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
 
1.3 Classes and types of materials

The materials to be sampled may belong to the following classes:

(a) Bulk materials, represented by:

(i) starting materials (including both drug substances and pharmaceutical aids) in solid, liquid, or semi-solid state;

(ii) vegetable drugs, such as leaves, herbs, flowers, seeds, fruits, roots, rhizomes and bark, in whole or broken state.

Special care may be needed for certain bulk materials, for example, for those that are very potent, toxic, hygroscopic, or light-sensitive, or require special microbiological precautions.

(b) Intermediates in the manufacturing process.

(c) Drug products (in-process as well as before and after packaging). For finished drug products the sampling procedure must take account of the official and nonofficial tests required for the individual dosage form (for example, tablets, parenteral preparations).

(d) Containers, packaging materials, and labels.

The sampling procedure must take account of the homogeneity and uniformity of the material.

(a) Homogeneity. A material is regarded as homogeneous when it is all of the same origin (for example, from the same batch) and as nonhomogeneous when it is of differing origins.

(b) Uniformity. A starting material may be considered uniform when samples drawn from different layers do not show significant differences in the quality-control tests. The following materials may be considered uniform unless there are signs to the contrary: organic and inorganic chemicals, purified natural products, various processed natural products like fatty oils and essential oils, plant extracts. The assumption of uniformity is strengthened by homogeneity, i.e. when the consignment is derived from a single batch.

Signs of nonuniformity include differences in shape, size or colour of particles in crystalline, granular or powdered solid substances, moist crusts on hygroscopic substances, deposits of solid material in liquid or semi-liquid products, and stratification of liquid products. Such changes, some of which may be readily reversible, can occur during prolonged storage or exposure to extreme temperatures during transportation.

Dosage forms may be considered uniform when different samples from the same batch comply with the relevant tests for uniformity.

Finally the sampling procedure must take account of the past experience with the material and with the supplier, and of the number of sampling units in the consignment.

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