Guidance general principles

HMIP publish sets of Guidance Notes, which relate to activities they control. These notes are known as Best Practicable Means (BPM) Notes. BPM is explained in Note BPM 1/88, Best Practicable Means. General Principles and Practices. Copies of these notes may be obtained from the Department of the Environment Publications Sales Unit, Building 1, Victoria Road, South Ruislip, Middlesex HA4 ONZ, telephone 020 8841 3425. 

FDA Guidance Guideline on general principles of process validation. www.fda.gov. 

General Principles of Software Validation Final Guidance for Industry and FDA Staff, found at http //www.fda.gov/cdrh/comp/guidance/938.pdf. 

A CSR is a risk assessment, following the general provisions of Annex I of the proposed REACH Regulation, with extra guidance in Annex IB for substances that are components of preparations. These general principles correspond with the current EU practice for notified new substances and priority existing substances, as described more fully in Section 14. The ECA will develop software to help registrants prepare the CSR. It is essential to have input from downstream users to prepare the risk assessment for the CSR, which... 

US FDA Guidance for Industry Process validation General Principles and Practice, Draft guidance, November... 

General principles of process validation http //www.fda.gov/cder/guidance/ pv.htm... 

Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Guidehne on general principles of process validation, available http //www.fda.gov/cder/ guidance/pv.htm, accessed Apr. 26,2006. 

For more details, the works listed in the Bibliography should be consulted. In particular, Crosby and Patel s General Principles of Good Sampling Practice and Prichard provide readily digestible guidance to current best practices in this area. 

In the same way that the medical profession has recognized the need to provide its members with guidance on their relationship with the pharmaceutical industry, the pharmaceutical industry has realized that its employees need guidance as well. The industry is concerned that its employees may sully the pharmaceutical industry s reputation. The industry does not want their interactions with healthcare professionals to be perceived as inappropriate by patients or the public at large (PhRMA 2002). In order to avoid being overrun with the detailed nature of voluntary codes at the level of national associations, it is perhaps most instructive to start with the general principles contained in the IFPMA Code of Pharmaceutical Marketing Practices (IFPMA 2000). 

U.S. Food and Drug Administration. Guidance on General Principles of Process Validation. (1987). 

Analysis—Requirements for equipment qualification have been in existence for many years. The FDA outlined the basic requirements in the Guideline on General Principles of Validation [11], There is really no excuse for the firm to have omitted this for a new piece of equipment. Note that FDA used the term equipment qualification, suggesting a combined approach would be acceptable. The FDA guidance mentioned above speaks only to equipment qualification, not IQ or OQ. 

The ICH guidance on immunotoxicity testing suggests a weight-of-evidence decision making approach. The general principles that apply to this guideline are as follows ... 

FDA (2002), General Principles for Software Validation (Medical Devices), Final Guidance for Industry, January. 

EDA (1997), General Principles of Software Validation Guidance for Industry, Draft Guidance Version 1.1., June. 

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