An Easy To Understand Guide To Good Documentation Practices

It is very important to comply with the rules of Good Documentation Practices (GDP). Documentations should be concise, accurate, legible, and standardized. It is required by governing agencies, such as CFR and Eudralex, in both the US and Europe. Records concerning productions, laboratory tests, distribution, and clinical history must abide by the GDP regulations. Observing GDP is a must in completing batch records, laboratory notebooks, and any document that would be used as reference to decide on certain issues related to manufacturing and quality of products.

The challenge for documentation in a regulated environment is to come up with different processes that meet the requirements of the working environment without severely restricting the mobility of the staff which is difficult to understand among the people working in a non-controlled environment. There should be accuracy in the data entry. The correct date format for example should be taken in utmost consideration to avoid confusion and mistakes. The date 4/8/10 is read as April 8, 2010 in the US but it will be viewed as August 4, 2010 in Europe.

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.

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.