In any preparation for a Regulatory inspection, there is one vital tool to avoid non-compliance: the Gap Assessment. But what exactly is a Gap Assessment? On October 12th, the Technical Director of RC REDOL, Engineer Ana Gonçalves, will lecture on Sophidis Days about several themes regarding GMP’s and the Gap Assessment will be one of them.
The Gap Assessment is a comparison between the Regulatory Entities’ Guidelines and the Current Practices that take place in the production process. This comparison is done step by step, from Purchases to the delivery of Finished Products. It must go through all departments, following a methodology that begins with the identification of the areas, then the preparation of a Check List, followed by a Gap Analysis and consequent identification and classification of Gaps, their corrective actions and an implementation review.
Gap Assessment is a field of GMP (Good Manufacturing Practices) that requires a high degree of knowledge both of legislation and standards and of the Pharmaceutical Industry production realities, due to the need for interaction between these two fields. However, it is a vital analysis for the fulfilment of legal requirements. It must therefore be carried out under the eye of specialised technicians with a thorough knowledge of each area. If you need help, you should appeal to an experienced company, like RC REDOL, that has in its team the Engineer Ana Gonçalves, a specialist with a large experience in Gap Assessment in Pharmaceutical Industry.
RC REDOL, building connections!