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:

The Authority shall have a laboratory to be known as the Food and Drugs Laboratory. The Laboratory shall perform functions related to the quality of products regulated under this Part and shall in particular:

(a) analyse

(i) drugs,

(ii) medical devices,

(iii) herbal medicinal products,

(iv) cosmetics,

(v) raw materials,

(vi) medicine adjuvants,

(vii) packaging materials,

(viii) medicine depvery systems,

(ix) systemic diagnostic agents, and

(x) any other product that the Authority considers a product of drugs for the purposes of this Part

(b) analyse

(i) foods,

(ii) food packaging materials, and

(iii) raw materials used in the manufacture of food

LABORATORY MANAGEMENT STRUCTURE / SYSTEM

The Laboratory currently has seven (7) Units; six (6) testing units and a Quality Assurance Unit. The Testing Units include:

Drug Physicochemical

Food Physicochemical

Pharmaceutical Microbiology

Food Microbiology

Cosmetic / Household Chemical Substances

Medical Devices

The Laboratory’s Quality Management System (QMS) is an organizational structure tailored according to the ISO/IEC 17025 standards, which consists of procedures, processes and resources used for quality management. It is designed to increase performance and quality within the laboratory.

QUALITY ASSURANCE UNIT

The Quality Assurance Unit of the Food and Drugs Authority Laboratory develops and implements a Quality Management System in accordance with the requirements of the International Standard – ISO/IEC 17025:2005 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 this unit, is communicated to, understood by, available to, and implemented by the appropriate personnel. The unit ensures that the laboratory personnel are fully knowledgeable in the quality management system procedures through continual training and audit processes.

The management have put in place arrangements and procedures to ensure that the entire staff is free fromany undue internal and external commercial, financial and other pressures and influences that may adverselyaffect the quality of their work thereby diminishing confidence in its competence, impartiality, judgement oroperational integrity. Clients’ confidential information and proprietary rights are well protected.

The laboratory’s Quality System Policies and Objectives are defined in a Quality Manual which is issued underthe 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 to ISO/IEC 17025-2005 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 17025:2005 INTERNATIONAL STANDARD AND WHO-GPPQCL.”

LABORATORY 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-storey 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, first floor is occupied by Pharmaceutical and Food Microbiology Laboratories and the Medical Devices Laboratory is at the ground floor. The Food Physicochemical laboratory is located at the newly renovated laboratory building at the old site adjacent to Movenpic Ambassador Hotel and within the premises of Malaria control programme offices.

Drug Physicochemical Laboratory

Medical Devices Laboratory

Microbiology Laboratories

Cosmetic/Household Chemical Substances Laboratory

Food Physicochemical Laboratory