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

Guidelines outline the inspection process for pharmaceutical manufacturing facilities in Nigeria to ensure they comply with Good Manufacturing Practices before product registration. They target manufacturers, NAFDAC inspectors, and industry stakeholders. This verifies that facilities meet safety standards for public health.

What Is This Policy?

Guidelines for inspecting pharmaceutical manufacturing facilities as a prerequisite for registering the products they manufacture, ensuring GMP compliance at the point of product registration.

Who Does It Target?

Regulated entities as applicable NAFDAC inspection and compliance teams Industry stakeholders

What Does It Aim to Achieve?

Verify that manufacturing facilities meet GMP standards before their products are registered for sale in Nigeria.

Key Features

GMP Assessment: Comprehensive GMP audit of the facility, equipment, and systems Product-Specific Review: Assessment of manufacturing capability for the specific products being registered Documentation Review: Master batch records, validation reports, and quality control procedures Corrective Actions: Process for addressing deficiencies identified during inspection

Current Status

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

How to Access

Regulated entities must comply with these guidelines. Prepare facility for GMP inspection Submit product registration application triggering facility inspection Address any deficiencies identified

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.