South Africa SAPHRA: Guide to Good Manufacturing Practice for Medicines

Good Manufacturing Practice (GMP) forms the foundation of pharmaceutical quality systems, ensuring that medicines are consistently produced and controlled in accordance with appropriate quality standards. GMP requirements are critical for safeguarding the quality, safety, and efficacy of medicines supplied to patients.

The South African Health Products Regulatory Authority (SAHPRA) released the updated Guidelines for Good Manufacturing Practice of Medicines, introducing Version 10. The update includes new requirements related to the minimum years of experience required for key personnel under different licence categories in terms of Section 22C(1)(b) of the Medicines and Related Substances Act 101 of 1965.

The guideline aligns South Africa’s GMP framework with internationally recognized standards, particularly those of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), while also incorporating South African-specific regulatory expectations.

Good Manufacturing Practice (GMP) is described as a set of principles and procedures that ensure medicines and related substances are consistently manufactured to meet established standards for:

• Quality

• Safety

• Efficacy

GMP is designed to minimize risks in pharmaceutical manufacturing that cannot be eliminated through final product testing alone.

SAHPRA is an affiliated member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international organization focused on harmonizing GMP standards and inspection practices among participating authorities.

As part of this alignment:

• SAHPRA has adopted the PIC/S Guide to GMP

• Manufacturers, importers, and exporters in South Africa must comply with PIC/S GMP requirements

• SAHPRA may adopt future PIC/S GMP updates and adaptations

Regulatory Processes and GMP Approval

SAHPRA explains that GMP agreements with international regulatory authorities support:

• Information sharing

• Regulatory collaboration

• Reduced regulatory burden

• Enhanced oversight

However, these agreements do not result in automatic acceptance of foreign regulatory decisions.

Manufacturers supplying medicines in South Africa must demonstrate GMP compliance through:

• On-site inspections

• Acceptable documentary GMP evidence

GMP Approval Expectations

For GMP reliance purposes, SAHPRA requires that:

• The manufacturing site is approved by a recognized regulator

• Approval was granted within the previous three years

• The approved dosage form matches the applied dosage group

• The product type corresponds to the approved category

• The manufacturing activities match approved activities

SAHPRA also reserves the right to request additional documentation or conduct inspections regardless of compliance with these criteria.

The guideline places significant emphasis on organizational structure and personnel responsibilities. One of the most important updates in Version 10 is the inclusion of detailed minimum experience requirements for key personnel across different licence categories.

For pharmaceutical manufacturers, importers, exporters, and quality professionals, the guideline reinforces the importance of robust GMP systems, qualified personnel, and continuous compliance with evolving regulatory expectations.

Reference

For complete details, refer to the official guidance: South African Health Products Regulatory Authority (SAHPRA) – Guidelines for Good Manufacturing Practice of Medicines