Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent.
Good Documentation Practices are essential for a number of disciplines. The soul of documentation is, naturally, the written word. What happens when something that happened is not actually written down? It is a work of no practical use, because apart from those that carried out the particular undocumented task; no one else is aware of it. And even when the people who did that task or were witness to it are prone to have their own interpretation and perception of what was done. This is why proof in the form of writing is the most important element of Good Documentation Practices.
What to write, and how toGDP should not only be about just writing down; it is about what to write and also, how, meaning, in what manner. If there has been an intervention in any method of manufacture or any other activity in the regulated industries; the change should be noted down in the proper format as prescribed by the FDA. This enables everyone concerned, from the people in the organization to the auditors to the regulatory agencies, to clearly identify what action was carried out, by whom and when. This further leads to a discovery of the impact of the actions. This is the key to determining the effectiveness of the application of the GDP principles in the particular case.
This is why the FDA has very clear-cut requirements and expectations of GDP from the industries it regulates. These clearly explain the method by which to document the said document, the ways of doing it, and what actions to take when the need arises.
Quality Assurance is unthinkable without the application of GDP principles. The main reason for establishing GDP is ensure that the documentation does the following to the record in question:
What needs to be documented?Another major element of GDP is to determine what is to be documented. The FDA and other regulatory agencies require the principles of Good Documentation Practices to be applied across a number of activities at different stages. These include:
The EMA also has clear-cut guidelines on Good Documentation Practices. Some of its core requirements relate to
- All aspects of the manufacturing including the product’s formulae, the way in which the processing was done, the methods of its packaging, and the extent to which its testing instructions are written down
- Technical agreements
Further, most regulatory agencies have their own requirements with regard to the styling, ways by which the amendments, if any, need to be jotted down, the type of ink to be used, the way in which the review, if any, needs to be entered, and who should put signatures and where, so on. Manufacturers who fall under the purview of respective regulatory agencies need to adhere to these.
And, for other reasons, as wellImplementing Good Documentation Practices is a great idea to have for meeting regulatory requirements, because companies that do not meet these requirements are in a spot of bother about a number of issues. However, in addition to this, there is also the need for maintaining GDP for business reasons, as well. A business that complies with the requirements set out by the FDA or other regulatory agencies in relation to Good laboratory practices, the CFR regulations such as 21 CFR Parts that apply to various industries, and also as required as part of national and global agencies; earns a good name in the market and is considered a reliable company.