• <Approximately 15 white oval 200mg tablets, with half-way break line, spread on a white surface ready for laboratory testing. Credit> 1173911 by leagun @ freeimages
    1173911 by leagun @ freeimages
  • <White plastic bottle labelled with Purity, one of the lab specification requirements, sitting on a white lab surface with blue capsules in front of it and blurred reagent bottles behind it. Credit> Freepik
    Freepik
  • <Microbiologist holding a round agar plate up to the light to check for colonies, an essential part of purity testing. Credit> Freepik
    Freepik
  • <Multi-coloured capsules in a plastic bottle labelled Identity, a laboratory specification requirement, sitting on a white top with some capsules laid out in front and in the background a blurred female pharmacist in a pharmacy. Credit> Freepik
    Freepik
  • <Clear, amber glass bottle containing white oval capsules and labelled Strength, one of the parameters to establish on a laboratory specification, with some capsules spread on the dark grey work surface and in the background a blurred operator weighing powder in a plastic bucket. Credit> Freepik
    Freepik
  • <Brown amber glass bottle containing capsules labelled Quality, to be determined in lab tests, on the side of a conveyor carrying round, shiny yellow tablets to a team of operators in the background for packing. Credit> Freepik
    Freepik
1 7
<Approximately 15 white oval 200mg tablets, with half-way break line, spread on a white surface ready for laboratory testing. Credit> 1173911 by leagun @ freeimages
<White plastic bottle labelled with Purity, one of the lab specification requirements, sitting on a white lab surface with blue capsules in front of it and blurred reagent bottles behind it. Credit> Freepik
<Microbiologist holding a round agar plate up to the light to check for colonies, an essential part of purity testing. Credit> Freepik
<Multi-coloured capsules in a plastic bottle labelled Identity, a laboratory specification requirement, sitting on a white top with some capsules laid out in front and in the background a blurred female pharmacist in a pharmacy. Credit> Freepik
<Clear, amber glass bottle containing white oval capsules and labelled Strength, one of the parameters to establish on a laboratory specification, with some capsules spread on the dark grey work surface and in the background a blurred operator weighing powder in a plastic bucket. Credit> Freepik
<Brown amber glass bottle containing capsules labelled Quality, to be determined in lab tests, on the side of a conveyor carrying round, shiny yellow tablets to a team of operators in the background for packing. Credit> Freepik

GMP-SOP-Download Drug

9.2 - Records and Reports - Laboratory Records

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Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays to demonstrate batches of drug product meet established specifications of identity, strength, quality, and purity, including all raw data

&lt;Approximately 15 white oval 200mg tablets, with half-way break line, spread on a white surface ready for laboratory testing. Credit&gt; 1173911 by leagun @ freeimages
&lt;White plastic bottle labelled with Purity, one of the lab specification requirements, sitting on a white lab surface with blue capsules in front of it and blurred reagent bottles behind it. Credit&gt; Freepik
&lt;Microbiologist holding a round agar plate up to the light to check for colonies, an essential part of purity testing. Credit&gt; Freepik
&lt;Multi-coloured capsules in a plastic bottle labelled Identity, a laboratory specification requirement, sitting on a white top with some capsules laid out in front and in the background a blurred female pharmacist in a pharmacy. Credit&gt; Freepik
&lt;Clear, amber glass bottle containing white oval capsules and labelled Strength, one of the parameters to establish on a laboratory specification, with some capsules spread on the dark grey work surface and in the background a blurred operator weighing powder in a plastic bucket. Credit&gt; Freepik
&lt;Brown amber glass bottle containing capsules labelled Quality, to be determined in lab tests, on the side of a conveyor carrying round, shiny yellow tablets to a team of operators in the background for packing. Credit&gt; Freepik