prohibited drugs
These are drugs with toxicity or side-effects that outweigh their therapeutic usefulness, so that public health and welfare are protected by prohibiting their production, manufacture, export, import, trade, distribution, supply, possession or use, except in amounts required for medical and scientific research. Prohibited drugs are normally determined by the national or supranational registration/licensing authority.

quality assurance
Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use.

quality control
Quality control covers all measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that raw materials, intermediates, packaging materials and finished pharmaceutical products conform with established specifications for identity, strength, purity and other characteristics.

unauthorized market (in some countries called parallel market)
The unauthorized market consists of wholesale establishments and retail outlets distributing or selling drugs without authorization from a competent authority.

1. Drug inspectors

1.1 Qualifications

Inspectors should normally be pharmacists who have working experience in community and/or hospital pharmacy. Where persons other than pharmacists are employed as drug inspectors, they should be adequately experienced in drug control affairs and suitably trained in inspectorate functions. The possibility of having part-time inspectors with specialist knowledge as part of inspection teams should also be considered.

The inspector should possess the following attributes:

• good knowledge of pharmacy, drugs, and poisons
• good knowledge of the laws and regulations to be enforced
• good command of technical terms and excellent communication skills
• awareness of the probable methods of using forged or false documents for transactions in pharmaceutical preparations and skill in determining the genuineness of documents presented for examination
• maturity, honesty and integrity
• responsible conduct which commands respect
• willingness to accept challenges
• ability to organize their own work with minimum supervision
• ability to assess facts quickly and take rational and sound decisions without delay
• ability to assess character and honesty of persons being interviewed
• good public relations image with key personnel/pharmacists in charge of premises while remaining firm, fair and resolute
• ability to hold discussions with company management at the completion of inspection
• ability to motivate others
• commitment to hard work and long hours
• ethical approach to any potential conflict of interest.

1.2 Organizational aspects

Inspectors should be embedded in an organization, usually called an inspectorate, which ensures the following aspects:

• A job description which describes the duties of the inspector.

• Proper reporting: inspectors should report either to the drug regulatory authority or to the pharmaceutical department (chief pharmacist) of the Ministry of Health.

• Uniformity of approach:

(a) Regular meetings of inspectors, in which experiences on the job are exchanged, will help promote a uniform approach to inspection as well as enhance the performance of the inspectors.

(b) Inspectors should work according to a work plan and to Standard Operating Procedures (SOPs).

(c) Inspection reports should preferably be in three or four parts:

(i) date of inspection and general information on the establishment inspected,

(ii) description of the inspection activities undertaken, including analytical data of samples taken,

(iii) observations and recommendations,

(iv) conclusions.

(d) Inspectors should be encouraged to submit weekly reports of work to headquarters.

• Total coverage of the country. This can be achieved by:

(a) dividing the country into defined areas for the purpose of inspection and placing an inspector in charge of a defined area for the purpose of inspecting wholesale, community and hospital pharmacies, and clinics,

(b) inspection of ports and border posts in a defined area.

• Total coverage of the field. The inspector will be expected to inspect establishments such as:

(a) pharmaceutical manufacturers in respect of drug distribution,

(b) pharmaceutical importers/exporters,

(c) pharmaceutical wholesalers and retailers,

(d) hospital pharmacies/clinics,

(e) ports and international border posts,

(f) drug warehouses, stores and unauthorized markets.

(Note: The existence of unauthorized markets for the distribution of drugs poses considerable health hazards. The inspectors should, with the assistance of task forces if necessary, investigate the extent of the unauthorized market, the types of drugs distributed and supplied, and the sources of the drugs. Where possible, unauthorized markets for drugs should be prohibited through effective inspectorate activities. Inspectors should also investigate the sources of supply of suspect counterfeit or substandard pharmaceutical products.)

• Cooperation with other agencies. The inspector will be expected to interact and cooperate with other interested parties such as:

(a) industrial, community and hospital pharmacists,

(b) management and supervisory staff of pharmaceutical establishments and hospitals,

(c) medical practitioners, dentists, veterinarians, nurses and midwives and other health workers,

(d) public analysts,

(e) ministry of justice officials and court officials,

(f) drug law enforcement officers including the police and customs,

(g) officers of port authorities, clearing agents at the ports, importers and exporters,

(h) members of the public,

(i) staff of faculties of medicine/pharmacy,

(j) foreign drug regulatory authorities.

• Independence. Inspectors should, for example, have the use of official vehicles.

• Adherence to a code of inspection.

1.3 Methods of inspection

The inspector uses different methods to check compliance with the national, supranational or international drug laws and regulations. Among these methods are:

• Comprehensive/routine inspection. This form of inspection is generally reserved for a new pharmaceutical establishment, when an establishment is applying for permit to extend its scope of operations beyond that for which it was originally licensed, has made important changes in key personnel or is changing premises, has not been inspected for a long time (3–5 years), or when there is information (even of an informal nature) of serious lapses. Where the inspection is for a new establishment or for extension of scope of operation or because of changes in key personnel, the inspection should be announced.

• Concise inspection. This is reserved for establishments that have previously been inspected with a view to assessing standards of good pharmacy practice. The outcome of the inspection will help in the proper assessment of the establishment. The inspection may be unannounced.

• Follow-up inspection. This is normally carried out to ensure that corrective measures have been undertaken following advice and notice given during a previous inspection. Where a time limit was given for applying the corrective measures, the inspection may be unannounced.

• Special inspection. This is undertaken to deal with specific complaints received about lapses or non-compliance with standards of professional practice. The inspection should preferably be unannounced.

• Investigative inspection. This type of inspection is used to assess the per- formance of a new establishment whose scope of operation was previously unknown.

Any of these methods may be applied with or without prior announcement. Normally inspections should be announced but it serves a useful purpose to undertake some unannounced inspections. Follow-up, special and investigative inspections should preferably be unannounced.

Inspections should be held regularly. Premises should be inspected at least once every 12–18 months. Where contravention is often noticed, the inspection should be more frequent (e.g. every six months). For premises with a good record, less frequent inspections may be needed.

1.4 Reference/information sources

The reference/information sources of an inspector should include:

• Existing national and international drug laws and regulations, covering such aspects as:

— licensing
— GMP
— good distribution practice
— good pharmacy practice
— promotion of pharmaceutical products
— controlled drugs
— counterfeit, spurious or substandard pharmaceutical products.

• Codes of inspection (national and regional), where in existence.

• Codes of professional ethics.

• Health consequences of drug abuse and misuse.

• Available data on imports/exports/prohibited drugs.

2. Inspection of establishments in the drug distribution chain

2.1 Broad objectives

The welfare of patients and other members of the public is of prime concern in the distribution chain of drugs, either manufactured within the country or imported. Inspections of establishments are therefore undertaken to ensure:

• Protection of patients and members of the public from malpractice by distributors and suppliers of drugs.

• Adherence to the drug laws and regulations governing compounding, distribution, importation, export and storage of drugs.

• High ethical and professional standards of pharmaceutical practice.

2.2 Establishments

In the drug distribution chain several kinds of establishments can be distinguished:

— production sites

— storage or warehouse facilities

— establishments for the supply, sale, dispensing and distribution of drugs, such as pharmacies, hospitals, clinics, ports and stores.

2.3 Inspections

When inspecting these establishments the inspector uses the appropriate references. The method of inspection should be laid down in a SOP which also contains the requirements for a specific type of establishment. The inspection SOP may be in the format of a checklist (see Appendix 1 for an example applicable to most drug distribution establishments). When sampling is part of the inspection procedure, the SOP should contain detailed guidance for the inspector; an example of this guidance is to be found in Appendix 2.

2.4 Special categories of drugs

When special categories of drugs are present the inspector may require a modified SOP. This situation is likely to occur with controlled drugs, pharmaceutical products moving in international commerce, or with counterfeit, spurious or substandard pharmaceutical products. For this last category an example of extra guidance is given in Appendix 3.