Regulatory Requirements for Investigations
Have you ever had to read a sentence two, three, or even four times to understand the point being made? If so, you know how frustrating this can be. We want to avoid this problem when writing investigation reports. What is obvious to you, as the person who experienced the unexpected event, may not be obvious to a third-party reviewer such as Quality Assurance or an FDA inspector.
Current Good Manufacturing Practices (CGMPs) include specific regulations pertaining to the FDA’s expectations concerning investigations. These regulations are given in the box below. In order to maintain regulatory compliance, and more importantly, to ensure the safety of patients, we must adhere to these regulations.
|CGMP Records and Reports
21 CFR Part 211.192
Any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed
The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
Any written record of the investigation shall be made and shall include the conclusions and follow up.
Poor writing results in poor communication of the event and investigation. This makes it more difficult to learn from the event and improve processes. It also leads to more detailed questions and investigations, requiring more time from QA units and more scrutiny from third-party auditors.
Good writing results in effortless reading. It is clear and concise. It uses short sentences and simple words. It keeps to the facts and is easy to read and to understand.
Consider the following statements:
|Poorly Written Statements:
1. Due to parked cars we were not able to load materials with destination Durham NC at the good outs dock and consequently therefore we ended up needing to load material at the incoming goods dock, moving material against the GMP flow of goods.
2. This letter is just a not to be sure that you and I understand what you said would be criteria for determining the qualifications we are looking for in a new scientist.
3. Caused by discharge of the solution, the connection to the filling line had to be performed at a wetted draining valve (normally dry).
Can you understand what the writer is trying to say? This type of writing makes it difficult to learn from the discrepancy and improve. In contrast, clear writing leads to more efficient investigations, improved manufacturing processes, better system understanding, and successful audits.
In closing, if Good Writing Guidelines compliance or training is a gap or concern at your organization, don’t hesitate to reach out to Kymanox for a quick, no obligation discussion.
(Adapted from Plain Language http://www.plainlanguage.gov/howto/quickreference/quicktips.cfm)
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