATORY CONTROLS CHEM 519 – GMPs ANALYTICAL LABS Equipment Standards/Materials Analysts/Training Data system Methods/Specs 1 2
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2 SUBSECTION 211.160 GENERAL REQUIREMENTS Establishment of or changes to required specifications, standards, sampling plans, test procedures or other lab control mechanisms are drafted by the appropriate organizational unit and approved by QA These are followed and documented at the time of performance Deviations are recorded and justified. SUBSECTION 211.160 GENERAL REQUIREMENTS Laboratory Controls will include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures. It must be assured that components, drug product containers and closures, in-process samples, labeling and drug product, conform to standards of identity, strength, purity and quality. Conformance to appropriate written specification must be determined for components, drug product containers and closures, labels, in-process materials and drug product. 3 4
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3 SUBSECTION 211.160 GENERAL REQUIREMENTS Calibration of instruments, apparatus, gauges and recording devices is done at suitable intervals According to a written program with specific: Directions Schedules Limits Remedial action Equipment and Instruments not meeting established specifications, are not used. SUBSECTION 211.165 TESTING AND RELEASE FOR DISTRIBUTION Each batch of drug product is tested for conformance to final specification These include identity and strength tests for each active ingredient prior to release Testing for microorganisms is required, if the product is required to free of them 5 6
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4 SUBSECTION 211.165 TESTING AND RELEASE FOR DISTRIBUTION There are written procedures for sampling and testing Acceptance criteria for sampling and testing are adequate to assure the drug product meets specification and statistical quality control for approval and release. The accuracy, sensitivity and reproducibility of test methods are established and documented Drug product failing to meet specification or other quality control parameters shall be rejected. SUBSECTION 211.166 STABILITY TESTING Written program to assess the stability characteristics of a drug product. Testing is done using the product in the same container system it is to be marketed in. Reliable, meaningful and specific test methods are used. Written assessment of stability and compatibility to indicate no degradation of the product for the expected period of use. ICH Organization Q1A(R2) harmonized US, EU & JP 7 8
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5 Q1A(R2) STABILITY TESTING OF NEW DS AND DP Establish requirements for necessary data to support an expiration dating for a pharmaceutical products Storage conditions and frequency of testing Size and number of batches needed for registration
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