�GMP Requirements for APIs��API Webinar 28 June 2024
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Standards for API Manufacture
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PIC/S Participating Authority Requirements
SAHPRA is a PIC/S Participating Authority
SAHPRA has adopted the PIC/S GMP guides
In particular for GMP for APIs, SAHPRA requires APIs to be manufactured according to
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART II
PE 009-17 (Part II)
PIC/S GMP Part II is equivalent to ICH Q7 - GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS
The ICH Q7 Guideline is originally based on a PIC/S draft guideline on API and was adopted by PIC/S in 2001, then integrated as part II of the PIC/S GMP Guide in 2007.
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Alignment to ICH Q7
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Reliance certification for API sites
SAHPRA employs reliance for inspections, as per the requirements in the GMP Guide.
Inspectorate was accepting NRA certificates for inspection according to ICH Q7.
Inspectorate will be aligning with the current requirements of PEM i.e.
Valid GMP certificate as evidence that the site complies with GMP.
Evidence of inspection by regulatory authorities from
ICH or
ICH associated countries or
regulatory authorities that participate in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/s) or