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Feb 19, 2014

Beyond Writing It Down


David A. Gallup, Ed. D. Principal, GMPTraining.com, Inc.

By David A. Gallup, Ed. D. Principal, GMPTraining.com, Inc.

“If it isn’t written down it didn’t happen” is drummed into everyone working within the pharmaceutical industry.  But what isn’t always so apparent is:

1. What should be written down?
2. Is there a special way to do it?
3. What are some of the common pitfalls to avoid? 
4. What happens when I make a mistake?

This article will attempt to answer those four questions.

1.        What should be written down? 


Basically, any information used to capture the manufacturing, testing, packaging, holding, and distribution of drug products!  This includes, but is not limited to: 


·       Batch Records or Batch Manufacturing Records:  Documentation that captures the specific steps in manufacturing a product.

·       Distribution Records:  Documentation that captures information related to the transportation and storage of a drug product.

·       Equipment and Use Logbooks:  Documentation that captures historical maintenance or non-product specific activities related to a room or specific piece of equipment.

·       Forms:  Activity/process-specific documentation that captures important steps that are not captured elsewhere.

·       Housekeeping Logs:  Documentation that captures information related to keeping order within the facility.

·       Investigative Reports:  Documentation that captures information used to identify and correct atypical results and outcomes.

·       Laboratory Test Data/Laboratory Notebooks:  Documentation that captures product development and discovery information in the lab; in process and final product test results.

·       Training History:  Documentation that captures training events and serves as proof of an individual’s competence to perform a task. 


2.       Is there a special way to do it? 


In general, there are five principles that govern Good Documentation Practices.  Those principles maintain that documents must be true, accurate, complete, legible, and timely.  Each of these principles are discussed below: 


·       True:  When we say the first principle is True, we are saying that the person who completed the process or performed the task actually did the work—and completed the appropriate documentation.  No signature stamps are to be used and no one other than person who actually did the work signed the document.

·       Accurate:  Accuracy means that the data free from errors and mistakes.  Results are not to be guessed at or taken as an average from past calculations.

·       Complete:   All information generated from the manufacturing, testing and distribution processes must be included in the document.

·       Legible:  Legibility means that the data can be read and understood by a party other than the originator.  The information must be easily recognizable—one shouldn’t have to try and guess what the originator was writing.

·       Timely:  All entries must be written on the document at the time that the activity occurred.  Further, all entries must be written down in the order that they occurred. 


3.        What are some pitfalls to avoid? 


·              Fraudulent data or suspicion of fraud:  Fraudulent data entry most often occurs when data is “guessed” at or “put in” as close to data that falls within normal parameters of the process.  Fraudulent data also occurs when a performer also signs as a verifier.

·              Data not obtained directly from automated systems--such as from Delta V or LIM systems:  Printouts of original data generated by any automated system should be attached directly to the appropriate document.

·              Data not recorded on a timely basis:  Documents must be completed as the information is obtained.  To do otherwise is falsification of the document.  If circumstances prevent immediate documentation, you may need to ask someone to perform the documentation for you.  If this happens then both individuals who were involved in the documentation must sign or initial the document.  Back dating of records should not be tolerated.

·              Changes not dated or explained properly:  Any changes to the document must be initialed, dated and explained according to your organizations requirements. 

·              Inaccurate data:  Inaccurate data may result from such things as missing or incomplete information; inaccurately reading times, temperatures, scales or gauges or other types of errors.  These other types of errors include:

·       Date Error (DE)

·       Spelling Error (SP)

·       Calculation Error (CE)

·       Entry Error--Including transcription and transposition errors (EE)

·       Late Entry (LE)

·       Significant Figure Error (SF)

·       Rounding Error (RE)

·              Obscured original data:  When original data is not legible, the process cannot be verified or replicated.  There is no way of knowing if the data is accurate or if the step in the process or product is on target.  Original data can be obscured by correction fluid—a product that should not be in areas where drug products are manufactured, stored or tested.

·              Use of ditto marks:  Original data must always be entered on documents.  Substituting ditto marks for original data entries should not be tolerated—even if the data being entered is exactly the same as the preceding data.

·              Use of pencil:  Use of pencil may indicate falsification of data.  Pencil notations can be erased and changed.  All documentation should be made with an indelible marker according to your company standards.  Changes to documents should be made according to company standards; changes should be initialed, dated and explained.

·              Use of signature stamp:  Signature stamps shouldn’t be in the workplace.  Signature stamps allow people who did not perform or verify a process—to “sign” documents for a co-worker—in essence falsifying the data. 


4.        What happens when I make a mistake? 


Mistakes happen!  When they do: 


·              Take responsibility for your mistakes!

·              Correct your own mistakes.

o   Draw a single line through the mistake.

o   Enter the correct information in close proximity to the correction.

o   Initial and date the new entry.

·              Correct mistakes as close to the time of the original error as possible.

·              Do not obliterate the mistake – the original information must be legible!

·              Do not partially cross out mistakes; always cross-out and correct the entire entry.

·              Do not use correction fluid, erasers, or tape. 


In a GMP environment Good Documentation Practices are essential to ensure product quality and patient safety. In this article we have tried to go beyond “It if wasn’t written down, it didn’t happen” to explain some of the problems and pitfalls related to Good Documentation Practices.  By knowing the key principles of GDP and the areas where faults are most often found within documents, you should be able to develop and maintain documents that will stand up to regulatory agency scrutiny. 


David Gallup has more than 35 years' experience designing, producing and evaluating training programs and materials for the pharmaceutical, biotech, vaccine and medical device industry.  His background includes conducting needs analyses, task analyses, and evaluating training programs for client firms.  He holds a Doctor of Education degree from The Pennsylvania State University with an emphasis in curriculum design. He may be reached by phone at 215-870-5665, via email at dagallup@gmptraining.com or on his website, www.gmptraining.com.




Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.


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