Guidance guidelines

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

CBER Guidances/Guidelines/Points to Consider, http //www.fda.gov/cber/ guidelines.htm... 

ICH Harmonized Tripartite Guidance. Guideline for good clinical practice, E6, May 1, 1996. 

EMEA (2005) Guidance guideline on plastic immediate packaging materials, CPMP/QWP/4359/03. 

The Center for Chemical Process Safety (CCPS) of the American Institution of Chemical Engineers (AlChE) guidance Guidelines for risk based process safety identifies good practice on process safety management. It is structured as follows ... 

Substance listing EU Commission, Directorate General for Health and Consumers, food contact materials database (European Commission 2013) Guidance Guideline of the EFSA CEF scientific panel (EFSA 2008)... 

In 1995, discussions among the United States, the European Community (EC), and Japan occurred to achieve harmonization of dmg and dmg product standards and to provide guidance to the worldwide pharmaceutical industry for acceptance of global regulatory filings. The International Committee on Harmonization (ICH) has proposed initial guidelines for the estabUshment of stabihty studies. 

A number of codes, standards, guidelines, and recommended practices promulgated by organizations such as NFPA and API are provided in the reference section. Additional guidance applicable to warehousing includes... 

An assessment package is a tool within a system. It can provide assessment forms, guidance notes and scoring guidelines to conduct an evaluation of a toller s quality/safety system. This sample uses assessment forms to evaluate fourteen components. The results are then compiled in the evaluation summary. The evaluation summary is the basis for a report back to the toller and for mutual discussion... 

A properly written HASP should contain worker health and safety program information, guidance, and alternatives. The HASP should quickly answer the following questions What hazards are present and How can we make sure that the tasks will be performed safely The following general guidelines will help to answer these questions ... 

In the bibliography to ISO/TS 16949 there is only one customer reference manual mentioned the QS-9000 Measurement Systems Analysis Manual. This provides excellent guidelines for selecting procedures to assess the quality of a measurement system. It includes an introduction to measurement systems, explains the factors that cause variation in a measurement system, has guidance for preparing for a measurement system study, and includes step-by-step procedures for determining the degree of each type of variation present in a measurement system. 

The CCPS book Guidelines for Auditing Process Safety Management Systems provides guidance on developing PSM audit programs and conducting... 

Read Chapter 2 of the CCPS publication Guidelines for Implementing Process Safety Management Systems, 1993, for guidance on obtaining buy-in. The principles described for obtaining support and commitment for PSM are equally applicable to integration of PSM and ESH. 

The American Institute of Chemical Engineers (AIChE) wishes to thank the Center for Chemical Process Safety (CCPS) and those involved in its operation, including its many sponsors whose funding made this project possible the members of its Technical Steering Committee who conceived of and supported this Guidelines project and the members of its Equipment Reliability Data Subcommittee for their dedicated efforts, technical contributions, and the guidance necessary for the preparation of this work. 

The Japanese regulatory authority is the Ministry of Health and Welfare (MHW) and the Pharmaceutical and Medical Safety Bureau (PSMB) is responsible for the promulgation of national and international guidelines in the form of Notifications. Guidelines are available on the Internet web-site of the National Institute of Health and Science (http //www.nihs.go.jp). The MHW has not issued specific guidance on the development of chiral drugs, but has nonetheless responded to the enantiomer-versus-racemate scientific debate. The attitude of the MHW and its advisory body, the Central Pharmaceutical Affairs Council (CPAC) is discussed in two articles by Shindo and Caldwell published in 1991 and 1995 [17, 18]. The latter paper analyzes the results of a survey of the Japanese pharmaceutical industry which sought responses on chirality issues. 

Guidance on specifications is divided into universal tests/criteria which are considered generally applicable to all new substances/products and specific tests/criteria which may need to be addressed on a case-by-case basis when they have an impact on the quality for batch control. Tests are expected to follow the ICH guideline on analytical validation (Section 13.5.4). Identification of the drug substance is included in the universal category, and such a test must be able discriminate between compounds of closely related structure which are likely to be present. It is acknowledged here that optically active substances may need specific identification testing or performance of a chiral assay in addition to this requirement. 

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