About four years ago, we implemented a system that allows us to easily track and trend 483s. For fiscal year
2005, the top reason cited on drug 483s was violation of 21 CFR Part 211.22 (d) — the regulation pertaining to quality control unit. Historically, this problem has been number two. But this year, it became number one. And it might be because we’re putting more emphasis on this regulation — the need for firms to adopt modern quality system concepts.
We recently released a draft guidance for industry pertaining to our current thinking on effective, modern quality
systems. [21 CFR Part 211.22 (d) states: “The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.”]
Another common violation pertains to process validation, which, in general, refers to the state of control of the
manufacturing operation. Is it valid? Does it consistently produce high quality products? We require extensive
documentation on the development and control of the whole process. Companies should have the ability to demonstrate at any given time that, indeed, their process is valid. The laboratory operations are often cited on 483s. There always seem to be issues with the control and validation of laboratory methods, as well as the depth and breadth of out-of-specification (OOS) investigations.
