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  3. Dietary Supplement - 21 CFR 111 - GMP SOPs
  5. 10.3 - Laboratory Specifications
  • <Row of three digital analytical balances, with white plastic,slide glass doors and round stainless steel plate, for weighing and testing dietary supplements. Credit> 147005408 © Ryzhov Sergey | Dreamstime.com
    147005408 © Ryzhov Sergey | Dreamstime.com
  • <Female microbiologist wearing white labcoat and safety specs holding up a round agar plate to look for microbial growth, a dietary specification test requirement. Credit> Freepik
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  • <Capsules in a brown glass jar labelled identity, a dietary specification test requirement, surrounded by green leaf plants on a smooth stone table. Credit> Freepik
    Freepik
  • <Red and yellow capsules in a clear glass jar labelled strength, a dietary specification test requirement. Credit> Freepik
    Freepik
  • <Capsules in a clear glass jar on a wooden table with panel wood wall behind with word composition written in front, a dietary specification test requirement. Credit> Freepik
    Freepik
  • <Neon capsules in a clear glass jar in front of a neon sign and wall labelled with purity, a dietary specification test requirement. Credit> Freepik
    Freepik
  • <Male QC Analyst wearing lab coat, blue gloves, and safety specs, stood in front of an HPLC used for assays on dietary supplements, preparing a sample to test in a flask. Credit AdobeStock_403421068
  • <Female QC Analyst stood in front of a grey laboratory worktop reading a specification for a dietary supplement she is preparing to test. Credit> Freepik
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By GMP-SOP-Download Dietary Supplements

10.3 - Laboratory Specifications

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For each dietary supplement that you manufacture you must establish product specifications for the identity, purity, strength, and composition of the finished batch, and for limits on those types of contamination that may adulterate the finished batch, to ensure the quality. Failure to meet any specification must be investigated by Quality Control

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GMP-SOP-Download Dietary Supplements10.2 - Laboratory Sampling
<Female QC Analyst in the warehouse holding a clipboard sampling a white powder into a clear jar from a white sack on a wooden pallet. Credit> Freepik
<Hands of a laboratory analyst wearing blue gloves holding a pen and completing a phase 1 OOS investigation on a clipboard in blurred lab. Credit> AdobeStock_391585993
GMP-SOP-Download Dietary Supplements10.4 - Laboratory OOS Investigation & Form
<Row of three digital analytical balances, with white plastic,slide glass doors and round stainless steel plate, for weighing and testing dietary supplements. Credit> 147005408 © Ryzhov Sergey | Dreamstime.com
$28.00 USD
$28.00 USD