Commissioning and Qualification Services
BPE offers comprehensive, effective and flexible Equipment and Systems Commissioning and Qualification services to their Pharmaceutical and Biopharmaceutical customers. Our engineers are fully conversant with the requirements of regulatory codes and guides such as the American (FDA CFR 21 parts 210-211), British (MHRA Orange Guide), European (EU GMP Guide Annex 15), Internationally Harmonised (ICH GMP Q7 and ICH QRM 09) and the ISPE Baseline Guide on Commissioning and Qualification. We also have substantial experience of working within the quality procedures of a number of blue chip Pharmaceutical and Biotech’ companies.
Our philosophy is for our process and project engineers who have worked throughout the project to undertake the commissioning and qualification. They will have developed user requirement specifications with the operational and quality personnel and taken these through design, acceptance testing and construction so that they will be intimately familiar with the equipment and the user and quality teams expectations when they commission and qualify. Where specialist regulatory advice is needed BPE will refer to industry leaders through their partners GXPi.
We facilitate all qualification practices, including:
- System Impact Assessment
- Enhanced documentation, document management and Approval Processes
- Change control
- End User Participation
- CSV and GAMP including CFR 21 Part II
- Use of Qualification Rationales to identify what should be checked, why, how and by whom
BPE has core competencies of project management, engineering design and knowledge of statutory and industry safety, health and environmental requirements. These skills are applied throughout the project lifecycle ensuring added value is delivered to all of our qualification activities.
The User Requirement Specification document is written with input from the end user. BPE engineers’ exceptional experience and understanding of both qualification and facility design / operation enables the user requirements to be easily established and documented.
The Validation Master Plan is a high level document capturing the project validation strategy. Our professional engineers have extensive knowledge and experience meaning that we are able to offer a consistent interpretation, yet flexible and innovative approach, to guide all commissioning and qualification processes.
Protocol Generation / Execution:
For direct impact systems BPE have a track record of delivering a comprehensive and cost effective service including Enhanced Design Review (EDR), DQ/ IQ/ OQ /PQ to ensure compliance with cGMP and GEP.
SOPs, Commissioning and Training:
With our continued success in integrating commissioning activities to support the qualification exercise we are also able to generate or update existing Standard Operating Procedures to ensure safe and compliant handover of new facilities.