NAFDAC Guidelines for Pre-Production Inspection of Pharmaceutical Manufacturing Facilities in Nigeria

Guidelines outline inspections for new pharmaceutical manufacturing facilities before production starts to verify GMP compliance. They target regulated entities, inspection teams, and industry stakeholders. This guarantees that facilities meet quality standards for safe medicines.

What Is This Policy?

Guidelines for the inspection of new pharmaceutical manufacturing facilities before they begin commercial production, verifying GMP compliance and readiness.

Who Does It Target?

Regulated entities as applicable NAFDAC inspection and compliance teams Industry stakeholders

What Does It Aim to Achieve?

Ensure new pharmaceutical factories meet quality standards before producing medicines for the Nigerian market.

Key Features

Facility Readiness: Completed construction, equipment installation, and utility qualification GMP Compliance: Assessment against current Good Manufacturing Practice standards Quality System: Documentation of quality management system, SOPs, and validation protocols Personnel Readiness: Qualified staff in place with completed training

Current Status

Rollout Stage: Active Coverage: All applicable regulated entities Lead Agency: NAFDAC

How to Access

Regulated entities must comply with these guidelines. Complete facility construction and equipment qualification Prepare quality management documentation Request NAFDAC pre-production inspection

Official Resources

Website: nafdac.gov.ng Contact: NAFDAC, 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.