Quality Metrics Supports New Validation Approach
They do also not replace other quality management elements such as senior management’s commitment to quality and the quality culture of the company. The Quality Metrics support nicely the efforts that are part of the new process validation approach and the new quality management thinking in e.g. the European GMP regulation.
Since October 2015, when the new EU GMP Annex 15 for Qualification and Validation became valid, three validation runs are no longer enough (if they ever were). Some companies have practiced process validation as “three batches — and done!” but the new Annex 15 (and other parts of the updated EU GMP regulation) is expecting ongoing process verification by which you regularly evaluate the performance of pharmaceutical manufacturing and quality management processes.
Win Win Situation for all Involved
The relation to the new process validation requirements is clear in the draft guidance. It builds on the same concept as FDA’s process validation guidance (and the PAT guidance) that manufacturers should understand the sources of variation, detect the presence and degree of variation, understand the impact of variation on the process and ultimately on product attributes and (most importantly) control the variation in a manner commensurate with its risk to the process and product.
Also the link to the ongoing (or continued) process verification is clearly stated with the expectation that after the initial process validation, manufacturers must maintain a state of control during the life cycle of the process, including the management of changes in materials, equipment, personnel, procedures etc.
Summarized, we should keep in mind that FDA’s new Quality Metrics concept is potentially a win-win for companies that have a good and effective quality management system. It has often been demonstrated that there is a relation between the quality performance of a company and its business performance. So, it is a good idea to be careful in the implementation of a Quality Metrics system because it can be done in a way that supports better business performance. The message is clear although the guidance is not finished yet: whether Quality Metrics are a challenge or an opportunity depends on how you implement it. It is up to you …
* Gert Moelgaard was Corporate Vice President Strategic Development at NNE Pharmaplan until January 2016 and is now supporting the company as Senior Consultant. NNE Pharmaplan is an international company specialised in pharma engineering.