SAHPRA GMP Compliance: Addressing Allegations Against Adcock Ingram’s Clayville Facility

By HEOR Staff Writer

February 25, 2026

SAHPRA GMP compliance at Adcock Ingram’s Clayville facility has been reaffirmed by the South African Health Products Regulatory Authority (SAHPRA) in its press release dated 23 February 2026. This directly addresses a Carte Blanche report aired on 22 February 2026, featuring whistleblower claims of Good Manufacturing Practice (GMP) issues, especially on the Citro-Soda lemon flavour line. SAHPRA’s routine inspections from August 2023 to October 2024, including unannounced visits, found no risks to product quality or patient safety, resulting in a GMP licence in March 2025. The authority stresses handling credible complaints via formal channels, highlighting ongoing SAHPRA GMP compliance without evidence of non-compliance.

Inspections Expose and Resolve GMP Gaps

SAHPRA’s inspection records show proactive steps on GMP matters. The August 2023 check flagged corrective and preventive actions (CAPAs) for sterile eye drops and oral forms, confirmed compliant by June 2024. Issues in liquids, powders, and tablets led Adcock Ingram to pause production voluntarily, with fixes verified in October 2024—directly refuting claims of faulty ventilation, crumbling belts, rusty gear, and hygiene lapses. An unannounced April 2025 visit, prompted by a complaint on unhygienic conditions, examined Citro-Soda batches and packaging, finding clean microbiological results and just a minor cleaning log gap, swiftly fixed. These steps affirm SAHPRA GMP compliance through issue spotting to resolution.

SAHPRA’s methods follow the Medicines and Related Substances Act 101 of 1965, using scheduled GMP checks, CAPA reviews, voluntary halts, and surprise audits to guarantee quality, safety, and efficacy. Coverage included sterile and oral production like Citro-Soda, with tests debunking contamination from wastewater or dust. Quick action on the April 2025 tip, despite no complainant contact, bolsters SAHPRA’s rejection of safety risks.

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