BPE offers a comprehensive, effective and flexible Equipment and Systems Qualification service
to the Pharmaceutical Industry. Our engineers are fully conversant with the requirements of regulatory codes and guides such as the American (CFR 21 parts 210-211), British (MCA Orange Guide), European (EU GMP Guide Annex 15) and ISPE Baseline Guides. We also have substantial experience of working within the quality procedures of a number of blue chip pharmaceutical companies.

Expertise Includes:

• System Impact Assessment
• Enhanced documentation, document management and approval process
• Change control
• End User Participation
• Training
• Use of Qualification Rationales to identify what should be checked,
  why, how and by whom

Services Offered:
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

URS
The User Requirement Specification document is written with input from the end user. BPE engineers’ unique experience and understanding of both qualification and facility design / operation enables the user requirements to be easily established and documented.

VMP
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 (DQ), IQ, OQ and PQ to ensure compliance with CGMP

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.

Download Qualification Services PDF Sheet