PIC/S GMP Guide

PIC/S’ best manufacturing practice guide for hospital pharmacies and medicines dispensaries

The Pharmaceutical Inspection Cooperation Scheme, PIC/S, has published a best manufacturing practice guide for healthcare service providers, aimed particularly at hospital pharmacies and medicines dispensaries. The guide can be downloaded at the PIC/S website.

Many countries allow hospital pharmacies and medicines dispensaries to manufacture small quantities of medicines for their own use without the requirement for marketing authorisation. The current EU Guidelines to Good Manufacturing Practice have been drawn up for medicines under marketing authorisation produced at an industrial scale. The PIC/S guide (PE 010-2) contains more detailed and practical examples of best manufacturing practice for manufacture in the hospital pharmacy and medicines dispensary setting.

The PIC/S guide sets out the best manufacturing practice for healthcare establishments and ”reflects the current state of the art”. The guide acknowledges that there are acceptable methods, other than those described in the Guide, which are capable of achieving the principles of the Guide. It further notes that the Guide is not intended to place any restraint upon the development of alternate systems, new concepts or new technologies, which provide a level of Quality Assurance at least equivalent to those set out in this Guide.

Under Finnish law, hospital pharmacies and medicines dispensaries are required to observe the principles of best manufacturing practice when producing medicines. The PIC/S guide will offer support and guidance to professionals in implementing this requirement in everyday practice.

Guidance and advice on best medicines manufacturing practice for hospital pharmacies and medicines dispensaries is available from the Finnish Medicines Agency (Fimea).