Typical Qualification Lifecycle
20 years of CQV success
Pharmaceutical, Biotechnology, and Life Sciences industries necessitate high-standard Commissioning, Qualification, and Validation (CQV) as prescribed by industry guidance and regulations. CQV produces documented evidence, ensuring consistent and quality results. APF Projects offers an integrated project approach based on the ISPE Baseline Guide Volume 5: Commissioning and Qualification, 2nd Edition, which includes ASTM E2500 and ICH Q9 principles. This approach saves cost and time while meeting regulatory expectations.
To address evolving regulatory requirements and the need for efficient CQV activities, APF Projects focuses on optimised planning and deploying skilled CQV resources. They provide services such as audit preparation, cost and timeline estimates, ongoing CQV support, and assistance with audit remediation, deviations, CAPAs, and FMEAs.
Our expertise in C&Q delivery stems from time served experience with the following pharmaceutical and quality engineering manufacturing aspects:
APF Projects can assist Pharmaceutical manufacturers & Healthcare Service Providers increase effectiveness by ensuring Good Engineering Practices are being implemented.
This in turn increases the degree of quality assurance evident in manufacturing systems. Our validation life cycle services will at all times be made specific to your corporate, system and equipment needs, but essentially will facilitate planning and execution pertaining to: