Control of Cross-Contamination in Shared Facilities

The PIC/S Expert Circle on Controlling Cross Contamination in Shared Facilities (CCCISF) was established in 2017 further to the successful development of a PIC/S Aide Memoire on Cross Contamination in Shared Facilities (PI 043). This Expert Circle as since been active in the field of training in the use of the Aide Memoire (PI 043) and relevant sections of PIC/S GMP. The Expert Circle is also currently developing a number of other PIC/S guidance documents in the field of CCCISF.

PIC/S 1st Expert Circle on Control of Cross Contamination in Shared Facilities


Expert Circle Meeting on CCCISF, hosted by Chinese Taipei / TFDA, Taipei, 2019

Chairperson of the PIC/S Expert Circle on Control of Cross Contamination in Shared Facilities: Graeme McKilligan (UK / MHRA)

Key Features

The goals of the Expert Circle on CCCISF are to:

 

  • provide training and education in the use of the Aide Memoire and relevant sections of PIC/S GMP chapters 3 & 5 to help ensure a consistent application of expectations across PIC/S members;
  • develop awareness of the need for a proportionate approach dependent on the extent of hazards present;
  • enable ‘experts’ (trained trainers) to take training material back to their agencies for dissemination to the wider inspection teams (Expert Circle training materials to be suitable for training back at each agency);
  • promote the creation of an ‘expert’ network to share experience and knowledge on inspection of cross contamination risks and in particular understanding and assessment of health based exposure limit assessments;
  • help PIC/S Members source relevant data/contacts and information on CCCISF;
  • develop and publish a Q&A document on inspection of CCCISF for PIC/S Members use.

Past Meetings

Taipei | Chinese Taipei 2019
 

Upcoming Meetings

Expert Circle meetings and training activities are only open to Inspectors from PIC/S Participating Authorities, (Pre-)Applicants, Partners and Non-Member National Medicines Regulatory Authorities. The events are not open to Industry.

Upcoming meetings and training activities are announced under Calendar.

Training Materials

Expert Circle meeting materials are available under Materials. Login is required.