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GMP Guidelines

Good Manufacturing Practice (GMP) is that part of quality assurance which ensures that regulated products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by their marketing authorisations. It ensures that regulated products are manufactured so that they are fit for their intended use, comply with the requirements of the marketing authorisations and do not place the populace at risk.

 

RISK CATEGORIZATION OF FOREIGN MANUFACTURING FACILITIES

INTRODUCTION

In line with NAFDAC’s continued efforts to streamline its operations for efficient service delivery, the Agency is deploying a risk-based approach to the conduct of GMP inspection of foreign manufacturing facilities.

This categorization has become necessary to allow proper planning for the conduct of quality audits of these facilities and will also ensure that facilities with higher risk categorization are scheduled and inspected first while those with lower risk categorization are inspected at a later date

To this end, foreign manufacturing facilities will be categorized into four (4) levels with Level 4 having the highest risk level and Level 1 having the lowest based on the following criteria:

LEVEL 1

  1. Facilities operating in countries having Stringent Regulatory Authorities1.
  2. Multinational companies/Global brands.
  3. Facilities having World Health Organization (WHO) GMP certification/Prequalified product.
  4. Facilities operating in a Pharmaceutical Inspection Cooperation Scheme (PIC/S) member country (https://www.picscheme.org/en/members).

LEVEL 2

  1. Facilities with history of more than Two (2) satisfactory NAFDAC GMP audits.

LEVEL 3

  1. Facilities that have had one satisfactory NAFDAC GMP audit.

LEVEL 4

  1. No history of NAFDAC GMP audit and not falling in category 1 above.
  2. History of unsatisfactory NAFDAC GMP audit or major deficiencies.
  3. International alerts or product recalls from the facility.
  4. Country categorization based on historic trends e.g. NAFDAC inspection history or other regulatory decision(s).

Marketing Authorization for applications from facilities in Levels 1 & 2 are to be granted while the inspection of these facilities by NAFDAC will be conducted at a later date.

Registration applications from facilities in Levels 3 & 4 will not be presented for approval until the facilities have been inspected by NAFDAC and the GMP is found satisfactory.

Facilities can migrate between levels based on the outcome of the NAFDAC inspection whilst two (2) unsatisfactory GMP audits of a facility will lead to inability to grant Marketing Authorization for products manufactured in those facilities.

In view of the foregoing, there is a need to obtain information on the status of foreign manufacturing facilities and as such, applicants for product registration will be required to provide necessary information on their intended manufacturers to enable categorization of the facilities. This is to be done through the completion of the Facility Status Verification Form at the point of submission of the registration application. These forms are to be forwarded to the relevant Inspection Directorates for categorization of the facilities. Applicants are to provide verifiable objective evidence for any claims made to support the categorization of their intended manufacturers.

1Stringent Regulatory Authorities

“A regulatory authority which is:

  1. A member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labor and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency; or
  2. An ICH observer, being the European Free Trade Association, as represented by Swissmedic, and Health Canada; or
  3. A regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement, including Australia, Iceland, Liechtenstein and Norway.

The completed form should be returned via email to the relevant inspecting Directorate:

Drug Evaluation & Research:  This email address is being protected from spambots. You need JavaScript enabled to view it.

Veterinary Medicines & Allied Products:  This email address is being protected from spambots. You need JavaScript enabled to view it.

Food Safety and Applied Nutrition: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

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