An Easy To Understand Guide To Good Documentation Practices


An Easy To Understand Guide To Good Documentation Practices

Good Documentation Practices (GDP) is the set of activities that enable the documents to be understood by external/internal customers in support of production, laboratories, distribution, and other pharmaceutical applications. Compliance with FDA’s GLP regulations (CFR), GMP regulations as well as Eudralex require the use of Good Documentation Practices in both the United States and in Europe. This process is very crucial in filling out batch records, laboratory notebooks, and other documents necessary to facilitate the need of good judgment throughout the organization.

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?)

Another aspect to consider for good documentation is the time format. The concerned company should establish first if it would use the 24 or 12 hour clock format. The employees need to ensure that sufficient details have been submitted to provide confidence that the production method will consistently result in safe and effective products and that batch to batch consistency is achievable and whether the manufacturing method has been described in sufficient details, and whether all the critical steps in the process have been identified and controlled.

Raw data and hand-written entries should be recorded in a clear, complete, and legible manner. The use of permanent indelible ink is a must, preferably black or blue, but red ink can be used in protocol applications or in highlighting documents. The entries are considered permanent, therefore, the use of pens with erasable ink, pencils, and felt tip pens are strictly discouraged. Original documents which appear to be altered in one way or the other might void that particular entry or even the entire document.

Enter data directly into the controlled record as this is considered the original. Never enter data on scrap paper to be transcribed later. Why? If auditors see scraps of paper that look like original data, compliance to GDP is immediately questioned and can be a sticking point throughout the audit. Many companies have banned post-its notes from their companies in an effort to prevent this from happening.

Dating any document by a date earlier than the one on which the document was originally drawn up is called back dating and under most circumstances, it is seen as fraudulent and illegal. Late entries should be avoided at all times. A mistake should not be corrected by another mistake. It is always better to uphold our integrity and accept our mistakes instead of being dishonest. There are ways to correct errors that will not be causes of termination. In case of forgetting to enter the date in the previous day for example, write the current date as you log your entry and cite a short notation regarding the incident instead of alterations and intentional misinterpretations.

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