Good Documentation Practices (GDP/GDocP)

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What are Good Documentation Practices?

Good documentation practices, abbreviated as either GDP or GDocP, is a set of standards for highly regulated industries, like the pharmaceutical or medical device industry, that outlines how documents relating to the production and supply chain are created, maintained, and controlled.

Typically, the process for following and maintaining GDocP looks like:

Creation

For life science companies creating a new product, whether it’s a medical device or drug therapy, proper documentation describing the product must be created at the same time to ensure real time accountability. To ensure accuracy, all documentation must be error free before the translation process. For high-quality translation, the medical documents must be created in a timely fashion, with linguistic review and approval for technical accuracy.

Approval

For the medical documentation to have proper verification of accuracy, they must be approved, signed off, and dated in each target language by authorized individuals

Maintenance

To ensure all documentation is up to date with regulatory and safety standards, they must be regularly reviewed. Protecting data privacy is key throughout the translation process, but particularly in the regular maintenance of the documents, so ensuring they are version controlled, securely backed up, and password protected are all crucial components for ensuring security.

Management

Anytime a document is altered, a revision history must be maintained and reason for the modification recorded. A clear process must be established to ensure that previous versions of the documents are unintentionally used, and the updated version is available for future review.

Doing so not only ensures that safety and industry standards are being met, but that the products can be traced and monitored with proper accountability. Regulatory bodies like the WHO FDA, TGA , WHO, EMA, and Health Canada, all require and enforce compliance. The FDA specifically requires GDocP for Good Manufacturing Practices (GMP) that oversee the Good Laboratory Practices (GLP), such as  regulations like 21 CF Part 58, and medical device directives like 21 CFR Parts 211 and 820.

Proper adherence to GDocP guidelines ensures consistency and success with regulatory body compliance; the FDA has cited that when conducting regulatory audits, inadequate compliance with GDocP standards remains as one of the biggest reasons life science companies fail inspections. In addition, by maintaining clear documentation throughout the product’s lifecycle, GDocP allows for better analysis for improvements in product quality and cost savings for businesses. Furthermore, establishing GDocP is essential for life science businesses looking to obtain the necessary ISO certifications to manufacture and produce their products, making the implementation and compliance of GDocP critical for success.

Advanced Solutions for Translating GDP/GDocP

Part of the importance in choosing a language service provider (LSP) is ensuring that they adhere to following GDocP. For all parties involved in the production and supply chain for the product, including vendors and contractors, following GDocP is mandated by regulatory bodies to ensure safety and compliance. To make matters more complex, while many of the documents involved in the production and supply chain for life science companies are electronic, sometimes there are handwritten entries or video and audio recordings that require high-quality and technically accurate translation. To avoid audit failures, finding a partner that has experience and understands GDocP for all document and content types is crucial in ensuring success of the product when entering into the local market.

 

CSOFT works with life science companies to ensure that proper GDocP compliance is followed for all document types. As an ISO certified company for 9001:2015 and ISO 13485:2016, with compliance for ISO 17100 and leveraging best practices from ISO 27001, we understand the importance of following GDocP throughout the product’s lifecycle. Through our advanced language technology, including our cloud-based management system, we streamline the document management process, enabling companies in the life sciences the ability to hold all their GDocP documents in one place.

Learn more about our medical translation solutions.

 

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