WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Close this folderAnnex 6. Guidelines for inspection of drug distribution channels
View the documentIntroductory note
View the documentGeneral considerations
View the documentGlossary
Open this folder and view contents1. Drug inspectors
Open this folder and view contents2. Inspection of establishments in the drug distribution chain
View the documentReferences
View the documentSelected further reading
View the documentAppendix 1. Checklist for inspection and the preparation of a report
View the documentAppendix 2. Guidance on sampling
View the documentAppendix 3. Guidance for inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard
View the documentAppendix 4. Sample receipt form
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover


The definitions given below apply to the terms used in these guidelines. They may have different meanings in other contexts.

A defined quantity of any drug product processed in a single process or series of processes such that it can reasonably be expected to be uniform in character and quality.

batch number1
A distinctive combination of numbers and/or letters which specifically identifies a batch on the labels, the batch records, the certificate of analysis, etc.

1 As defined in "Good manufacturing practices for pharmaceutical products" (1).


controlled drugs
Narcotic drugs and psychotropic substances regulated by provisions of national drug laws.

counterfeit pharmaceutical product
A pharmaceutical product which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients, with the wrong ingredients, without active ingredients, with an insufficient quantity of active ingredient or with fake packaging.

drug (pharmaceutical product)
Any substance or mixture of substances that is manufactured for sale or distribution, sold, supplied, offered for sale or presented for use in:

(i) the treatment, mitigation, cure, prevention or diagnosis of disease, an abnormal physical state or the symptoms thereof and abnormal physiological conditions in human or animal; or


(ii) the restoration, correction or modification of organic functions in human or animal.


finished pharmaceutical product
A pharmaceutical product that has undergone all stages of production and quality control, including being packaged in its final container and labelled.

good manufacturing practice1
Good manufacturing practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.

1 As defined in "Good manufacturing practices for pharmaceutical products" (1).


good pharmacy practice
The practice of pharmacy aimed at providing and promoting the best use of drugs and other health care services and products, by patients and members of the public. It requires that the welfare of the patient is the pharmacist's prime concern at all times.

over-the-counter drugs
These are drugs that can be sold from licensed dealers without professional supervision and without prescriptions. These drugs are suitable for self-medication for minor diseases and symptoms.

A pharmacist is a holder of a degree or diploma in pharmacy from a recognized higher institution of learning and is registered or licensed to practise pharmacy.

pharmacy-only drugs
These are drugs authorized to be sold only in licensed pharmacies under the supervision of licensed and registered pharmacists; they may be sold without a prescription.

A preparation or substance defined by a national drug law as a poison.

prescription-only drugs
These are drugs supplied only in licensed pharmacies on the presentation of signed prescriptions issued by a licensed and registered medical practitioner, licensed and/or registered dentist (for dental treatment only), and/or licensed and/or registered veterinarian (for animal treatment only), and the supply and dispensing of these drugs must be carried out by a pharmacist or under the supervision of a pharmacist. Prescription drugs are further subdivided into controlled drugs (narcotic drugs and psychotropic substances) and non-controlled drugs.

product recall
Product recall is a process for withdrawing or removing a pharmaceutical product from the pharmaceutical distribution chain because of defects in the product or complaints of serious adverse reactions to the product. The recall might be initiated by the manufacturer/importer/distributor or a responsible agency.

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 assurance1
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.

1 As defined in "Good manufacturing practices for pharmaceutical products" (1).


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.

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