NAFDAC GMP FOR PHARMACEUTICAL PRODUCTS
Act · Health
Guidelines establish good manufacturing practices for pharmaceutical products to maintain consistent quality and safety. They target pharmaceutical manufacturers and quality assurance professionals to implement proper standards. This ensures drugs meet international quality requirements.
What Is This Policy?
Guidelines establishing Good Manufacturing Practice standards for pharmaceutical product manufacturing in Nigeria, ensuring consistent quality and safety in drug production.
Who Does It Target?
Pharmaceutical manufacturers, quality assurance professionals, regulatory inspectors, and the pharmaceutical industry.
What Does It Aim to Achieve?
Ensure pharmaceutical products are consistently produced and controlled to quality standards appropriate to their intended use, in line with WHO GMP guidelines.
Key Features
Quality Management: Mandates comprehensive quality management systems in manufacturing facilities. Facility Standards: Specifies requirements for premises, equipment, and environmental controls. Personnel Qualifications: Defines qualification and training requirements for manufacturing staff. Documentation: Requires detailed documentation of all manufacturing processes and quality controls.
Current Status
Rollout Stage: Active and enforced through regular inspections. Coverage: All pharmaceutical manufacturing facilities in Nigeria. Funding: NAFDAC regulatory fees and inspection budgets.
How to Access
Manufacturers must implement GMP and undergo NAFDAC inspections. Implement GMP systems in manufacturing facility Apply for NAFDAC GMP certification Undergo periodic inspection and audits Portal: nafdac.gov.ng
Important Terms
Non-compliance may result in facility closure, product recall, or prosecution.
Impact & Metrics
Ensures Nigerians have access to safe, quality pharmaceutical products.
Official Resources
Website: https://www.nafdac.gov.ng Contact: NAFDAC Headquarters, Abuja
Legal Framework
Issued under the National Agency for Food and Drug Administration and Control Act 1993 (as amended). Operates alongside the Food and Drugs Act Cap F32 LFN 2004, the Pharmacists Council of Nigeria Act, the ICH Good Manufacturing Practice guidelines, WHO prequalification standards, and the Falsified Medicines guidelines adopted by Nigeria.