Process Validation and Drug Quality Approach to Process Validation.
US FDA in its guidelines issued in Jan 2011 about process validation with respect to current Good Manufacturing Practices (CGMP) stated that “FDA is responsible and have the authority to evaluate, inspect the process validation carried out by a pharmaceutical manufacturer. The CGMP regulations current Good Manufacturing Practices for validating drug, pharmaceuticals manufacturing require that pharmaceuticals or drug products must be manufactured with a assurance of a very high degree for complying all the standards and attributes with which the drug products are required to comply (21 CFR 211.100(a) and 211.110(a)).”
Process validation and its regulatory, statutory requirements.
Also see ( process validation in pharma )
In year 1987 US FDA issued first guidelines about general Principles of Process Validation and it is revised on Jan 2011, This revised guidance on Current Good Manufacturing Practices (CGMP) and Process Validation General Principles and Practices provides current FDA’s current thoughts about process validation and it is more or less have the basic principles first introduced in the 1987 guidelines.
The revised guidance on Current Good Manufacturing Practices (CGMP) and Process Validation guidance enlists some of the recommendations to achieve the goals of US FDA’s initiative entitled “Pharmaceutical current Good Manufacturing Practices (CGMPs) for 21st Century , The Risk-Based Approach,” particularly with respect to the use of technological advances in pharmaceutical manufacturing, as well as implementation of modern risk management and quality system tools and concepts.
A. Process Validation and Drug Quality
Effective process validation contributes significantly to assuring drug quality. The basic principle of quality assurance is that a drug should be produced that is fit for its intended use. This principle incorporates the understanding that the following conditions exist:
1.Quality, safety, and efficacy are designed or built into the product.
2.Quality cannot be adequately assured merely by in-process and finished-product inspection or testing.
3.Each step of a manufacturing process is controlled to assure that the finished product meets all quality attributes including specifications.
B. Approach to Process Validation
For purposes of this guidance, process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. It describes process validation activities in three stages.
Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
The Jan 2011 guidelines on process validation describes activities typical of each stage, but in practice, some activities might occur in multiple stages.
Before any batch from the process is commercially distributed for use by consumers, a manufacturer should have gained a high degree of assurance in the performance of the manufacturing process such that it will consistently produce APIs and drug products meeting those attributes relating to identity, strength, quality, purity, and potency. The assurance should be obtained from objective information and data from laboratory-, pilot-, and/or commercial-scale studies. Information and data should demonstrate that the commercial manufacturing process is capable of consistently producing acceptable quality products within commercial manufacturing conditions.
A successful validation program depends upon information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of the manufacturing process that results in products with the desired quality attributes. Manufacturers should:
*Understand the sources of variation
*Detect the presence and degree of variation
*Understand the impact of variation on the process and ultimately on product attributes
*Control the variation in a manner commensurate with the risk it represents to the process and product
Each manufacturer should judge whether it has gained sufficient understanding to provide a high degree of assurance in its manufacturing process to justify commercial distribution of the drug product. Focusing exclusively on qualification efforts without also understanding the manufacturing process and associated variations may not lead to adequate assurance of quality. After establishing and confirming the process, manufacturers must maintain the process in a state of control over the life of the process, even as materials, equipment, production environment, personnel, and manufacturing procedures change.
Manufacturers should use ongoing programs to collect and analyze product and process data to evaluate the state of control of the process. These programs may identify process or product problems or opportunities for process improvements that can be evaluated and implemented through some of the activities described in Stages 1 and 2.
Manufacturers of legacy products can take advantage of the knowledge gained from the original process development and qualification work as well as manufacturing experience to continually improve their processes. Implementation of the recommendations in the guidance issued in Jan 2011 is for legacy products and processes would likely begin with the activities described in Stage 3. Also see ( process validation in pharma )
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We are going to publish the series of articles on process validation in pharmaceutical manufacturing, with respect to c GMP guidelines.