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  3. 8.3 - Laboratory Specifications
  • <Bottle of capsules labelled Identity, one of the drug specification requirements, on a white table with a blurred pharmacy and pharmacist background. Credit> Freepik
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  • <Brown amber bottle of caplets labeled Quality, one of the drug specification requirements, sitting on the side of a tablet conveyor transporting yellow caplets to three operators for packing. Credit> Freepik
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  • <Brown amber bottle of capsules labelled Strength, one of the drug specification requirements, in front of a female operator weighing powder into a plastic container. Credit> Freepik
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  • <White bottle labelled Purity, one of the drug specification requirements, with some blue capsules in front of it on a white lab surface and behind it some reagent bottles with clear liquids. Credit> Freepik
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  • <Female microbiologist holding up an agar plate to the light to check for colony growths, part of purity testing of drugs. Credit> Freepik
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  • <Female laboratory analyst stood in the lab, with a male analyst behind her, reading a specification for testing. Credit> Freepik
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By GMP-SOP-Download Drug

8.3 - Laboratory Specifications

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There must be appropriately authorised and dated specifications for all components, including active materials and excipients, packaging, in-process materials, and drug products designed to ensure that each lot number conforms to appropriate standards of identity, strength, quality and purity

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<Bottle of capsules labelled Identity, one of the drug specification requirements, on a white table with a blurred pharmacy and pharmacist background. Credit> Freepik
£19.99 GBP
£19.99 GBP