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
Close this folderAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
View the document1. General considerations
View the document2. Glossary
View the document3. Self-inspection and quality audits
Open this folder and view contents4. Equipment
Open this folder and view contents5. Materials
Open this folder and view contents6. Documentation
Close this folder7. Good practices in production and quality control
View the document7.1 Change control and process validation
Open this folder and view contents7.2 Good practices in production
Close this folder7.3 Good practices in quality control
View the document7.3.1 General
View the document7.3.2 Control of starting materials
View the document7.3.3 In-process testing
View the document7.3.4 Quality records and retention samples
View the document7.3.5 Stability studies
View the document7.3.6 Expiry/re-evaluation dating
View the document7.3.7 Calibration of measuring and test equipment
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
 
7.3.4 Quality records and retention samples

The manufacturer should establish and maintain procedures for identification, collection, indexing, filing, storage, maintenance and availability of quality records. Quality records should be maintained to demonstrate achievement of the required quality and the effective operation of the quality system. These data should include pertinent subcontractor quality records.

All quality records should be legible and identifiable to the product involved. Quality records should be stored and maintained in such a way that they are readily retrievable, in facilities that provide a suitable environment to minimize deterioration or damage and to prevent loss. Retention times of quality records should be established and recorded. Where agreed contractually, quality records should be made available for evaluation by the purchaser or the purchaser's representative for an agreed period.

All appropriate records relating to inspection and testing must be available for review. Where the process is continuously monitored, acknowledgement must be made of this and the results of the monitoring should be available.

Reserve samples of the released excipient should be retained for one year after the expiry or re-evaluation date, or for one year after distribution is complete. Sample size should be twice the amount required to perform release specification testing.

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: August 29, 2014