Eye wash products fail during manufacturing process

Eye wash products fail durin" rel="nofollow">ing manufacturin" rel="nofollow">ing process Order Description Group 1: As a QP (Qualified Person) when reviewin" rel="nofollow">ing a batch record you discover that a medicin" rel="nofollow">inal product ( which is eye wash products) has been exposed to a much longer heat exposure in" rel="nofollow">in the autoclave than is normal for this product. In addition, the post filtration in" rel="nofollow">integrity test failed in" rel="nofollow">initially for this batch and the batch was refiltered before fillin" rel="nofollow">ing. Discuss the follow-up in" rel="nofollow">investigation that you would recommend for this in" rel="nofollow">incident under the headin" rel="nofollow">ings of: a) correction, b) contain" rel="nofollow">inment, c) corrective actions, d) preventive actions and e) effectiveness checks. Justify your decision-makin" rel="nofollow">ing process throughout this situation. Based on the previous scenario, Write the followin" rel="nofollow">ing: 1) Introduction and should cover: - Main" rel="nofollow">in objective. - Investigation of the problem that has already occurred. - Our product is eyewash products. 2) Discuss in" rel="nofollow">in details just one headin" rel="nofollow">ing which is a) correction, and should discuss the followin" rel="nofollow">ing: - Identify the problem. - For example method of transportation, environment, equipment used and personnel. - Gather in" rel="nofollow">information on the problem to determin" rel="nofollow">ine the cause. - Verify the problem. - Action to elimin" rel="nofollow">inate from non- conformity e.g. Changin" rel="nofollow">ing the filters or autoclave.