Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Close this folder6. Laboratory services
Open this folder and view contentsNational laboratories for drug quality surveillance and control1
Open this folder and view contentsGood laboratory practices in governmental drug control laboratories1
Close this folderSampling procedure for industrially manufactured pharmaceuticals1
Close this folder1. General considerations
View the document1.1 Purpose of sampling
View the document1.2 Types of controls
View the document1.3 Classes and types of materials
View the document1.4 Parties concerned with sampling procedures
Open this folder and view contents2. Use of terms
View the document3. General precautions to be taken during sampling operations
View the document4. Packaging and labelling of samples
View the document5. Sampling during pharmaceutical inspections
View the document6. Sampling of pharmaceutical dosage forms in regular surveillance programmes on drug quality during marketing
View the document7. Sampling of pharmaceutical dosage forms for acceptance of consignments
Open this folder and view contents8. Sampling of starting materials
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
 
1.4 Parties concerned with sampling procedures

Parties concerned with sampling procedures include:

(a) manufacturers, in the context of good manufacturing practice (GMP);

(b) customers, such as governmental or nongovernmental agencies involved in the acquisition of drug products;

(c) drug control authorities, responsible for the clearance of drug products held in quarantine after manufacture or importation, and for the detection of materials that have deteriorated or have been contaminated or adulterated.

These guidelines are intended primarily for drug control authorities and governmental procurement agencies, but the general principles may also be appropriate for the other parties referred to above.

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