CQV for a new production unit of gene and cell therapy treatments
CQV for a new production unit of gene and cell therapy treatments
project
Commissioning / verification and ASTM E2500 for a new Bio-Pilot plant
Compliance / Security Life Sciences Belgium
Context and challenges
This client is a Belgian biopharmaceutical company whose main activities consist of performing research, development and commercial launch of pharmaceutical and biotechnology products.
The construction of a Bio-Pilot plant on the Braine-L’Alleud site was initiated with the aim of meeting the company’s strategic and quantitative challenges.
Since 2014, this new building has been used for the production of products intended for phase I and II of clinical trials.
In this context, this client assigned Assystem Care the task of commissioning the plant and particularly verifying all of the GMP (Good Manufacturing Practices) systems following the ASTM E2500 approach.
Project scope
Management and coordination of plant start-up and testing of all production facilities assigned to clinical trials in compliance with GMP on upstream and downstream processes, using the ASTM E2500 verification guidance:
- Set-up of a systematic process, including completion of all tests required to meet users’ needs (attributes: CQA - Critical Quality Attributes & CPP - Critical Process Parameters), with respect to product quality and patient safety
- Evaluation of compliance of all GMP systems with respect to the work carried out by the design office until the end of phase 1 (EPCMV - Engineering, Procurement, Construction Management and Validation)
- Training of project team on best practices and quality standards
- Building of a two-year project plan aimed at preparing the building for routine production and the first GMP runs
- Support for preparation of administrative production approval documents
Client benefits
- Production approval obtained from Belgian authorities following first submission of necessary paperwork
- Start-up of facilities on schedule
- Compliance with production forecasts from the first batch (no non-conforming batches) through the integration of appropriate quality standards and client team skills increase
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