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
Close this folderAnnex 4. Good manufacturing practices: authorized person - role, functions and training
View the document1. The role and position of the authorized person in the company
View the document2. Implementation of the quality system
View the document3. Routine duties of an authorized person
View the document4. Education and training
View the document5. Selected references
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
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
 

2. Implementation of the quality system

Authorized persons have a personal and professional responsibility for ensuring that each batch of finished products has been manufactured in accordance with the marketing authorization, GMP rules and all related legal and administrative provisions. This does not necessarily mean that they must have directly supervised all manufacturing and quality control operations. They must be satisfied either directly or, more usually, by proper operation of quality systems, that manufacturing and testing have complied with all relevant requirements. Therefore it is recommended that the manufacturer establishes and maintains a comprehensive quality system, covering all aspects of GMP.

Useful reference material, in addition to rules and regulations on GMP, may be found in the International Standards ISO 9000 family (9000-9004). These standards describe quality systems requirements that can be used for external quality assurance purposes. The important element of these documents is a quality manual, describing the quality policy and objectives (commitment to quality) of the company, the organizational structure, responsibilities and authorities, together with a description of or references to documented quality system procedures.

Research and development activities and the transfer of results of the developmental work to routine manufacture, including original product design, formulation, processes development and validation, should observe GMP principles as guidance. Batches produced for clinical trials must follow applicable GMP. It is of vital importance that the quality of routine production batches corresponds to a specification derived from the composition of development batches. The quality and safety of a pharmaceutical product depend on the application of appropriate procedures, based on GMP, leading to a product within the recognized specification. Standard procedures and recognized specifications cannot be separated.

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