Context and challenges
This client is an integrated global player in pharmaceutical synthesis and specialty ingredients. This group has two production sites in Asia Bangpoo (Thailand, 20 km from Bangkok), Wuxi (China, 250 km from Shanghai) which are involved in the production of an Active Pharmaceutical Ingredient (API) in dry form (paracetamol, aspirin).
Following a Warning Letter from the FDA, the group had to implement a remediation plan, particularly for the cleaning and cleaning validation processes.
This client called on Assystem Care to define and implement a remediation plan for the cleaning scope of the two Asian production sites.
groups of equipment