EC guide to GMP, Ch 5 (Production)


As with facilities and equipment, production environments face their own challenges which go beyond simply having multiple products scheduled in.

The plethora of excipients and Active Pharmaceutical Ingredients (APIs), sourced from all over the globe has meant that stringent control mechanisms around sourcing are impacting daily manufacturing considerations.

Some points of interest:

  • The output from the Falsified Medicines Directive (i.e. supply chain traceability), have been accounted for.
  • Starting material control further detailed.
  • Supply chain shortages have also now been included into the chapter.  This may be of interest to those who may not see the outcome of serious production issues from a patient and market perspective.

How can you help your fellow members?

  • The Falsified Medicines Directive has a lot of emphasis on API, but equally excipient controls will lead to enhanced quality assurance mechanisms   What have you done in your company PQS to account for the changes?  Have you included all departments?
  • What is your opinion on the guidance?

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