The use of Good Documentation Practices (GDP) is a critical requirement for successful pharmaceutical or medical device development and approval .Yet GDPs are still being overlooked. Here are the most prevalent mistakes that continue to delay products to market.
NAVIGATING THE FUNDAMENTALS
Good Documentation Practices are essential to successfully bring therapies or medical devices to market. GDPs is the cornerstone to Good Manufacturing Practices (GMP) and ensures that regulatory compliance record requirements are met.
There are two fundamental rules to GDP recordkeeping:
- If it’s not signed and dated, it’s not documented.
- If it’s not documented, it wasn’t done.
While these two fundamental rules may appear simple at first, when applied, many companies still experience issues surrounding GDP. In this article, the following common pitfalls will be discussed in further detail.
- Time Date Stamps
- Significant Digits
- Corrections
- Blank Fields
TIME DATE STAMPS
Time date stamps are imperative to building an accurate record or timeline for a sequence of events when manufacturing your product. For this reason, time date stamps are one of many facets subject to scrutiny when executing any sort of official testing. All protocols must be fully approved prior to the execution of any test activities. After the protocol is approved, all operators executing the protocol must have documented training. During execution, all steps are signed and dated at the time the work is completed. Results are recorded on the date work is performed using approved data sheets (not on scratch paper or sticky notes.) In addition, supporting documentation e.g., equipment records, sterilization reports, work order builds, etc. should be correctly filled out with time date stamps for all activities. All supporting documentation should then be attached to the report when the report is routed for approval.
Date formats are dependent on company guidelines, however, best practice default is a format that explicitly states the day, month, and full year:
DD-MMM-YYYY (ex: 14-DEC-2020).
SIGNIFICANT DIGITS
While the term “significant digits” or “sig figs” may seem like a blast from the past back to your high school chemistry days. Significant digits play a major role in GDP. The resolution for significant digits will be established within the protocol and also by the measuring equipment/system used to capture the data. Therefore, the lowest significant digit can dictate the resolution for the entire study. It’s also important to keep in mind that test equipment can have more resolution than needed and the report writer should be mindful of how many significant digits to report (for example, many Instron machines can report up to 4significant digits for tensile strength). It should also be noted that it is best practice for inspection records and data to be recorded using decimals and not fractions.
CORRECTIONS
It’s natural for mistakes to happen. Corrections to documents must be performed in a specific format per GDP.
- Fully cross out entire incorrect entries using the CLIDE method:
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- CLIDE (Correct, [single] Line, Initial, Date, Explain)
- Do not overwrite text.
- Never use correction fluid (white-out).
- Never use ditto marks for repetitive entries.
- All comments must be reviewed and dated.
BLANK FIELDS
When populating a form or record never leave a cell or line blank. In the instance where data or information is not available, it's best to follow the format below to ensure that GDP practices are being met.
- N/A and cross out form entries that are not relevant, or where information is not available.
- For sections with form entries that are in a tabular format, a single line can be used to mark all spaces and N/A can be written along the line.
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- Remember to initial and date.
In conclusion, Good Documentation Practices act as a foundation to bringing medical devices to the market. If a form wasn’t signed and/or dated then it wasn’t documented, and if something wasn’t documented then the activity technically never happened. To best avoid common issues with GDP it is recommended that you set aside time to fully review documents, both for the content, and to ensure that proper GDP techniques were utilized in origination of the information. Think of the four-eyes principle when reviewing documentation where two separate people must approve the activity (the one who performs the task, and the one who signs off). Follow the guidelines outlined in this article for a more seamless process of getting new therapies to market.
Source:
https://www.networkpartnersgroup.com/images/2023/GoodDocumentationPracticesAQuickGuidetoTipsTricksand