Learn all about the good documentation practice including basics, GMP document preparation, issuance and retrieval of records, recording of time, correction of entries, handling of missing entries, blank space and cancellation of GMP records.

2020年8月27日 · Good Documentation Practices: A systematic procedure of preparing, reviewing, approving, issuing, recording, storing, and archival of documents associated with GxP activities. Instruction Document:

2020年5月4日 · This guidance elaborates on the standards for the interoperable exchange of transaction 16 information, transaction history, and transaction statements required by section 582 of the 17 Federal...

Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.

It lays down guidelines for preparation, recording and correction of data and maintenance of records throughout the lifecycle of a document. It helps to understand who, when, where, why and how to complete the relevant activities and provides evidence to show whether these have been completed as expected. 3. Scope .

ICH E6: Good Clinical Practice: Consolidated Guidance (R2- Integrated Addendum) (PDF - 484 KB) Good Clinical Practice (GCP) is an international ethical and scientific quality standard for...

This white paper describes the fundamental requirements of Good Documentation Practice (GDP) routinely used within the pharmaceutical industry – as best practice standards or as a direct requirement of the Code of Good Manufacturing Practice (GMP). Why …

2023年10月2日 · Good documentation practices (GDocP) consists of a set of guidelines for creating, maintaining, and managing documents. While generally associated with the research and development of pharmaceuticals and medical devices, this set of standards isn’t confined to a specific industry.

2024年9月12日 · Good documentation practice (GDocP) is a crucial component of regulatory compliance, including data integrity assurances. Referred to in the industry as Good Recordkeeping Practice (GRK), the term good documentation practice generally involves adhering to ALCOA+ principles.

Key attributes of Good Documentation Practices (GDP), and tips to put these into action. Guidance by OHSP at the University of Rochester.