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Compounded medicines and good manufacturing practice (GMP)

Guide to the interpretation of the PIC/S Guide to GMP for compounded medicinal products

29 May 2017

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Interpretation - personnel - chapter 2

Topic PIC/S clause Interpretation
Personnel Chapter 2

The person performing the release for supply activity should be appropriately qualified and experienced. These persons should have a comprehensive understanding of the specific dosage form, manufacturing processes and controls and relevant GMP requirements. Normally, they have a pharmacy qualification but this is not mandated. It is important that they have sufficient and relevant GMP experience.

Any persons performing the release for supply function should be named in the Quality System.

Persons performing the release function should be independent from the Production function. If the number of personnel at the manufacturer is too few to allow for this then the person performing releasing duties should not release products that they have personally manufactured, i.e. been involved in the dispensing, compounding, or labelling operations. The separation of job functions should be clearly documented within the site's QMS.

As normally expected, the person named in the licence as responsible for QC should have adequate oversight of this function.

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