Timur Güvercinci, Merck Healthcare KGaA, Darmstadt and self-employed GMP Trainer and Consultant
With the change of FDA´s process validation guideline from 1987 and the Annex 15 of EU GMP Guide, a validation life cycle entered the validation world. The development, the validation of the manufacturing process/ Process Performance Qualification (PPQ) and the Ongoing/Continued Process Verification are now the current validation stages. Especially the requirement for a stage 3 is a challenge for enterprises as this stage is new and did not exist before the validation life cycle. The Ongoing/Continued Process Verification will substitute revalidation in most cases. It supplements the Product Quality Review (PQR) or Annual Product Review (APR), which is usually written in the USA every year. The FDA Process Validation Guidance requires statistically sounded data evaluated from a statistically trained person. Both in Europa and in the USA, this stage 3 is intended to show that the process is in “control of state”. This applies to the single batches (intra-batch-variabilities) and to the comparison of single batches with each other (inter-batch-variabilities).This gives rise to a number of questions. Which data of a manufacturing process should be evaluated in an Ongoing/Continued Process Verification according to a rationale? How is the statistical sampling in this context? What statistical indicators are required? How can the requirements be implemented in small and medium-sized companies in a pragmatic way?
Employees from companies, who are involved in pharmaceutical process validation activities (developers, QM, manufacturing, heads of validation departments, etc.) especially regarding stage 3 ongoing/continued process verification, are addressed. Of course consultants in this field, who want to get information from the view of the medicinal product manufacturers, are addressed too
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.