Industry guidance

Sponsor modifies own legally marketed class II device and with Standards FDA/industry guidance... 

Standard on Explosion Prevention Systems, National Fire Protection Association, 2002). For example, methyl acrylate and ethyl acrylate are commonly stabilized with hydroquinone monomethyl ether. Industry guidance recommends a minimum concentration of 5 vol % 02 in the atmosphere above the acrylate to prevent polymerization (Intercompany Committee for the Safety and Handling of Acrylic Monomers, Acrylate Esters, A Summary of Safety ana Handling, 3d ed., 2002). 

In 1985, AIChE established the Center for Chemical Process Safety (CCPS) in response to the Bhopal tragedy. Manufacturers, government, and scientific research groups sponsor CCPS, which has published extensive industry guidance in the area of process safety technology and management. CCPS recently produced a safety alert on reactive hazards, and a more comprehensive product is under development. 

This CCPS publication, Essential Practices for Managing Chemical Reactivity Hazards, may address this gap in industry guidance. 

Suggested improvements to industry guidance or initiatives (e.g., Responsible Care [ACC], Responsible Distribution Process [RDP NACD]) to reduce the number and severity of reactive chemical incidents. 

Specify requirements and include them in your user requirement specifications document. Information on the requirements can be obtained from the regulation itself and from Part 11 industry guidance documents. 

Industry groups and regulatory authorities have debated and addressed the issues surrounding computer system validation, with the PDA [4] and GAMP Forum [3] providing industry guidance on validation life-cycle methodology and documentation. 

Guidance for Industry Guidance for Human Somatic Cell Therapy and Gene Therapy (1998)... 

Viral vector and cell-based vaccines FDA guidance for industry guidance for human somatic cell therapy and gene therapy 1998... 

US FDA (1996) Guidance for Industry Guidance for the clinical evaluation of weight control drugs. September 1996 US FDA (2002) Guidance for Industry Food effect bioavailabil-ity and bioequivalence studies. December 2002... 

The FDA contributed to the guide and focused on the practicalities of validation. It set the tone for future industry guidance, demonstrating the benefit of collaboration between regulatory authorities and industry. 

Individual procedures can easily consume 10 to 15 days effort to produce, even with experienced staff. Use should be made of industry guidance when developing procedures, e.g., GAMP example procedures and IEEE standards. Where existing procedures are being revised to secure validation compliance, this estimate of effort could be reduced by about half. As recommended above, this should be supplemented with about 20 days effort across all the procedures, shared among a team of end users. The individuals should contain the core users who are involved in all the procedures in order to ensure consistency. Other end users on the team, however, can be seconded for the development of particular procedures in which they have a specific interest, or can contribute a particular skill or competence. For instance, an end user quality representative may wish to be seconded for the development of the Supplier Audit procedure. 

FDA (1998), Guidance for FDA Reviewers and Industry Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices, May 29. 

Dechlorination is an evolving practice in the water industry. Currently, there is no industry guidance or American Water Works Association (AWWA) standard for disposal of chlorinated water (5-7). The AWWA standard for disinfection of water mains (C651-92) provides some information on disposal of chlorinated waters. This information, presented as an appendix, is not a part of the standard. Regulations and permit programs for disposal of chlorinated waters vary widely among the states and provinces. 

FDA published the Black Book containing industry guidance entitled Procedures for Appraisal of the Toxicity of Chemicals in Food. 1951 Durham-Humphrey Amendment defined the types of drugs that could only be used with medical supervision and restricted their sale by prescription of a licensed physician. 

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