18-12-2012, 06:50 PM
Sampling according to WHO guidelines for sampling of pharmaceutical products and related materials
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WHO sampling guideline - Introduction
This guideline is primarily addressed to governmental organizations such as drug regulatory authorities (including inspectorates), quality control laboratories, customs and police officials, when surveying the national markets for the quality of drug products.
The guideline is available on the internet as Annex 4 of the WHO Technical Report Series No. 929 (2005), issued by the WHO Expert Committee on Specifications for Pharmaceutical Preparations.
Preparation for sampling
Sampling tools should be available to the sampler, e.g. to open containers (knives, hammers,...), material to reclose the packages (sealing tape), self-adhesive labels to indicate that some of the contents have been removed, etc...
Sampling tools should be made of inert materials (e.g. polypropylene or stainless steel; avoid glass) and kept very clean. After use, thoroughly washed, rinsed with water or suitable solvent, dried and stored in clean conditions.
Disposable sampling materials can also be used.
Washing facilities should be located in, or close to, the sampling area.
Cleaning procedure should be documented and validated (= demonstrated efficiency).
Sterile pharmaceutical products should be sampled under aseptic conditions.
Drug quality surveillance programmes
The extent of the routine surveillance programmes for drug quality, carried out by National Drug Regulatory Authorities will depend on:
capacity of the national drug QC lab
extent to which the quality of the product has been assessed prior to registration
extent to which the requirements for GMP are implemented
number of products imported from abroad
The programme should include marketed products, whether registered for sale or prepared in pharmacies.
Each product should be assessed regularly (every 2-3 years).
Particular attention to products of prime importance to public health programmes or potentially dangerous, unstable or difficult to formulate properly.