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  3. Sub-Parts F to G: Production and Process Controls
  5. 6.0 - Production Overview
  • <Row of glass vaccine vials with metal caps passing down a conveyor belt with guardrails keeping them in place to be filled. Credit> AdobeStock_513373066
    AdobeStock_513373066
  • <Female production operator cleaning the metal grid floor of a plant room area with a brush. Credit> AdobeStock_403490907
    AdobeStock_403490907
  • <White small mini-tabs or pillules being poured onto a stainless steel mold with rows and rows of round holes to take one pillule. Credit> AdobeStock_253324940
    AdobeStock_253324940
  • <Close up of the lid of a polished mirror finish stainless steel mixing vessel with others blurred in the background and an overhead blue motor for an agitator stirrer. Credit> AdobeStock_336493389
    AdobeStock_336493389
  • <Orange oval tablets passing down a stainless steel chute onto a rotary filling machine which is collating the tablets in larger circles into one aligned row. Credit> AdobeStock_477674087
    AdobeStock_477674087
By GMP-SOP-Download Drug

6.0 - Production Overview

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There shall be written procedures for production and process control designed to assure that the drug products have the correct identity, strength, quality, and purity. These must be followed and documented at the time of performance. Any deviation from the written procedures shall be recorded and justified

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<Square, metal floor drain in a grey stone tiled floor. Credit> AdobeStock_245003730
GMP-SOP-Download Drug6.1 - Prevention of Cross-Contamination
<Row of glass vaccine vials with metal caps passing down a conveyor belt with guardrails keeping them in place to be filled. Credit> AdobeStock_513373066
$26.00 USD
$26.00 USD