Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech®
Documentation is a “record” or “evidence” of an event that has happened. In the life-science industry “If it isn’t documented, it didn’t happen”. Good Documentation Practices (GDP) are how you prove it happened.
Regulatory Agencies across the world stress the importance of Good Documentation Practices through various laws, regulations, and guidance documents. Good Documentation Practices are a key aspect of a good quality management system. GDP is also an effective way to avoid your company getting Warning Letters or 483 citations. GDP is applicable for all industries, not just those that manufacture regulated products such as drugs, medical devices, biologics, cosmetic, food products.
GDP can be implemented in different ways, some of the most common methods are:
1) Ensure all the processes are documented in a clear manner with data that is reliable and accurate: GPD practices run on the very widely followed concept called ALCOA, processes that assure that your data is Attributable, Legible, Contemporaneous, Original and Accurate. Management need to assess the capabilities of the company and implement documentation practices that accurately reflect their processes and perform in a reproducible and consistent manner.
2) Tracking Changes and Reporting Deviations: You must report, investigate, and resolve changes or deviations in your process. Good documentation practices helps to track changes, ensures easy reporting of any defects as well as promote continuous improvements to the processes that can be recorded real time.
3) Robust Electronic System to Replace Paper: You can do GDP on paper. It is so much easier with a validated electronic quality management system. You can develop systems that can collect, process, and maintain the vast array of data, reports, protocols and all other documentation that is proof of their quality standards. Such systems also help maintain an audit trail, enable electronic signatures and tracking of approval of various documents real-time.
4) Archival of documents: A record you can’t keep isn’t a record. Various regulations and guidance documents address proper archival of records. Remember, if it isn’t documented or you can’t find the record, it didn’t happen!
5) Training Personnel: Train your personnel on GDP. It is essential to implement a quality compliant culture within your company. An electronic Quality Management System can also do and document your training.
6) Centralized Database for all relevant stakeholders: A centralized database for all stakeholders involved with the process such as suppliers, vendors, manufacturers, quality assurance personnel, regulatory affairs team, while also making it easy for companies to maintain one system for all their process requirements.
PSC’s® software solutions such as ACE® (Adaptive Compliance Engine®) and ACE Essentials™ are fully integrated, validated, centralized electronic Quality Management Systems that have been helping many life- science companies on all the essential aspects of GDP.
GDP is one of the first few critical steps in implementing a robust quality management system that ensures that your company delivers high quality products in a consistent manner.
Guidance documents for reference:
ICH Q7 guideline: Good Manufacturing Practices for Active Pharmaceutical Ingredients
Annex 5: World Health Organization, Guidance on good data and record management practices