Good Documentation Practises (GDP) are the cornerstone of efficiency in a pharmaceutical company. They facilitate effective checking and preservation of data. Further, they reduce the likelihood of misuse or incorrect use of the data, according to Kaushik Desai, chairman, Industrial Pharmacy Division, Indian Pharmaceutical Association (IPA) and CEO, Global Pharmatech.

There can be no substitute for clear communication if data is correctly and chronologically entered right, the first time. GDP should be embedded into the corporate strategy because it is viewed as a rationale for responsible decision making, he added.

GDP is an evidence of straightforward implementation of records which provide data on activities for inspection audit, analysis, control & corrective measures.

The key functions of GDP are the need to establish, monitor and document quality. There is the need to classify these as descriptive documents which need to be defined to establish the quality of raw materials, environment, production process and finished product. A numbering system must be adopted to help track data collection documents, said Desai during at a presentation at the Government Pharmacy College.

The presentation, primarily targeted at pharmacy graduates and post graduates, was to make certain that students adopted a systematic approach to documentation right from the start. This would help them to be more methodical which is a key parameter for success in a pharma industry. An organised process would facilitate review and retrieval in an efficient manner, said the chairman, Industrial Pharmacy Division, IPA.

A well-designed documentation system ensures quality standards are met routinely. It minimizes error. It reduces downtime when deviations or failures occur by providing immediate access to well-organized data. Further, GDP serves as a consistent training tool for assembly line workers and administrators. In this regard, the good manufacturing practices should be prepared, reviewed, approved, distributed and archived according to written procedures. “A poorly designed system is a burden to all. A simple system is always the most difficult to design,” he said.

The principles of good documentation allows compliance with GMP regulations. It also ensures consistent quality of products. In fact, the core of GMP is the establishment of well written procedures for each step of quality operations. Documentation is used for full traceability of events, cross reference and audit trial. Written procedures provide necessary controls to minimize the changes, mix-ups and errors.

Basics of record keeping must include retaining all appropriate documents. All production, control and distribution records should be maintained for at least one year after the expiration date of the batch. For active pharmaceutical ingredients, (APIs), records should be retained for at least three years after the batch is completely distributed. In the case of over the counter (OTC) drugs without expiration dates, records should be retained for three years after distribution of the batch. During the retention period, originals or copies of records should be readily available at the manufacturing location. For imported or purchased goods, records which can promptly retrieved from another location electronically should be take-up.

According to Desai, if Good Documentation Practices are inculcated at an early stage, it would enhance professional working standards and ensure accurate data management in a pharma industry environment.