Equipment Validation Services

When it comes to validation, the role of the equipment or system supplier and the implication on their scope is widely misunderstood. Many customers find other suppliers charge considerable amounts of additional monies for 'validation packages' over and above the norm. This is either due to 'fear' of the unknown or unnecessary transcription of documentation. With a proper understanding of the subject, this can be avoided.

In 1987 the FDA told us that validation is 'a documented program which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes'. This states what validation should accomplish but it does not provide guidance on how to achieve and document such a program. It does show that validation is ultimately the responsibility of the customer with respect to his process. In as much as supplier's equipment affects that process, validation will have an impact on their scope of supply.

Matcon have a very clear understanding of how its scope fits into the validation 'picture'. If validation is a feature of our projects our preferred approach is as follows:

• Identify process critical functionality in each module and agree how it is to be measured. This includes operation and cleaning;
  
• Prepare project documentation in line with GAMP recommendations avoiding the need for costly reformatting;
  
• Compile material certificates and original manufacturers data-sheets from the start of project;
  
• Produce FAT, SAT, IQ and OQ protocols and assist client in execution;
  
• Assist client in generation of practical SOP's;
  
• Together with client, develop initial and ongoing training plans;
  
• Implement practical preventive maintenance schedules;