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Validation Department
- - -
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o Manufacturing
o Packaging and Labeling
o Product Development Laboratory
o QC - Analytical Labs
o QC - Batch Release
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o Validation Department

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Validating a Heat-Sterilizing Tunnel

The validation department writes and executes validation protocols to demonstrate that equipment, activities, and processes consistently produce products or results that meet approved specifications. Validation is conducted on manufacturing processes, aseptic operations, equipment cleaning procedures, equipment, and computerized systems. The validation group also evaluates proposed changes to determine if additional studies need to be done. Validation is also conducted on analytical methods used in laboratories; sometimes a lab methods validation group is responsible for doing these.

Example of a GMP expectation that applies to Validation

Documented evidence is available which shows that all parts of the manufacturing and control process will produce a drug product which consistently complies with its specifications.

Example of GMP requirements specific to this GMP expectation

U.S. flag  U.S.

  • There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. [211.100(a)]

  • Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. [211.110(a)]

Canadian flag  Canada

  • Every fabricator and packager/labeller and subject to subsections (3) and (4), every distributor referred to in section C.01A.003(b) and importer of a drug shall maintain a system designed to ensure that any lot or batch of the drug fabricated and packaged/labelled on premises other than their own is fabricated and packaged/labelled in accordance with the requirements of this Division. [C.02.012 #2]

European Union flag  European Union

  • Validation studies should reinforce Good Manufacturing Practice and be conducted in accordance with defined procedures. Results and conclusions should be recorded. [EU #5.21]

  • When a new manufacturing formula or method of preparation is adopted, steps should be taken to demonstrate its suitability for routine processing. The defined process, using the materials and equipment specified, shown to yield a product consistently of the required quality. [EU #5.22]
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