Last week, I published a blog titled “Dedicated facilities or not?” and I surmised that trying to guess where regulations on cross-contamination were going, it was like gazing into a crystal ball. Well, the crystal ball was in Paris two weeks ago where 156 participants from 56 countries met on the topic of “Dedicated Facilities”. The aim of the seminar was to discuss the potential cross-contamination risks of manufacturing toxicologically sensitive products in a shared facility, and the impact that this has for public health and industry decisions. The seminar comprised of a series of lectures, presentations and workshops, and covered topics such as:
- Movement of personnel between dedicated and non-dedicated facilities and the impact
- Manufacture of veterinary products in dedicated and non-dedicated facilities
- Using the risk management approach as detailed in ISPE Risk MaPP
- A workshop on the introduction of a new active substance to a non-dedicated facility, and looking at cross-contamination due to airborne transfer.
As a result of the seminar, Inspectors agreed to establish a PIC/S Expert Circle on Dedicated facilities, who will be responsible to publish an Aide Memoire. It is intended that this document will cover the inspection of dedicated facilities and focus on harmonization of terminology and provide a platform for inspectors that will be internationally acceptable.
The press release from PIC/S yesterday also highlighted that the PIC/S Committee agreed to work with the EMA Working Group on GMDP on the revision of Annex 1 (sterile manufacture) of the PIC/S-EU GMP guide.
There is certainly a lot of activity within PIC/S at the moment with Croatia/HALMED applying for membership back in September, Brazil/ANVISA completing its membership application, and PIC/S assessment visits in Hong Kong, Iran and Turkey in 2015.
This topic will continue to be of interest to us in the industry for some time to come – I will continue my crystal ball gazing.