All Blog Posts (1,471)

The knowledge of combination products and their regulations is essential for regulatory professionals. This is because of the high proportion of combination products in the market, as well as the array of regulations that govern them.

21 CFR 3.2 (e) has a complete definition of a combination product. A combination product is one…

In late 2016, the US Environmental Protection Agency (EPA) revised Section 608, which deals with refrigerant management regulations. A number of requirements under this section are set to change. They concern the handling requirements that are applicable to ozone depleting refrigerants, and fortify the existing regulations by…

Microsoft OneNote is a program that works as a digital notebook. It saves users the trouble of having to scramble for a piece of paper whenever they feel like scribbling some information or idea down. Moreover, it saves the user the trouble of having to preserve a piece of paper on which the info is jotted down.

Microsoft OneNote helps users to type, write or draw on the digital notebook while continuing to have the same feel as a regular paper and pen. It is…

Following the rapid advances being made in the field of information management in the past quarter of a century or so, computers have increasingly come to replace paper as the source in which important documents are created and stored. Till the last decade of the previous century, organizations used paper to record and document information relating to their research, development and business. From around the start of the 1990’s; the shift towards computerization of paper…

The FDA has strict requirements on the way promotion and advertising practices are to be implemented by the industries that it regulates. Section 906 of the Food and Drug Administration Amendments Act (FDAAA), which came into effect in 2008 and amended the section that pertained to this topic previously, namely Section 502(n) of the Federal Food, Drug, and Cosmetic Act (FDCA); now requires that published Direct to Consumer (DTC) advertisements for prescription drugs should…

Cash management is a major component in ERP systems such as Oracle. It is a module that offers information about the most critical component of the business, namely cash flow. Cash management processes and analyzes all of the business’ cash and bank transactions from a number of sources such as:…

There is the saying that after all is said and done, to err is human. In a philosophical sense, it can have numerous interpretations, but in the field of Good Manufacturing Practice, it cannot be taken with a pinch of fatalism. GMP requires everything to be precise and scientific to a T. GMP is not an area that leaves anything to human error. Being an area of science, GMP has no place for imagination and chance.…

21 CFR Part 11 is an FDA regulation that deals with electronic records and electronic signatures. 21 CFR Part 11 has a set of FDA regulations that define the various parameters that need to go into electronic records and electronic signatures for them to be considered genuine, that is, for these records to have the same trustworthiness, reliability and equivalency as those of paper records.

Any organization has to comply with the requirements set out in…