A guidance document is a publication, often by a regulatory agency, that contains a set of instructions, often to establish the publisher's expectations. They are often used to explain the objective or interpretation of a vague or nonspecific law or requirement.
Types of guidance documents
While guidance documents are not usually enforceable rules or requirements by themselves, they often define standards or expectations which are part of a rule or requirement. For example, a regulation might require adequate testing for relevant microorganisms in sterile containers and a guidance document would be used to explain what testing is adequate and which organisms are relevant.
Guidance documents are also used to explain internal policies or practices to simplify an organization's interactions with other parties. For example, a guidance document could explain how to prepare a report or what information should be gathered before submitting a complaint.
Good Guidance Practices
In the United States, guidance documents published by federal agencies are required to follow a set of requirements to ensure that the documents they publish are useful and accurate. These practices are referred to as "GGPs" and require specific controls. For example, agencies have to ask for public comment before publishing major guidance documents, similar to the requirements for new rules and regulations.
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