Inspection Management

Audits and inspections (self, external, and regulatory authorities) are fundamental elements of managing quality in the pharmaceutical industry. Pharmaceutical companies are governed by regulations, hence regulatory inspections and their management is very important.

Every pharmaceutical product-manufacturing firm must follow the regulations and/or regulatory guidelines of the country where they are authorized to sell their products. Generally, the regulatory authority inspects the manufacturing site of the pharmaceutical company before giving a manufacturing license or approving the site for manufacturing products for the relevant country. Manufacturing license or approval of manufacturing site depends on satisfactory inspection outcome. Appropriate inspection management is necessary to get a satisfactory inspection outcome.

With hundreds of inspections management under our experienced belt, we can help you with a decisive inspection plan for any planned and unplanned inspections. From the inspection approach (expectations of inspecting agency or your internal QMS requirements), team building, assessing skills to post inspection response preparation, regulatory meeting preparation, CAPA plans and effectiveness checks, count on us for Excellency in execution.