Pablo Quiles

The FDA process validation guidance, Guidance for Industry: Process Validation- General Principles and Practices, outlines and separates process validation activities in three stages;  Stage 1: Process Design (where Critical Process Parameters or CPPs and Critical Quality Attributed or CQAs are determined), Stage 2: Process Qualification,  and Stage 3: Continued Process Verification (CPV).  The first two…

Risk management consist of the application of policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, mitigating and monitoring risks as described by ISO 14971, ISO 13485, FDA’s 21st century GMP and ICH initiatives (such as Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System).  Especially after the aforementioned guidelines…