An Easy To Understand Guide To Good Documentation Practices

The use of Good Documentation Practices (GDP) is required in both the US and Europe by governing bodies, including CFR and Eudralex. Any documentation that is used in support of manufacturing, laboratory, distribution, and clinical practices must adhere to GDP. Good documentation practices or (GDP for short) is essential when filling out batch records, laboratory notebooks or any other document that is used to make any quality decision within the manufacturing or quality environment.

Good documentation practices can include many different aspects of documentation that are not considered important by individuals who are not working in a regulated environment. For example using the correct date format is essential when you are filling in important documentation. The date format used in the US is different to that used in Europe. For example 08/07/10 would be considered August 7, 2010 in the US but July 8, 2010 in Europe. (Should the years be 2010?)

The time format also has to be considered an essential aspect of good documentation practices when dealing with complexed make-ups in the pharmaceutical manufacturing area. The organization in question needs to decide what format they are going to use, whether they decided to use the 24 or 12 hour clock. Each employee needs to understand how important this is when medicinal batches are being prepared for public consumption.

The type of pen you use in a regulated environment is also very important; all entries must be clear, complete and legible so make sure you use permanent indelible ink. Black or blue ink is usually the norm, however red may be used while executing protocols or marking up (red-lining) documents. Do not use pens with erasable ink, do not use pencils and do not use felt tip pens either. If the original data appears as though it has been erased or isn’t complete, this may cause the document or record to be considered unacceptable or at least not wholly trusted.

Controlled records are compilations of original entries. Data should be entered directly as the circumstances happen. There should be no rough draft or writing on scrap paper to save the information until later. The discovery of such actions by the auditor, moreover if the scraps of papers will as originals, will negatively affect the GDP compliance. As a result, this will be a ground for questioning and unreliability throughout the entire auditing process. Post-it notes are not allowed in many companies to avoid this scenario.

There should be no back dating or post dating. The date adjacent to a signature indicated the date of the signature unless specifically noted otherwise. If some records come in where the dates do not match up, this will serve as a red flag to regulatory agencies and they will dig deeper into recordkeeping practices. Therefore, make sure all dates reflect the exact sequence of events. Corrections can be made instead of performing the act of dishonesty that can lead to termination .In cases wherein you have forgotten to enter the date and you have to enter it the next day, write the current date. A note to explain the fact is appropriate. Remember to initial and date the note. Never compromise your integrity and honesty is still the best policy.

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