Continued Process Verification Research Assignment

Continued Process Verification
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Continued Process Verification
Effective process validation focuses on ensuring products meet the quality specifications. Henceforth, for drug manufacturing companies like in our case, process validation will contribute significantly in certifying that the drugs meet the quality desired. In one way or the other, one can argue that process validation enhances the core principle of quality assurance which is drugs produced should be fit for their intended use. Process validation includes a range of activities taking place all through the lifecycle of the product, from the raw material to finished product. It is classified into three stages, which are stage 1: process design, stage 2: process qualification and stage 3: continued process verification (FDA, 2011). Henceforth, the study moves focusing on literature, detailed review of regulations and guidelines relating to continued process verification. It also outlines the process validation approach to be adopted by the company for existing and new products to be formed. The aim of the study is to exemplify implementation of the third stage of process validation as offered in the 2011 FDA’s process validation guidance.
Literature Review
In 1963, the FDA presented the first 'current good manufacturing practice (CGMP) specifications' for medicinal drugs (FDA, 2011). This stirred up events leading to the present regulations for pharmaceuticals. The concept of process validation was introduced by two FDA officials, Loftus and Byers. Byers hosted the ‘design for quality approach while Loftus championed the ‘validation and stability’ approach. However, after the introduction of these process validation approaches it took the FDA approximately fifteen years to publish its first guide on general principles of process validation. The guide is intended to offer pharmaceutical industries the practices and principles of process validation (FDA, 2011). At that point, nobody knew that the guideline would become a chief source of process validation. Later the international conference on harmony developed the product lifecycle approach. This was part of the development of the FDA guidelines. The product lifecycle approach transformed the process validation paradigm. The August 2002, CGMPs for pharmaceutical industries stimulated the desire to develop and improve the pharmaceutical regulations for manufacturing and product quality (EMA, 2012). Due to this motif, the FDA collaborated with the International Conference on Harmony to enhance chances of developing a better guide.
Through the teamwork eventually, they came up with ICH10, pharmaceutical quality system which outlined the relationship between commercial manufacturing of pharmaceuticals, product development, product discontinuation and technology transfer. It also defined the need to fashion a guide for quality control of the product, especially in the course of commercial manufacturing phase. Consequently, there is a strong connection between ICH10 and the FDA 2011 guidance for pharmaceutical industries, stage 3: continued process verification, the latest FDA’s process validation approach (FDA, 2011).
FDA 2011 Guidance for Pharmaceutical Industries, Stage 3: Continued Process Verification
Continued Process Verification is defined as the process of ensuring that in the course of production or all through the lifecycle of a product the processes involved remain in a state of control (FDA, 2011). The term state of control denotes circumstances under which the set of specifications provides constant assurance that the product quality and process performance remains within acceptable limits (EMA, 2012). The FDA 2011 guide exemplifies continued process verification can be realized for an actual manufacturing process via the collection and evaluation of performance data for a given process by documenting continued process verification program (FDA, 2011). The continued process verification program for process evaluation is designed in such a way that it can detect undesired process variability, identity hitches and determine corrective and preventive action needed for solving or alleviating the problems.
The continued process verification program for process evaluation is directly aligned with the FDA’s good manufacturing practice (GMP) specifications in Code of Federal Regulations Title 211.110. The regulations call for the establishment of control procedures which facilitate the validation of the performance of the traditional manufacturing processes that might be the chief cause of variability in the lifecycle of a product which includes in-process materials and final product (FDA, 2011). This predicate guidance provides the base for observation and ...