Product Quality Review Vs. Continued Process Verification (PQR Vs.CPV). A Practical Guide for Pharmaceutical Industries in adhering with Regulatory Compliance requirements

      Аннотация: Product Quality Review and Continued Process Verification are the key essential documents through which a regulatory inspection normally begins in pharmaceutical industry, while evaluating the consistency and robustness of a product or processes is not merely a regulatory requirement but important for a firm is to learn and introspect their product and process performance and whether manufacturing process including systems and sub-operations do functions in collaboration with each other to deliver sustainable quality products in servicing to mankind across the consumer(s) value chain. PQR & CPV are the documentational outcome not limited to manufacturing processes but mainly are the results of a robust QMS possess encompasses the organization structure, systems, processes, procedures, resources, operations, supply chain, Quality control, Quality Assurance function together to provide safe and quality medicines to deserving patients. With the crisp book on PQR/CPV, author put an effort to deliver a standardized framework in documenting PQR Vs. CPV program can benefit to pharmaceutical industries at large as well can add value to academia, pharmaceutical professionals.

Ключевые слова: Continued Process verification, Annual Product Review, Product Quality Review, Process Capability, statistical evaluation, Process Excellence, Lean Six Sigma, GMP Compliance, Pharmaceutical Operations and Compliance, Regulatory Compliance, USFDA, MHRA, EU, EMA, WHO, ICH, PICS, Regulatory audits and compliance, Pharmaceutical regulated industry