8th of January 2021
Integrated Qualification and Validation Guide
8th of January 2021
The validation working group of ECA published a good practice guide for integrated qualification and validation based on customer and supplier partnership. The guide has been jointly prepared by plant manufacturers, pharmaceutical companies and consultants. Also the opinions of inspectors were included. Employees of Valicare were involved in the creation of the document and were able to contribute actively their knowledge and experience.
On the one hand, the aim of the manual is to achieve a better understanding of the project, the process and the technical solution. On the other hand, the “single test approach” is intended to optimize the time and costs involved in reaching the qualified state of the equipment.
The manual explains important terms and describes a possible cooperation and task distribution between the manufacturer of the pharmaceutical plant and the customer. All important topics are addressed, starting with user requirement specifications (URS), risk management (RM), a common project quality plan (PQP), project management, design review up to qualification/validation. Central elements of the concept are the critical aspects risk assessment (CARA), a concerted change management, the requirment traceability matrix (RTM) and the test matrix (TM).
Valicare GmbH (subsidiary of Syntegon Technology GmbH) has extensive experience in all stages of validation projects, starting with the validation master plan, the required work instructions and the practical implementation. We are guided by regulatory requirements and the state of the art. We are also happy to implement the working method described in the guide for your systems.
We would also be happy to advise you in advance by telephone.
Find out about our GMP-compliant qualification & validation services.
Author: Dr. Carsten Boerger, Senior GMP Consultant, Valicare