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Thursday, March 24, 2011

Process validation and its regulatory, statutory requirements.

Process validation good manufacturing good manufacturing practices guidelines

A drug can be termed or deemed to be adulterated even though the drug manufactured by a pharmaceutical manufacturer meets all standards of its purity and efficacy and if the process, methods, facilities, controls, adapted to manufacture the drug or packing processing or holding drug product do not comply with or do not follow good manufacturing practice or the methods used in or the controls and facilities used for its.

In summary, the GMP guidelines or cgmp regulations require that manufacturing processes be designed and controlled to assure that in-process materials and the finished product meet predetermined quality requirements and do so consistently and reliably.
Good manufacturing practices are required to follow to assure that the drug product being manufactured meets to the required standards of purity and safety and quality consistently.
Also see ( process validation in pharma )
Above requirement calls for the process undertaken to be satisfactorily validated, never the less the process validation for drug product manufacturing or for its components or finished pharmaceuticals stands legally enforceable section 501(a)(2)(B) of the Act (21 U.S.C. 351(a)(2)(B)), say the guidelines published by US FDA on process validation with respect to Current Good Manufacturing Practices (CGMP) published by US FDA on Jan 2011.

US FDA has provided its regulations on current good manufacturing practices (CGMP) in CFR 21 Part 210 and CFR 21 Part 211. These c gmp guidelines calls for process adapted to manufacture should be controlled even on in process material and final product as well to achieve preset quality standards and the in process material and the finished product meet the standards consistently in any given process or set of process.

Therefore it is very important to validate the process adapted to manufacture the drug products as it is also a statutory requirement of US FDA gmp regulation 21 cfr Part 210 and 21 cfr part 211.These gmp guidelines says that there must be a written procedure available for process control and production of pharmaceutical or drug, the written procedure made should be designed in the manner to assure that the drug product manufactured meet the predetermined quality and standards with respect to purity strength and identity , quality or the represented process (How important is Process validation). Therefore the regulation it self calls for pharmaceutical manufacturers to establish in process controls and then the process validation.

Other CGMP regulations define the various aspects of validation. For example, § 211.110(a), Sampling and testing of in-process materials and drug products, requires that control procedures “. . . be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product” (emphasis added). Under this regulation, even well-designed processes must include in-process control procedures to assure final product quality. In addition, the CGMP regulations regarding sampling set forth a number of requirements for validation: samples must represent the batch under analysis (§ 211.160(b)(3)); the sampling plan must result in statistical confidence (§ 211.165(c) and (d)); and the batch must meet its predetermined specifications (§ 211.165(a)).
In addition to sampling requirements, the CGMP regulations also provide norms for establishing in-process specifications as an aspect of process validation. Section 211.110(b) establishes two principles to follow when establishing in-process specifications. The first principle is that “. . . in-process specifications for such characteristics [of in-process material and the drug product] shall be consistent with drug product final specifications . . . .” Accordingly, in-process material should be controlled to assure that the final drug product will meet its quality requirements. The second principle in this regulation further requires that in-process specifications “. . . shall be derived from previous acceptable process average and process variability estimates where possible and determined by the application of suitable statistical procedures where appropriate.” This requirement, in part, establishes the need for manufacturers to analyze process performance and control batch-to-batch variability.
The C GMP guidelines also describe and define activities connected with process design, development, and maintenance. Section 211.180(e) requires that information and data about product quality and manufacturing experience be periodically reviewed to determine whether any changes to the established process are warranted. Ongoing feedback about product quality and process performance is an essential feature of process maintenance.
In addition, the CGMP guidelines , regulations require that facilities in which drugs are manufactured be of suitable size, construction, and location to facilitate proper operations (§ 211.42). Equipment must be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use (§ 211.63). Automated, mechanical, and electronic equipment must be calibrated, inspected, or checked according to a written program designed to assure proper performance (§ 211.68).

We will be publishing the series of articles on current good manufacturing practices requirements of process validation, process validation guidelines.

Also see:
1.Quality assurance in pharma industry

2.Quality by designe concept for pharmaceutical industry

3.Quality by designe concept in pharmaceutical industryan explanation

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