Regulatory agencies guidelines

Many pharmaceutical companies outsource one or more of the control, manufacturing, and chemistry (CMC) processes, for which numerous regulatory agencies guidelines are available. Reasons for this outsourcing include but are not limited to ... 

Guidelines and directive requirements are worded generally, without sufficient detail to allow an interpretation of what is actually wanted by the regulatory agencies in a particular case. How can the interested manufacturer determine what the current practical requirements of the regulatory agencies are ... 

In this book I will share with you the process by which I came to this conclusion and the scientific evidence on which it is based. This includes evidence that was known to the pharmaceutical companies and to regulatory agencies, but that was intentionally withheld from prescribing physicians, their patients and even from the National Institute for Health and Clinical Excellence (NICE) when it was drawing up treatment guidelines for the National Health Service (NHS) in the UK. 

Criteria have not yet been formulated by regulatory agencies for protection of sensitive fish and wildlife resources against fenvalerate. Guidelines for protection of poultry, livestock, and human health include <50 mg/kg in poultry diets, <5 mg/kg in livestock diets, <3 mg/kg in human diets, and <0.125 mg/kg BW daily in humans. 

Regulatory agencies in various geographical regions enforce guidelines to ensure the quality and uniformity of pharmaceutical substances. 

The minimum standards for the facilities in which clinical pharmacology studies should be conducted are described in ABPl guidelines. Clearly, the same standards should apply to all organisations involved in conducting studies. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) has instituted inspection of facilities and procedures, and a system of certification is in place. 

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