Gap analysis

A Gap analysis is carried out in order to identify and document possible "gaps" and weak points in the GMP documentation and to suggest ways and means for rectification so that GMP compliance is guaranteed.

This may comprise the following:

• Components
• Equipment
• Systems
• Processes
• Plants
• Department standards and procedures
• Location specifications
• Documentation
• Company policies

Risk analysis

It is the goal of a risk analysis to identify critical process steps and functions as well as to analyze and evaluate them with regard to product quality and patient safety.

We can support you with the risk analysis as follows:

• Determination of qualification scope and depth
• Identification of parameters which are relevant to quality and process critical
• Detection of possible risks applying the following methods:
  • Failure mode and effect analysis (FMEA)
  • Hazard analysis and critical control points (HACCP) or
  • Modifications of these methods