Back to Basics: GDPs & Reducing Regulatory Risk (2 of 2)

Welcome back!

In Part 1 of "Back to Basicss: GDPs & Reducing Regulatory Risk", we reviewed the real regulatory impacts of not following Good Documentation Practices. We also learned an easy way to remember the basic tenets of GDPs: ALCOA!

• Attributable
• Legible
• Contemporaneous
• Original
• Accurate

To help you apply these principles when documenting data or reviewing data, I have assembled this checklist of the most common GDP issues encountered. Please feel free to use and distribute!

Common GDP Watch-outs

• Do use indelible ink for handwritten entries.
• Don't use Pencils and Erasable pen inks for handwritten entries. Should not use fountain pens or other inks that smudge easily.  
• No correction fluids (e.g. Liquid Paper) allowed!
• Ensure all raw data is kept Keep all raw data - it cannot be destroyed!
• Don't use post its, scrap paper or other uncontrolled sheets to record data.
• Entries are initialed and dated at time they are made.
• Don't back-date or forward-date your entries!
• Ditto marks or continuation lines / arrows are not acceptable.
• Don't leave spaces blank designated for handwritten entries. Cross out or "N/A" and initial/date the blank spaces.
• Don't sign for another person or sign another person's name.
• If you need to correct an error:
• Put a single line through incorrect entry, write in new entry next to it, initial and date.
• Original entry must remain visible
• Reason for correction must be recorded
• Common abbreviations for entry error reasons that can be used are: EE – Entry Error, TE – Transcription Error, OW – overwrite.

Recommendations for Official Documents

• Each page of the document should have a unique identifying number - this way if a page gets detached, it is clear what document it belongs to
• Include revision/version number and effective dates
• Securely fasten all sheets document together
• Number each page of the document (x of y)
• Label each page of the attachment with document unique identifying number and attachment number
• Define abbreviations when first used in a document
• Always remember to write your documents such that any individual with no knowledge of your work or products can pick up the document and understand the premise.

Back to Basics: GDPs & Reducing Regulatory Risk (1 of 2)

What are GDPs? Why do they matter?

Good Documentation Practices are standards by which data quality and integrity are ensured. GDP can be summed up like this: If you didn’t record it, you didn’t do it! 
This is a basic element of current Good Manufacturing Practices (cGMPs). Even though it may not be written explicitly in the Quality System Regulations (FDA 21CFR820), GDPs are most definitely a part of FDA's audits! 


Here are a few FDA audit observations that refer to GDP deficiencies identified during audits:

• Audit observation due to changes to data not dated: US FDA Form FDA 483 Observation #9A
• Warning letter specifically referring to inaccurate, incomplete and altered laboratory data, including original data being obscured and use of pencil to record data  US FDA "Warning Letter" 320-01-02
• Warning letter addressing use of correction tape, erasures and write-overs of data  US FDA "Warning Letter" to Simmons Pet Food 23-Jul-08, Observation #13b.

As you can see, Adherence to GDPs is critical to reducing your regulatory risk! GDPs are straightforward and easy to follow. This is one of the easiest ways to limit your risk of observations during an audit!

The basic tenets of GDPs can be summed up in the acronym ALCOA:

• Attributable: 
• Data must be linked to its source (equipment name, study name, patient identifier, etc) and to the individual(s) who observed and recorded the activity. If one person observed and another recorded the data, then data must be attributed to both persons. 
• If any changes are made, the individual making the changes must be clearly identified as well.
• Per FDA regulation  21CFR58.130, "All data entries shall be dated on the date of entry and signed or initialed by the person entering the data...  In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input".
• Legible: 
• If data cannot be read, then it cannot be utilized! Entries must be written clearly, with permanent ink.
• Changes to data cannot obscure the original entry - legibility applies to errors as well!
• Per FDA regulation  21CFR58.130, "Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change".
• Legibility requirements apply to electronic data as well. Per 21CFR11.10 (b), " The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency." Also in  21CFR11.10 (e), "Record changes shall not obscure previously recorded information."
• Contemporaneous:
• Data is to be recorded at time observation is made - contemporaneous with the observation.
• No back-dating! 
• Per FDA regulations 21CFR11.10 (e) "All data generated ...shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the date of entry and signed or initialed by the person entering the data."
• Original:
• First record of observation is most accurate and reliable recording of data. 
• Also known as source data or raw data
• FDA regulations 21CFR11.10 and 21CFR58.130 apply as well
• Accurate:
• Free from errors
• Data recorded as is, no modifications or falsification
• FDA regulations  21CFR11.10 and 21CFR58.130 apply as well

Even though regulatory focus of this blog entry has been on the FDA, the EU also has a guidance document on GDPs with many similar requirements:

• EU Guidance Document guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.

Stick around for part 2 of this blog entry on Friday June 22 to get a GDP checklist you can use today!

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