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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 - premises and equipment - chapter 3

Topic PIC/S clause Interpretation
Sanitisation of items for transfer into clean areas

For sterile preparations, see below under "Manufacture of Sterile Medicines"

For non-sterile preparations, appropriate controls should be in place to ensure that all equipment and materials used in production areas are adequately sanitised to prevent contamination and cross contamination.

Environmental monitoring

For sterile preparations, see below under "Manufacture of Sterile Medicines"

For non-sterile medicines, environmental monitoring should be undertaken periodically to demonstrate that the manufacturing environment is appropriate. Monitoring methods and frequencies should be justified based on a risk assessment and data from the qualification of the production environment.

Prevention of cross-contamination 3.6

Manufacture of cytotoxics and antibiotics should be performed in separate areas where toxicological data does not support a controllable risk, e.g. allergenic potential from highly sensitising materials much as β-lactams; or (for non-sensitising molecules) there should be a validated cleaning program to demonstrate that there is no cross contamination.

Similarly, preparation of biological medicines (e.g. monoclonal antibodies) should be carried out with similar strategies to avoid cross-contamination.

In all cases where dedicated equipment is not used, a risk assessment should be available that shows the mitigation steps that should be implemented.

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