Validation and Qualification?

Have you got it Covered, Week 3 
Much confusion surrounds the terms ‘Qualification’ and ‘Validation’ when it comes to good coolchain practice. The terms ‘validation’ and ‘qualification’ are often used interchangeably and both relate, essentially, to the process of proving that a process or equipment is ‘fit for purpose’. Certainly the most important thing of all is to ensure that something is fit for purpose rather than get bogged down in semantics.

However, the International Conference on Harmonisation (ICH) provides the following definitions which are mirrored in the latest EU GMP guideline:

Qualification
The action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.

Validation
A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria.

What this means in practice is that all components or equipment used in a ‘validated’ coolchain must be individually ‘qualified’. The scope and extent of the necessary qualification steps should be determined using a documented risk-assessment approach. So a product such as Tyvek® ACC needs to be qualified to show:

  1. that it consistently meets its quality and design performance specification – thermal properties, breathability, strength, etc. (Operational Qualification); and
  2. that it meets its performance specification under controlled conditions to demonstrate its performance behaviour in the volatility of changeable, real life situations (Performance
    Qualification).

These component qualification exercises are normally carried out by the product manufacturer i.e. DuPont in the case of Tyvek® air cargo covers. This qualification exercise will normally include an overall analysis of all the relevant elements and procedures of the distribution chain – route, handling, aircraft, airport facilities etc. followed by static ‘worst case’ tests and, lastly, by an empirical ‘in-situ’ service analysis where the outcomes are benchmarked against the static results. This product qualification then forms part of the overall validation of a shipping route or other coolchain solution. These route validation exercises are normally carried out by the pharma company and/or its 3PL partners.

Click here to view Week 4 – Tyvek® Air Cargo Covers – Part of an Overall Transport Validation Plan

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