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
 

3. Routine duties of an authorized person

Before approving a batch for release the authorized person doing so should always ensure that the following requirements have been met:

• The marketing authorization and the manufacturing authorization requirements for the product have been met for the batch concerned.

 

• The principles and guidelines of GMP, as laid down in the guidelines published by WHO, have been followed.

• The principal manufacturing and testing processes have been validated, if different.

• All the necessary checks and tests have been performed and account taken of the production conditions and manufacturing records.

• Any planned changes or deviations in manufacturing or quality control have been notified in accordance with a well-defined reporting system before any product is released. Such changes may need notification to and approval by the drug regulatory authority.

• Any additional sampling, inspection, tests and checks have been carried out or initiated, as appropriate, to cover planned changes and deviations.

• All necessary production and quality control documentation has been completed and endorsed by supervisors trained in appropriate disciplines.

• Appropriate audits, self-inspections and spot-checks are being carried out by experienced and trained staff.

• Approval has been given by the head of the quality control department.

• All relevant factors have been considered, including any not specifically associated with the output batch directly under review (e.g. subdivision of output batches from a common input, factors associated with continuous production runs).

 

In certain circumstances the authorized person may be responsible for the release of intermediates manufactured on contract.

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