RT Journal Article
SR Electronic
T1 Contamination Control Strategy (CCS), Check! Now What? Lifecycle Management of CCS
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 751
OP 752
DO 10.5731/pdajpst.2024.99901
VO 78
IS 6
A1 Chan, Hilary
YR 2024
UL http://journal.pda.org/content/78/6/751.abstract
AB Establishing a Contamination Control Strategy (CCS) is a requirement per EU Annex 1 (Aug 2022).  Once a CCS is established, the challenge becomes; “how do I ensure appropriate lifecycle management and effectiveness monitoring for my CCS?”  According to Annex 1, “The CCS should be actively reviewed and, where appropriate, updated and should drive continual improvement of the manufacturing and control methods. Its effectiveness should form part of the periodic management review.”  This presentation will provide examples of how a pharma company is integrating CCS review into existing quality management system processes to ensure CCS remains updated and accurate.  Additionally, the use of tools to automate and digitize monitoring of the effectiveness of CCS will be presented.