PACKAGING QUALITY CONTROL, CFR 21 PART 11, GAMP 5
Packaging Quality Control in the pharmaceutical industry performs an important function for the production and quality of drug packaging materials. Before any drug is packaged, it must be tested and approved within pharmaceutical laboratories.
Therefore, a significant portion of CGMP (such as FDA 21 CFR 211) is devoted to laboratory quality control and the necessary testing of packaging.
By quality control, we mean all measures taken, including specification setting, sampling, and testing to ensure that the finished pharmaceutical packaging conforms to the specifications for identity, strength, purity, and other characteristics.
FEATURES
QC evaluates the suitability of materials, (product, packaging, etc.) at entry and during production; evaluates the performance of the manufacturing process to ensure that the correct specifications and limits are met; determines the acceptability of each batch for release.
Precisely because it is a particularly critical area for product quality and safety, QC must record every piece of information, activity, deviation.
QUALITY CONTROL of PACKAGING in the PHARMACEUTICAL SECTOR WE GUARANTEE it to you with our PROOF SYSTEMS.
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