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QC - Analytical Labs
- - -
o Buildings and Facilities Office
o Manufacturing
o Packaging and Labeling
o Product Development Laboratory
o QC - Analytical Labs
o QC - Batch Release
o Quality Assurance
o Receiving and Shipping
o Regulatory Affairs
o Training Department
o Validation Department

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Laboratory Instrumentation

The QC labs test raw materials before they are used as well as in-process materials at key points in the production process. The labs are part of the company's "quality control unit". Once the product is complete, the labs test the product to determine if it was made according to GMP and meets all of its specifications. If they find an abnormal result in their testing, they will conduct an investigation. Sometimes, their findings will point to problems that are caused by manufacturing or development failures. Analytical labs also monitor the stability of the product, making sure that it meets all specifications during its shelf life.

Example of a GMP expectation that applies to QC - Analytical Labs

The quality unit (QC analytical laboratory) tests each product before release and ensures that released products meet all applicable specifications.

Example of GMP requirements specific to this GMP expectation

U.S. flag  U.S.

  • For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. [211.165(a)]

  • There shall be appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms. [211.165(b)]

  • Acceptance criteria for the sampling and testing conducted by the quality control unit shall be adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release. The statistical quality control criteria shall include appropriate acceptance levels and/or appropriate rejection levels. [211.165(d)]

Canadian flag  Canada

  • Each lot or batch of a drug shall, prior to its availability for sale, be tested against the specifications for that drug. [C.02.018(1)]

  • No lot or batch of a drug shall be available for sale unless it complies with the specifications for that drug. [C.02.018(2)]

European Union flag  European Union

  • Laboratory documentation with the following details should be readily available to the Quality Control Department:

    • Specifications

    • Sampling procedures

    • Testing procedures and records (including analytical worksheets and/or laboratory notebooks)

    • Analytical reports and/or certificates [EU # 6.7]
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