Inspectorate Directorate
Directorates
- Administration and Supply Chain
- Business Development & International Partnership
- Drug and Herbal Medicines Registration
- Enforcement
- Food Registration And Applied Nutrition
- Food Safety And Consumer Education
- Human Resource
- Industrial Services Support
- Inspectorate Directorate
- Internal Audit
- Legal and Corporate Affairs
- Medical Devices, Cosmetics And Household Chemical
- Regional Operations
- Tobacco And Substances Of Abuse
- Vaccines, Vigilance And Clinical Trials
The Inspectorate Directorate (ID) was established in December 2021 under the Technical Operations Division (TOD) of the Food and Drugs Authority. It was formed from the amalgamation of five (5) erstwhile Departments responsible for inspections and licensing namely Food Enforcement Department, Drug Inspectorate Department, Animal Products Department and the Medical Devices, Cosmetics, and Household Chemical Substance Inspectorate Department and the objective is to harmonize inspection activities across the product lines under the FDA’s mandate.
The key regulatory functions of the Inspectorate Directorate are the inspection and the licensing of manufacturing and storage facilities of regulated products under the FDA’s purview.
The Directorate derives its mandate from part 7 of the Public Health Act 2012, Act 851: that is to protect public health and safety by ensuring the availability of safe, efficacious, and quality regulated products on the Ghanaian market through inspections and licensing of manufacturing and storage facilities that fall under the purview of the FDA. The regulated products comprise allopathic medicines, veterinary medicines, vaccines, biological products, tobacco & tobacco products, herbal medicines, homoeopathic medicines, food supplements, medical devices, cosmetics, and household chemical substances.
The vision and mission of the Directorate is as per the corporate vision and mission of the FDA with a special focus on inspections and licensing.
The Inspectorate Directorate achieves its mandate through the following two Departments namely.
- Manufacturing Facility Inspectorate Department
- Storage Facility Inspectorate Department
- MANUFATCURING FACILITIES DEPARTMENT (MFD)
MFD Mandate
The Manufacturing Facilities Department (MFD) is responsible for inspection and licensing of Food, Drugs, Cosmetics, Medical Devices and Household Chemical substances manufacturing facilities. This is to ensure that manufacturing activities complies with the requirements of the current codes of Good Manufacturing Practices (cGMP). The mandate of the Manufacturing Facilities Inspectorate Department is derived from- sections of Part 7 of the Public Health Act 2012, Act 851,
Section 115: control of Manufacturing
Section 130. (1) – Registration of premises
Section 131 – Licences and permits
Section 135: Powers of an authorized officer
Section 147. (1) – (3) Regulations
Section 148. (1) – (4) Guidelines and Codes of Practice
MFD Scope of Mandate
MFD processes, inspects and grants licenses to facilities for the manufacture of regulated products and that includes allopathic medicines, veterinary medicines, vaccines, biological products, herbal medicines, homoeopathic medicines, food supplements, medical devices, cosmetics and household chemical substances.
Operational Tools
The MFD, in carrying out its mandate and daily activities, has developed the underlisted tools. These are reviewed and updated periodically when necessary to ensure they continue to be in line with international best practices.
- Guidelines
- Guidance Documents
- Standard Operating procedures
- Forms (application and operational)
The operational activities of the Department include the following:
- Receipt and management of correspondences
- Inspection scheduling
- Writing and issuing Inspection notification
- Conducting cGMP inspections
- Reviewing and responding to CAPAs emanating from inspected facilities
- Issuance of licences to inspected facilities.
- Management of inspection related databases (i.e. data base local and foreign manufacturers)
- Hold weekly Quality review meetings.
- Carry out internal Trainings.
- Meeting with other Directorates and Departments
Units are formed in the Department to support in the execution of its activities.
SFD Mandate
SFD is responsible for the inspection and licensing of Food, Drugs, Cosmetics, Medical Devices and Household Chemical substances storage facilities.This is to ensure that storage and distribution conforms to requirements of Good storage and Distribution Practices (GSDP).
The mandate of the Storage Facilities Department is derived from the following sections of Part 7 of the Public Health Act 2012, Act 851,
Section 109 Transportation of meat for sale
Section 115: control of Manufacturing
Section 130. (1) – Registration of premises
Section 131 – Licences and permits
Section 135: Powers of an authorized officer
Section 147. (1) – (3) Regulations
Section 148. (1) – (4) Guidelines and Codes of Practice
The Department processes, inspects and grants licences to facilities for the storage and distribution of regulated products for use and sale on the Ghanaian market. Regulated products include allopathic medicines, veterinary medicines, vaccines, biological products, tobacco & tobacco products, herbal medicines, homoeopathic medicines, food supplements, medical devices, cosmetics and household chemical substances on the Ghanaian market.
The SFD in carrying out its mandate and daily activities has developed the underlisted tools. These are reviewed and updated periodically when necessary to ensure they continue to be in line with international best practices.
- Guidelines
- Guidance Documents
- Standard Operating procedures
- Forms (application and operational)
The operational activities of the Department include the following:
- Receipt and management of correspondences
- Development of Inspection schedules
- Writing and issuing Inspection notification
- Conducting GDSP inspections
- Reviewing CAPAs emanating from inspected facilities
- Issuance of licences to inspected facilities.
- Issuance of Meat Transport Vehicle Licence
- Management of inspection related databases
- Maintaining register of importers
- Issuance of VAT Exemption recommendation letters for imports of selected Pharma products (LI 2255 VAT –exemption of Active Ingredients, selected drugs or pharmaceuticals- amendment Regulation 2017)
- Hold weekly Quality review meetings.
- Carry out internal Trainings.
Units are formed in the Department to support in the execution of its activities.
The following customer properties are kept by the Directorate in confidence:
- Site master file of manufacturing and storage facilities.
- Information in inspection reports emanating from GMP and GDSP inspections.
