Process Validation has traditionally been considered to be the processing or packing of three consecutive replicate batches of product, and it requires, where applicable, qualified facilities, environments, equipment, utilities and operating systems, as well as validated cleaning and analytical methods, approved standard operating procedures, master batch records, trained personnel, and controlled documentation.

Because it needs to emulate routine manufacturing conditions, Process Validation is strictly the domain of the manufacturing organisation. However, we can still offer assistance in the generation of protocols, the facilitation of their execution, collation of supporting documentation and report writing. It can be a stressful time, as all participants single-mindedly focus on their own individual specific responsibilities, ever mindful that any mishaps can result in delays going to market. In such an environment, we have found the attendance of an impartial facilitator to be very beneficial, in ensuring nothing is overlooked.

Whatever you need, we can help.   CONTACT US  to find out how.