Qualification_Services Datasheet

bpeBPE’s engineers have a wealth of practical experience, supplemented by regular training, in the latest developments maintaining expertise and leadership inthe ? eld. As active members of the pharmaceutical community, we review draft guidelines and contribute to the knowledge-base to understand the bene? ts of implementing risk based validation approaches and Quality by Design (QbD). A Summary of our ServicesBPE offers a comprehensive, effective and fl exible Equipment and Systems Qualifi cation service to the Pharmaceutical Industries. Our engineers are fully conversant with the requirements of regulatory codes and guidelines 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 ISPE Baseline Guide on Commissioning and Qualifi cation. We also have substantial experience of working within the quality procedures of a number of blue-chip pharmaceutical companies.We facilitate all qualifi cation 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 Qualifi cation Rationales to identify what should be checked, why, how and by whomPROJECT MANAGEMENTCONTROL & INSTRUMENTATIONPROCESS SAFETYBIOTECHNOLOGYQUALIFICATION SERVICESPROCESS ENGINEERINGbpeF22136_QS.indd 1 21/3/12 17:54:30bpeExperience BaseBPE engineers have worked with numerous clientsaccommodating our standard methods to blend with localpractices.Where requested, our cross-company experience enables us to modernise local practices realising immediateefficiencies.BPE maintains its skill base through the membership ofprofessional bodies and participation in information exchange of latest practices.By application of a Risk Based Approach to Qualification, effort is focused appropriately, preventing unnecessary activities.Client BenefitsBPE engineers understand thesystems that they are working with ensuring a comprehensiveapproach enabling Acceptance Criteria to be readily identified.Extensive hands on experienceenables relevant documentation to be prepared and efficiently executed.A wealth of in-house knowledge enables complex systems to be evaluated against historical dataproviding immediate results.Documents can be created using the client’s own templates, or templates designed by BPE.DetailsBPE 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.>URSThe User Requirement Specification document is written with input from the key stakeholders. BPE engineers’ exceptional experience and understanding of both qualification and facility design / operation enables the user requirements to be easily established and documented.>VMPThe Validation Master Plan is a high level document capturing the project validation strategy. Our professional engineers have extensive knowledge and experience. We are able to offer a consistent interpretation, yet flexible and innovative approach, to guide all commissioning and qualification processes.>Protocol Generation / ExecutionFor 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 TrainingWith 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.BPE6 Wessex Business ParkWessex WayColden CommonWinchesterHampshire SO21 1WPTel +44(0)1962 717 070www.bpe-ds.comsales@bpe-ds.comQuality Management to ISO 9001:2008bpeFor further information please contact Mike Brown or visit us at: www.bpe-ds.comF22136_QS.indd 2 21/3/12 17:54:30