RegionWhat is GDocP in pharma?
Good Documentation Practices (GDocP) in the pharmaceutical industry refers to the set of standards and guidelines for creating, modifying, maintaining, and archiving documents related to pharmaceutical products and processes.
What are the key points about GDocP?
- It applies to a wide range of documents, including written procedures, work instructions, forms, records, logs, labels, electronic documents, laboratory notebooks, emails, and any other information that records an action, decision, or event.
- The goal of GDocP is to ensure the integrity, accuracy, and traceability of data and information related to pharmaceutical products and manufacturing processes.
- GDocP is a crucial component of regulatory compliance, as regulatory authorities like the FDA and EMA inspect pharmaceutical facilities for adherence to GDocP standards.
- Proper GDocP helps prevent errors, ensures product quality and patient safety, facilitates regulatory approvals, and supports business operations like product lifecycle management.
What are the key features of GDoCP?
The key features of Good Documentation Practices (GDocP) in the pharmaceutical industry are:
- Attributable: It should be possible to identify the individual or computerized system that performed a recorded task and when the task was performed
- Legible and Permanent: Records should be made at the time each action is performed
- Contemporaneous: Records must be made at the time each action is performed
- Original: Records should be the first capture of information, not a copy of something else
