• <Operator following a master manufacturing record MMR adding brown colour to other ingredients in a white bucket with air stirrer creating a swirl effect. Credit> AdobeStock_269910716
    AdobeStock_269910716
  • <Jar of various coloured capsules labelled Identity, one of the production record requirements, sitting on a white desk with blurred background of a pharmacy and female pharmacist. Credit> Freepik
    Freepik
  • <Amber bottle of tablets or capsules labelled Strength, one of the requirements of production records, with bakground of female operator weighing a powder in a plastic container. Credit> Freepik
    Freepik
  • <White plastic bottle labelled Purity, one of the requirements to establish, sitting on a lab white surface with blue capsules in front of it and blurred reagent bottles behind. Credit> Freepik
    Freepik
  • <Amber bottle of capsules labelled Quality, on the side of a conveyor carrying round yellow tablets to be packed by a team of operators. Credit> Freepik
    Freepik
  • <Square glass flask, containing red, orange and green gummies, labelled Overage, one of the requirements to record on a production record. Credit> Freepik
    Freepik
  • <Clear glass bottle full of frosted red, orange, blue and green gummies, labelled with Lot Number, one of the requirements of a production record, lying on a white surface in the middle of more gummies. Credit> Freepik
    Freepik
  • <Square glass jar with cork lid, full of red, green, yellow and orange frosted gummies, lying on a bed of tropical leaves and labelled with Yield, a requirement of a batch production record, and 98% as the result. Credit> Freepik
    Freepik
1 9
<Operator following a master manufacturing record MMR adding brown colour to other ingredients in a white bucket with air stirrer creating a swirl effect. Credit> AdobeStock_269910716
<Jar of various coloured capsules labelled Identity, one of the production record requirements, sitting on a white desk with blurred background of a pharmacy and female pharmacist. Credit> Freepik
<Amber bottle of tablets or capsules labelled Strength, one of the requirements of production records, with bakground of female operator weighing a powder in a plastic container. Credit> Freepik
<White plastic bottle labelled Purity, one of the requirements to establish, sitting on a lab white surface with blue capsules in front of it and blurred reagent bottles behind. Credit> Freepik
<Amber bottle of capsules labelled Quality, on the side of a conveyor carrying round yellow tablets to be packed by a team of operators. Credit> Freepik
<Square glass flask, containing red, orange and green gummies, labelled Overage, one of the requirements to record on a production record. Credit> Freepik
<Clear glass bottle full of frosted red, orange, blue and green gummies, labelled with Lot Number, one of the requirements of a production record, lying on a white surface in the middle of more gummies. Credit> Freepik
<Square glass jar with cork lid, full of red, green, yellow and orange frosted gummies, lying on a bed of tropical leaves and labelled with Yield, a requirement of a batch production record, and 98% as the result. Credit> Freepik

GMP-SOP-Download Drug

9.1 - Records and Reports - Production Records

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To assure uniformity from batch to batch, master production and control records for each drug product and batch size, shall be prepared, dated, and signed; often referred to as the MMR. A completed batch production and control record shall be prepared for each batch of drug product produced from an accurate reproduction of the MMR

&lt;Operator following a master manufacturing record MMR adding brown colour to other ingredients in a white bucket with air stirrer creating a swirl effect. Credit&gt; AdobeStock_269910716
&lt;Jar of various coloured capsules labelled Identity, one of the production record requirements, sitting on a white desk with blurred background of a pharmacy and female pharmacist. Credit&gt; Freepik
&lt;Amber bottle of tablets or capsules labelled Strength, one of the requirements of production records, with bakground of female operator weighing a powder in a plastic container. Credit&gt; Freepik
&lt;White plastic bottle labelled Purity, one of the requirements to establish, sitting on a lab white surface with blue capsules in front of it and blurred reagent bottles behind. Credit&gt; Freepik
&lt;Amber bottle of capsules labelled Quality, on the side of a conveyor carrying round yellow tablets to be packed by a team of operators. Credit&gt; Freepik
&lt;Square glass flask, containing red, orange and green gummies, labelled Overage, one of the requirements to record on a production record. Credit&gt; Freepik
&lt;Clear glass bottle full of frosted red, orange, blue and green gummies, labelled with Lot Number, one of the requirements of a production record, lying on a white surface in the middle of more gummies. Credit&gt; Freepik
&lt;Square glass jar with cork lid, full of red, green, yellow and orange frosted gummies, lying on a bed of tropical leaves and labelled with Yield, a requirement of a batch production record, and 98% as the result. Credit&gt; Freepik