Inspection Management

As pharmaceutical companies face more and more inspections, the requirements to effectively prepare for these inspections and develop efficient methods to achieve successful results is also increasing. 

The spectrum of inspections is vast, from internal company audits and mandatory self-inspection in accordance with the EU GMP Guidelines, to global monitoring and inspections by regulatory authorities. 

Quality Pharma Projects objective is to determine through official publications deficiencies and trends among industry-wide audits and subsequently establish which specific preparations are needed.  The following documentation of quality assurance measures during every inspection is highly relevant:

• Contamination Control Strategy

• Deviation and Complaints

• Change Control System

• CAPAs (Corrective Action Preventive Action)

• Responsibility Elimination Agreement

• Production Status

• Distribution

Topics such as change control system, change documentation, qualification and life cycle processes are all closely associated with inspection management within the guidelines of Regulatory Compliance and GMP Compliance and thus must be included in the preparation of an inspection.