LAW ESTABLISHING THE FOOD AND DRUGS LABORATORY
Excerpts from the Public Health Act 851-2012, Part 7 of the Food and Drugs Authority, section 127 states:
1. The Authority shall have a laboratory to be known as the Food and Drugs Laboratory.
2. The Laboratory shall perform functions related to the quality of products regulated under this Part and shall in particular:
(ii) medical devices,
(iii) herbal medicinal products,
(v) raw materials,
(vi) medicine adjuvants,
(vii) packaging materials,
(viii) medicine delivery systems,
(ix) systemic diagnostic agents, and
(x) any other product that the Authority considers a product of drugs for the purposes of this Part
(ii) food packaging materials, and
(iii) raw materials used in the manufacture of food
The Food and Drugs Centre for Laboratory services and research (CLSR) has six (6) testing Laboratories and a Quality Assurance Outfit to develop, implement and maintain the Quality Management System of the centre. The Testing Laboratories include:
1. Drug Physicochemical
2. Food Physicochemical
3. Pharmaceutical Microbiology
4. Food Microbiology
5. Cosmetic / Household Chemical Substances
6. Medical Devices
The Centre's Quality Management System (QMS) is an organizational structure tailored according to the ISO/IEC 17025 standard, which consists of policies, procedures, processes, and resources used for quality management. The QMS is designed to plan, control and improve the elements that impact on the achievement of accurate and reliable test results and customer satisfaction..
The Quality Assurance Outfit of the Centre develops, implements and maintains a Quality Management System in accordance with the requirements of the International Standard-ISO/IEC 17025:2017 and WHO-GPPQCL(Good Practices for Pharmaceutical Quality Control Laboratory).
The Management System is implemented and maintained as specified in the various quality system documents. The system's documentation, under the supervision of Quality Assurance section, is communicated to, understood by, available to, and implemented by the appropriate personnel. The Outfit ensures that the laboratory personnel are fully knowledgeable in the quality management system procedures through continual training and audit processes.
Management has put in place arrangements and procedures to ensure that the entire staff is free from any undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of their work thereby diminishing confidence in its competence, impartiality, judgment or operational integrity. Clients' confidential information and proprietary rights are well protected.
The Centre's Quality System Policies and Objectives are defined in a Quality Manual which is issued under the authority of the chief executive. It includes the following:
1. The laboratory management's commitment to good professional practice and to the quality of its testing services to its clients;
2. The management's statement of the laboratory's standard of service;
3. The objectives of the quality system;
4. A requirement that all personnel concerned with testing activities within the laboratory familiarize themselves with the quality documentation and implement the policies and procedures in their work; and
5. The laboratory management's commitment to comply with ISO/IEC 17025-2017 standard and GPPQCL requirements.
The Quality Policy of the Laboratory, as approved by the Chief Executive and prominently displayed on the premises, is as stated below:
"IT IS THE POLICY OF THE LABORATORY SERVICES OF THE FOOD AND DRUGS Authority TO MAINTAIN GOOD PROFESSIONAL LABORATORY PRACTICES MEETING INTERNATIONAL STANDARDS OF TESTING WITH THE HIGHEST ACHIEVABLE ACCURACY. PERSONNEL FAMILIARIZE THEMSELVES WITH THE POLICIES/PROCEDURES AND PROVIDE TRACEABLE, HIGH-QUALITY SERVICES TO THE SATISFACTION OF THE CUSTOMERS IN CONFORMITY WITH THE APPLICABLE REQUIREMENTS OF ISO/IEC 17025:2017 INTERNATIONAL STANDARD AND WHO-GPPQCL." Certificate and Scope of Laboratory Accreditation.Click here to view
THE CENTRE'S FACILITY
Laboratory facilities for testing including but not limited to energy sources, lighting and environmental conditions, are such as to facilitate correct performance of the testing services. The facility is an adjoining two-story block towards the south of the main Food and Drugs Authority Headquarters Office complex. The Drug Physicochemical Laboratory and Cosmetic Laboratories are located at the top floor, the first floor is occupied by Pharmaceutical and Food Microbiology Laboratories and the Medical Devices Laboratory is on the ground floor. The Food Physicochemical laboratory is an off-site laboratory building located at the renovated Laboratory facility adjacent to Movenpic Ambassador Hotel and within the premises of Malaria control programme offices.
THE DRUG PHYSICOCHEMICAL LABORATORY
The Drug Physicochemical Laboratory, one of the six (6) testing laboratories of the Food and Drugs Laboratory is accredited to the ISO/IEC17025-2017 standard for testing with certificate number AT 1870 issued by ANSI-ASQ National Accreditation Board / ANAB of the United States of America, a member of ILAC.
Categories of samples tested by this Laboratory are allopathic medicines, herbal medicines, homeopathic medicines, food supplements and veterinary drugs.
The Scope of accreditation covers eleven (11) tests namely:
1. Assay by Liquid Chromatography
2. Assay by UV/Visible Spectrophotometry
3. Drug solid form dissolution
4. pH determination
5. Loss On Drying (LOD)
6. Moisture determination by Karl Fischer
7. Uniformity of Dosage Unit
8. Identification by FTIR Spectrophotometry
9. Assay by Titration
10. Assay by Polarimetry
11. Identification by Thin Layer Chromatography
The Laboratory does other tests which are not accredited.
THE MEDICAL DEVICES LABORATORY
The Medical Devices Laboratory is accredited to the ISO/IEC 17025-2017 standard for testing with certificate number AT 1870 issued by ANSI-ASQ National Accreditation Board / ANAB of the United States of America, a member of ILAC.
The Scope of accreditation covers nine (9) tests parameters on male latex condoms namely:
1. Determination of Length
2. Determination of Width
3. Determination of Thickness
4. Determination of bursting volume and pressure
5. Testing for holes
6. Determination of Visible defects
7. Testing for Package seal integrity
8. Determination of total lubricants
9. Condom sampling
The laboratory also performs tests on the under listed category of samples:
1. Female Condoms
2. Sanitary Pads
4. Intra Uterine Devices
5. Syringe and Needles
6. Diagnostic Test Kits
7. Diagnostic Devices
8. Surgical Gloves
9. Examination Gloves
10. Bandages and Adhesive Strips
11. Cotton Wool
12. Invitro administration Sets
14. Blood/Urine Bags
17. Other Personnel Protective Equipment (PPE)
THE MICROBIOLOGY LABORATORIES
The Food and Pharmaceutical Microbiology Laboratories perform microbiology analysis on products regulated under Part 7 of Public Health Act 851-2012 requiring microbiological quality evaluation.
The Food Microbiological Laboratory, accredited to ISO 17025: 2017 with certificate number AT 1870 issued by ANSI-ASQ National Accreditation Board/ANAB of the United States of America, a member of ILAC and accredited for sixteen (16) analytical tests which include the following:
*Enumeration of microorganisms (Aerobic plate count @ 30oC)
*Enumeration of coliforms
*Enumeration of faecal coliform
*Enumeration and detection of Escherichia coli
*Enumeration of Enterobacteriaceae
*Enumeration of coagulase positive Staphylococcus aureus
*Enumeration of Yeasts and Moulds
*Enumeration of Clostridium perfringens in food
*Detection of Salmonella in food and environmental samples
*Aerobic plate count in drinking water@ 220C and 370C
*Detection of Clostridium perfringens in drinking water
*Detection of Pseudomonas aeroginosa in water samples
*Enumeration of Aerobic Plate Count of food industry environmental samples
*Enumeration of Presumptive Bacillus cereus in food and animal feeding stuff
*Detection of Vibrio spp.
The Pharmaceutical Laboratory is also accredited to the ISO/IEC 17025-2017 standard for testing with certificate number AT 1870 issued by ANSI-ASQ National Accreditation Board / ANAB of the United States of America, a member of ILAC.
The scope of accreditation covers seven (7) testing areas which include:
*Total aerobic microbial count in pharmaceutical & related product and cosmetic products
*Total yeast and mould count in pharmaceutical, herbal and cosmetic products
*Sterility in applicable pharmaceutical and medical devices products
*Detection of E.coli in pharmaceutical, herbal and cosmetic products
*Detection of Salmonella in pharmaceutical, herbal and cosmetic products
*Detection of Staphylococcus aureus in pharmaceutical, herbal and cosmetic products
*Detection of Pseudomonas aeruginosa in pharmaceutical, herbal and cosmetic products
THE COSMETIC/HOUSEHOLD CHEMICAL SUBSTANCES LABORATORY
The Cosmetic/Household Chemical substances Laboratory is also accredited to the ISO/IEC 17025-2017 standard for testing with certificate number AT 1870 issued by ANSI-ASQ National Accreditation Board / ANAB of the United States of America, a member of ILAC.
The scope of accreditation covers five (5) testing areas which include:
*Identification by FTIR-Spectrophotometer
*Assay by titration
*Determination of pH
*Determination of Loss on Drying
*Assay by Spectrophotometer
The Laboratory does other tests which are not accredited.
THE FOOD PHYSICOCHEMICAL LABORATORY
The Food Physicochemical Laboratory, which is the testing laboratory for proximate analysis, Food colours, Metal analysis, Veterinary drug residue analysis and special (Mycotoxins & Pesticides residues) analysis, is located outside FDA Head office complex. It is located at the renovated old laboratory facility within the premises of the Malaria Control Programme, near the TUC office complex in Accra.
The FDA exist to ensure the safety, quality and efficacy of human and veterinary drugs, food, biological products, cosmetics, medical devices, household chemical substances and clinical trials, and the control of tobacco products through the enforcement of relevant standards to protect public health.