Pharmaceutical Manufacturing and Validation

Validation is an integral part of quality assurance; it involves the systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. A validated process is one, which has been demonstrated to provide a high degree of assurance that uniform batches will be produced, that meet the required specifications and has therefore been formally approved. Validation in itself does not improve processes but confirms that the processes have been properly developed and are under controls. The processes include raw material and equipment inspections as well as in-process controls. Process controls are mandatory in good manufacturing practice (GMP). The purpose is to monitor the on-line and off-line performance of the manufacturing process, and hence, validate it. Thus validation is an integral part of quality assurance..

Verotech Engineers have been involved in pharmaceutical manufacturing process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.

We expertise in:

         Equipment validation

         Facilities validation

         HVAC system validation

         Cleaning validation

         Process validation

         Analytical method validation

         Computer System Validation

         Packaging Validation