Good practices for national pharmaceutical control laboratories
General considerations:
The government, normally through the drug regulatory authority, establishes and maintains a pharmaceutical control laboratory to carry out the required tests and assays to ensure that active pharmaceutical ingredients, excipients and pharmaceutical products meet quality specifications. Throughout the process of marketing authorization, the laboratory works closely with the national drug regulatory authority. The review of test methods for newly registered drugs plays an important role in ensuring their suitability for the control of quality and safety, and requires a major effort, especially since routine drug testing must also be carried out. Some countries maintain larger establishments called “drug control centres” or “drug control institutes”.
The importance of a pharmaceutical control laboratory to a national drug control system has already been outlined in three guidelines on quality assessment (1–3).
In most countries the laboratory is responsible for analytical services only, and not for the inspection of pharmaceuticals. However, some aspects of inspection are included in these guidelines.
A governmental pharmaceutical control laboratory provides effective support for a drug regulatory authority acting together with its inspection services. The analytical results obtained should accurately describe the properties of the samples assessed, permitting correct conclusions to be drawn about the quality of each drug, and also serving as an adequate basis for any subsequent administrative regulations and legal action.
See pdf below for complete guidelines:
WHO TRS (Technical Report Series) 902, 2002 Annex 3: pdf
