GMP News No. 675
22 February 2006
The new PIC/S AIDE-MEMOIRE
"INSPECTION OF BIOTECHNOLOGY MANUFACTURERS"
On January 1, 2006 the PIC/S AIDE-MEMOIRE "INSPECTION OF BIOTECHNOLOGY MANUFACTURERS" has come into operation.
Like all PIC/S documents of this type it has been written for GMP-inspectors. Its purpose is to facilitate the planning and conducting of inspections. Furthermore, it should contribute to the harmonisation of GMP-inspections.
The newly published Aide-Memoire covers biotech products as well as biological products. It could also be applied to gene-therapy and cell-therapy products. It is quite noteworthy that it is explicitly mentioned in the document that its scope includes products for use in clinical trials.
The structure of the paper is very clear. In its first part, general GMP-requirements on biotechnology manufacture are outlined. Special aspects of single steps in the manufacturing process follow. The chosen format of tables makes it easy to find your way through the document. Two elements, the list of precise questions and the direct link to GMP-guidelines, are very helpful.
As the Aide-Memoire is directed towards inspectors, it is very useful for the biotech industry as well. The list of questions may be used to challenge a company's GMP-approaches step by step. Firms that are in the process of implementing GMP receive a valuable compilation of current GMP-requirements. A core benefit of this document is that it breaks down the often theoretical GMP-demands into very practical aspects.
Although the inspection list is not "all-inclusive" and varies between very detailed and very inexact recommendations, it still allows companies preparing for inspections to define answers to individual process-related questions. The list should thus help prevent substantial surprises during the next GMP-inspection.
The original document is available on the PIC/S website at the
If you would like to know what a GMP-inspector thinks about this document
and how he evaluates it based on his own inspection experiences, you
should visit ECA's GMP Conference "GMP-Compliant
Development of Biopharmaceuticals" in Copenhagen
from 15-17 May 2006.
Experienced industry experts will demonstrate how the current GMP-requirements have been implemented in their firms. The group of speakers represents big pharma as well as biotech start-ups to get input from very different perspectives.
During an included visit of the new "state-of-the-art" production site of CMC Biopharmaceuticals you can get an excellent impression how GMP-requirements are transferred into practice.