Validation committees

If it has not been already completed, the first recommended task is to establish/designate a validation team within the company—perhaps one snch team at each of mnltiple sites. If one elects to have a separate team at mnltiple sites, these teams mnst make certain that they carry ont the validation processes consistently across all sites. In larger corporations, this is often accomplished via a central validation committee managing the individnal gronps at the varions sites. For smaller companies a team may consist of only one individual. The goal of the team(s)/committee is to draft comprehensive validation plans and protocols across all the instrnments, systems and processes that reqnire validation. They must then diligently execnte, document and verify each validation procedure. 

PMA s Computer Systems Validation Committee, Validation concepts for computer systems used in the manufacture of drug products, Pharm. TechnoL, 10(5), 24, 1986. 

Which organizational functions will be represented on the validation committee ... 

European Agency for the Evaluation of Medicinal Products. Note for Guidance on Process Validation. Committee for Proprietary Medicinal Products, CPMP/QWP/ 848/96, London (2001). 

Protocol Summary. A summary of the protocol documentation. including an analysis of the test results, the compliance audit of the system, and any system modifications should be submitted to the computer systems validation committee for their review and approval. It is recommended that the system not be used until final validation approval is received from the committee. 

PDA/PhRMA s Computer System Validation Committee—System Definition, Design,... 

Mike Wyrick, chairman of the PDA Computer Validation Committee, published the following top ten quality noncompliance observations recorded by U.S. Food and Drug Administration (FDA) inspectors. The data were collated from over 700 inspection citations issued between 1984 and 1999, and from conference presentations by European inspectors who highlighted similar issues. 

Responding to the FDA s proaetive position on computer systems validation, the U.S. PMA formed a Computer Systems Validation Committee to represent and coordinate the industry s viewpoint. 

The paradigm shifts in computer validation between 1986 and 1997 were chronicled in a key practice document published by PhRMA s Computer Systems Validation Committee.It noted... 

Establish a Company Validation Committee to set the company computer validation strategy, approve the validation policy, provide oversight, and agree on funding models. 

Grigonis, G.J. and Wyrick, M.L. (1994), Computer System Validation Auditing Computer Systems for Quality, Report on behalf of PhRMA Computer Systems Validation Committee, Pharmaceutical... 

CSVC Computer Systems Validation Committee (of PhRMA)... 

Even though the responsibility for batch acceptance or rejection lies with the head of the quality control unit, the help of the validation committee should prove useful in reviewing the process of OOS investigation and arriving at a recommendation for action taken. 

PMA Computer Systems Validation Committee. Computer systems validation—Staying current Introduction. Pharm. Technol. 13 60-65, 1980. 

A validation programme should be co-ordinated by a multidisciplinary committee comprised of the different functions that are involved in the programme. Typically, the members of the validation committee would be drawn from departments such as production, quality assurance, microbiological and analytical quality control, pharmaceutical development, engineering, and maintenance. The committee approves and issues written protocols, and reviews the data obtained in order to approve or reject the programme results. 

The VMP should be a concise and easy to read document which will serve as a guide to the validation committee, and personnel who are responsible for implementing validation protocols. The VMP should also be viewed as being a source document for use by regulatory auditors. 

Validation Concepts for Computer Systems Used in the USA GMP Manufacture of Drug Products USA GMP PMA s Computer System Validation Committee (Pharm. Technol. May 1986, pp. 24-34) PI (N) 1986... 

The best way to assure that all automated systems used for GxP activities are developed, validated, used and maintained in line with GxP regulations and that the support organization implements and follows a GxP-compliant QA system is to have a validation committee. This could be a separate committee dedicated to the validation of automated systems or combined with the central validation committee that often already exists, particularly at manufacturing sites. The major tasks and responsibilites that could be assigned to this committee are presented in Table 13.4. 

Table 13.4. Major Tasks and Responsibilities of the Validation Committee...

Setting up proper risk assessment procedures and applying them to the change control process markedly reduces the efforts required to keep systems in a validated state. Harmonization, standardization and efficiency can be increased by appointing a company computer validation committee per site and/or at a corporate level. Good cooperation between QA and IT is a prerequisite for keeping systems validated. 

Mr. de Jong is currently ITQA manager and is responsible for the quality system of the IT department of Solvay Pharmaceuticals in The Netherlands. He started his career in IT in 1978 as system specialist for Honeywell Bull, and joined Solvay in 1985 as a system analyst for the R D (research and development) automation center, especially within the Good Laboratory Practice (GLP) environment. He was involved in the translation of GxP guidelines to the IT world, in system development as well as system management. He is also member of Solvay s Computer Validation Committee. 

Ms. Koelman is currently global GLP/GCP (Good Clinical Practice) QA director within Solvay Pharmaceuticals. Previously, she was head of the GLP Quality Assurance Unit of Solvay Pharmaceuticals. She has been the leader of the project team that set up the local computer validation policy of Solvay Pharmaceuticals B.V. and also leader of the team responsible for implementing this policy in the company over a period of two years, before it was handed over to a permanent Computer Validation Committee. She has been involved in a number of validation projects of different types of systems, ranging from simple equipment to complex custom-built or highly customized applications. 

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