WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
(1993; 36 pages) 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 activities
Open this folder and view contents3. International Chemical Reference Substances and International Infrared Reference Spectra
View the document4. Quality control methods for medicinal plant materials
View the document5. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Open this folder and view contents6. Good manufacturing practices for pharmaceutical products
View the document7. Development of globally acceptable standards for excipients
Open this folder and view contents8. Stability of dosage forms
View the document9. Simple test methodology
View the document10. Quality assurance in pharmaceutical supply systems
Open this folder and view contents11. Pharmaceutical production in developing countries
View the document12. Training
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 Spectra
Close this folderAnnex 3 - Good manufacturing practices for biological products1
View the document1. Scope of these guidelines
View the document2. Principles
View the document3. Personnel
View the document4. Premises and equipment
View the document5. Animal quarters and care1
View the document6. Production
View the document7. Labelling
View the document8. Lot processing records (protocols) and distribution records
View the document9. Quality assurance and quality control
View the documentAuthors
View the documentAcknowledgements
View the documentReferences
View the documentBack Cover
 

8. Lot processing records (protocols) and distribution records

8.1 Processing records of regular production lots must provide a complete account of the manufacturing history of each lot of a biological preparation, showing that it has been manufactured, tested, dispensed into containers and distributed in accordance with the licensed procedures.

8.2 A separate processing record should be prepared for each lot of biological product, and should include the following information:

- the name and dosage of the product;

- the date of manufacture;

- the lot identification number;

- the complete formulation of the lot, including identification of seed or starting materials;

- the batch number of each component used in the formulation;

- the yield obtained at different stages of manufacture of the lot;

- a duly signed record of each step followed, precautions taken and special observations made throughout the manufacture of the lot;

- a record of all in-process control tests and of the results obtained;

- a specimen of the label;

- identification of packaging materials, containers and closures used;

- a dated signature of the expert responsible for approving the manufacturing operations;

- an analytical report, dated and signed by the responsible expert, showing whether the lot complies with the specifications described in the standard operating procedure registered with the national control authority;

- a record of the decision regarding the release or rejection of the lot by the quality control department and, if the lot is rejected, a record of its disposal or utilization.


8.3 The records shall be of a type approved by the national control authority. They shall be retained for at least two years after the expiry date of a lot or batch of a biological product and be available at all times for inspection by the national control authority.

8.4 Records must make it possible to trace all steps in the manufacture and testing of a lot, and should include records of sterilization of all apparatus and materials used in its manufacture. Distribution records must be kept in a manner that permits rapid recall of any particular lot, if necessary.

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