AM Life Sciences (AMLS) has completed and turned over work for upgrades to a New England pharmaceutical company’s Engineering and Commissioning, Qualification, and Validation (CQV) Lifecycle program for equipment and systems.
AMLS led the effort by focusing on the principles identified in ASTM 2500 (version 13) Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
The effort was executed in a phased approach. All phases were integrated with corporate level standards and specifications, as applicable.
How AMLS Completed Each Phase of the Engineering & CQV Lifecycle Program
AMLS completed three phases of work to ensure complete implementation and support.
– Phase 1 included the revision or generation of site plans, standards, and SOPs with regards to design of the equipment/systems. This ensured the design was based in risk, science, and process knowledge.
– Phase 2 included the revision or generation of site plans, standards, and SOPs with regards to protocol writing and execution.
– Phase 3 included the development of pre-approved attachments for routine tests, limiting the time spent on protocol generation activities.
Throughout the process, AMLS provided training and hands-on activities for key personnel at the pharmaceutical company. Our focus was to help personnel understand the “why” behind the new procedures. The result of our education assistance and training was universal support of the new methods in the CQV program.
– Consider working with AMLS to support upgrades to your engineering and CQV lifecycle program. Contact us today to schedule a consultation.
