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
Close this folder6. Documentation
View the document6.1 General
View the document6.2 Specifications
View the document6.3 Batch production records
View the document6.4 Other documents
Open this folder and view contents7. Good practices in production and quality control
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
 

6.1 General

The excipient manufacturer should have a system to cover all documents and data that relate to the requirements of the quality system. Documents, and subsequent changes to the documents, should be reviewed and approved by designated personnel before being issued to the appropriate areas identified in the documents. A record should be kept of where the documents are located.

The following minimal requirements for documentation should be applied:

• To assign a unique batch number to the excipient to be released and/or certified.

 

• To prepare a batch record.

• To demonstrate that the batch has been prepared under GMP conditions from the processing point at which excipient GMP have been applied.

• To demonstrate that the batch is homogeneous within the manufacturer's specifications. This does not require a final blending of continuous process material, if process controls can demonstrate compliance with specifications throughout the batch.

• To demonstrate that the batch has not been commingled with material from other batches for the purpose of either hiding or diluting an adulterated substance.

• To demonstrate that the batch has been sampled in accordance with a sampling plan that ensures a representative sample of the batch is taken.

• To demonstrate that the batch has been analysed using scientifically established tests and methods designed to ensure that the product meets accepted standards and specifications for quality, identity and purity.

• To demonstrate that the batch has stability data to support the intended period of use; these data can be obtained from actual studies on the specific excipient or from applicable "model product" stability studies that can reasonably be expected to simulate the performance of the excipient.

 

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