Inter Relationship Between Ra, QA, QC For Regulatory Submission

Abstract

This guidance is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211). Many of the modern quality system concepts described here correlate very closely with the CGMP regulations. Current industry practice generally divides the responsibilities of the quality control unit (QCU), as defined in the CGMP regulations, between quality control (QC) and quality assurance (QA) functions. QC usually involves (1) assessing the suitability of incoming components, containers, closures, labeling, in-process materials, and the finished products; (2) evaluating the performance of the manufacturing process to ensure adherence to proper specifications and limits; and (3) determining the acceptability of each batch for release. QA primarily involves (1) review and approval of all procedures related to production and maintenance, (2) review of associated records, and (3) auditing and performing/evaluating trend analyses. The concept of a quality unit is also consistent with modern quality systems in ensuring that the various operations associated with all systems are appropriately planned, approved, conducted, and monitored. Quality by design means designing and developing a product and associated manufacturing processes that will be used during product development to ensure that the product consistently attains a predefined quality at the end of the manufacturing process. Quality by design, in conjunction with a quality system, provides a sound framework for the transfer of product knowledge and process understanding from drug development to the commercial manufacturing processes and for post-development changes and optimization.