SAPAHRA Guidance: Good Manufacturing Practice (GMP) for Medicines

The South African Health Products Regulatory Authority (SAHPRA) has released the Guidelines to Good Manufacturing Practice for Medicines, effective 17 November 2025.

This updated guideline aligns South Africa with the latest PIC/S GMP standards and strengthens regulatory expectations for manufacturers, importers, exporters, and distributors operating within the South African market.

GMP is a system ensuring that medicinal products are consistently produced and controlled to required quality standards, minimising risks that cannot be eliminated through final product testing. GMP covers every aspect of manufacturing—from raw materials and equipment to personnel training, hygiene, and documentation.

PIC/S is an international organisation that harmonises GMP standards across participating inspection authorities. SAHPRA is a PIC/S participating authority, which means the South African GMP framework is aligned with PIC/S global standards.

1. Introduction

The guideline states that Good Manufacturing Practice is fundamental to ensuring medicine quality, safety, and efficacy.SAHPRA, as a PIC/S member, adopts PIC/S standards to harmonise inspection practices and ensure South African facilities meet equivalent international GMP expectations.GMP applies to all human-use medicines and is recommended for veterinary products as well.

2. Legal Provisions and PIC/S Alignment

South African law (Medicines and Related Substances Act, 1965; Act 101 of 1965) requires that all manufacturers, importers, exporters, wholesalers, and distributors be licensed.The guideline confirms that SAHPRA fully adopts the PIC/S Guide to GMP, with adjustments only where necessary for South African context—particularly the replacement of PIC/S Annex 16 with a South Africa–specific Annex 16 provided in Section 4.Any reference to “Responsible Person” in PIC/S must be understood as “Responsible Pharmacist” locally.

3. Regulatory Processes

3.1 Principles

SAHPRA participates in international regulatory reliance and information-sharing initiatives.However, approvals from recognised foreign regulators do not guarantee automatic acceptance—SAHPRA may still request inspections or additional documentation.

3.2 GMP Approval Guidance

A site may be considered for GMP reliance if:

• It was approved by a recognised regulator (Appendix 1).

• The approval occurred within the past 3 years.

• The dosage form, product type, and activities match those approved by that regulator.

Despite reliance pathways, SAHPRA retains discretion to inspect or reject any site.

4. Annex 16 – South African Specific GMP Requirements

Section 4 provides country-specific adaptations to the PIC/S guideline.

4.1 Organisation & Personnel

4.1.1 Principles

The guideline stresses that GMP compliance depends heavily on people.Companies must have an authorised organisational chart with clear reporting lines and documented job descriptions.All personnel must be trained in GMP, their specific duties, and hygiene practices.Production and Quality Assurance (QA) must be headed by individuals of equal authority and independent roles. 4.1.2 Responsibilities of Key Personnel

The guideline outlines detailed legal and functional responsibilities for:

• Managing Director

Responsible for the entire pharmacy business, ensuring compliance with the Pharmacy Act and Medicines Act, oversight of human resources, regulatory processes, recordkeeping, and appointment of responsible pharmacists.

• Head of Production

Responsible for production areas, equipment, personnel, manufacturing instructions, and ensuring batch manufacture complies with the master formula.

• Head of Quality Control (QC)

Has authority to establish, verify, and implement all QC procedures.May report to the QA Manager but must remain integral to quality decision-making.

• Shared Responsibilities (Production & QC)

Both must collaborate on quality-related responsibilities, ensuring clarity and no overlaps.

• Responsible Pharmacist

The guideline provides a highly detailed list of RF responsibilities, including:

• Continuous supervision of the pharmacy

• Ensuring staff are appropriately registered

• Implementing corrective actions from inspection findings

• Ensuring proper storage, handling, and documentation of medicines

• Ensuring batch release meets all marketing authorisation and GMP requirements

• Coordinating recalls, audits, and self-inspections

• Ensuring security and prevention of unauthorised access to medicines

This section is one of the most extensively detailed parts of the guideline.

• Pharmacist or Legally Authorised Person

Responsible for material checks, line clearance, packaging verification, batch release documentation, handling of scheduled substances, and complaint/adverse event handling.

• Consultants

May only be used in exceptional cases and must have documented qualifications and defined service scopes.

4.1.3 Legal Aspects

The guideline summarises key legal definitions from the Pharmacy Act and Medicines Act:

• Definitions of manufacture, responsible pharmacist, nominee, and types of pharmacies.

• Legal obligations for storage, labelling, sales, recordkeeping, advertising, and reporting of adverse events.

4.1.4 Qualifications

Employees involved in manufacturing, processing, packing, or storage must have appropriate education, training, and experience.Supervisors must be qualified to ensure products meet required quality, safety, and efficacy.An adequate number of qualified personnel must be available.

4.1.5 Training

Training is mandatory for all personnel entering manufacturing areas—including maintenance and cleaning staff. Training must cover:

• GMP principles

• Task-specific responsibilities

• Practical and theoretical knowledge

• Ongoing assessment of training effectiveness

Visitors must be supervised and given hygiene instructions.

4.1.6 Hygiene

Personal Hygiene

No eating, drinking, smoking, makeup, or false lashes in production areas.High cleanliness standards must be enforced. Direct contact with materials must be avoided.Handwashing instructions must be followed.

Area Control

All personnel must wear appropriate protective garments.Changing rooms should be available.Access to controlled areas must be restricted.

Medical Checks

Mandatory pre-employment and periodic medical examinations, with specific requirements for visual inspection staff.Staff must report infections or lesions.

5. References

The guideline references the PIC/S GMP Guideline as the primary international standard.

6. Validity

This version (v9) is valid for 5 years and replaces revision v8.

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