Basic Risk Analysis (BRA) is conducted in the conceptual design stage of a project. In the course of a Basic Risk Analysis the production facility/department/area is considered as a whole entity, whereby a general GMP-compliance and risk analysis is performed for the developed hygienic zones concept (layout), material and personnel flows, process and auxiliary equipment, and the process itself.
Results of Basic Risk Analysis, first approved versions of layouts and a list of equipment are the basis for the preparation of Validation Master Plan (VMP) which defines the policy for qualification / validation activities, responsible persons, documentation format, equipment / systems to be qualified (Qualification Matrix) and processes / methods to be validated.
In the course of a Detailed Risk Analysis (RA) are considered in detail possible risks that are connected to individual systems or equipment units, and also compliance to GMP requirements of equipment design specifications provided by its manufacturer.
Pharma Group Baltic offers:
Conducting Risk Analysis (GMP RA, FMEA, HAZOP)
Assistance/support in Risk Analysis conduction by the Clients specialists
Checking Risk Analysis conducted by the Clients specialists