NAFDAC Good Manufacturing Practice Guidelines for Pharmaceutical Products 2016
Guideline · Health
Policy date: 2016-01-01
Guidelines establish comprehensive standards for good manufacturing practices in pharmaceutical production in Nigeria, aligned with WHO requirements and covering processes from material receipt to product release. These guidelines target regulated entities, NAFDAC teams, and industry stakeholders. They aim to ensure medicines are consistently produced and controlled to meet quality standards for their intended use.
NAFDAC Good Manufacturing Practice Guidelines for Pharmaceutical Products 2016
What Is This Policy?
Comprehensive GMP guidelines for pharmaceutical manufacturing in Nigeria, aligned with WHO GMP standards, covering all aspects of medicine production from materials receipt to product release.
Who Does It Target?
Pharmaceutical manufacturers and contract manufacturers in Nigeria; importers of finished medicines and active pharmaceutical ingredients; NAFDAC inspection and registration teams; quality assurance and quality control personnel in the pharmaceutical industry
NAFDAC teams Industry stakeholders
What Does It Aim to Achieve?
Ensure that medicines are consistently produced and controlled to quality standards appropriate to their intended use.
Key Features
Quality Management: Quality policy, quality assurance, quality control, and quality risk management Premises and Equipment: Design, qualification, and maintenance of manufacturing facilities and equipment Production: Documentation, process validation, and in-process controls Validation: Process, cleaning, and analytical method validation requirements Self-Inspection: Internal audit programmes to monitor GMP compliance
Current Status
Rollout Stage: Active Coverage: All applicable entities Lead Agency: NAFDAC
How to Access
Regulated entities must comply. Implement comprehensive quality management system Validate all critical processes Maintain GMP compliance through self-inspection
Official Resources
Website: nafdac.gov.ng Contact: NAFDAC, Abuja
Legal Framework
The NAFDAC Good Manufacturing Practice Guidelines for Pharmaceutical Products are issued under the NAFDAC Act. They operate alongside the Pharmacy Council of Nigeria Act, the National Drug Policy, and the Standards Organisation of Nigeria Act. International alignment is with WHO Good Manufacturing Practices (GMP) guidelines for pharmaceutical products, the ICH Q7 GMP Guidance, the PIC/S Guide to GMP, and NAFDAC's alignment with the African Medicines Regulatory Harmonization (AMRH) programme standards.