Albert Science International Organization

ARTICLE DESCRIPTION: 

R. Shiphora Pillai, Arpita Biswas, Dr. Dhrubo Jyoti Sen, Tale of Good Documentation is a Sale of Pharma Marketing, ASIO Journal of Pharmaceutical & Herbal Medicines Research (ASIO-JPHMR), 6(1), 2020: 22-36.

Affiliation:

Department of Pharmaceutical Chemistry, School of Pharmacy, Techno India University, Salt Lake City, Sector-V, EM-4, Kolkata-700091, West Bengal, India

ARTICLE TYPE: Review

DOI :10.2016-19146535/ ; DOI Link :: http://doi-ds.org/doilink/06.2020-72316934/

ABSTRACT:

One of the biggest concerns that the pharmaceutical industry constantly attempts to address is the safety of its products. GxP is a collection of regulations that aim to resolve this matter in a systematic and wholesome manner. The concept of GxP requirements in Pharmaceuticals was established by the United States Food and Drug Administration. For example, 'x' is replaced by 'D' to make it GDP which represents 'Good Documentation Practice' established by the United States Food and Drug Administration. The term itself encircles many different regulations in many different fields. Data integrity has equal importance in all departments in the pharmaceutical industry from quality control to the purchasing department. The effective control and management of documentation is a critical part of the GMP program within the organization. Documentation control is not optional – it is a legal requirement. An overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented. Specific topics for discussion include documentation fundamentals, document creation, document management, best practices in style and layout, completing documents and record-keeping, electronic records, storage, errors including error correction, and associated topics. Recommendations presented should contribute to development of an effective site documentation program.

Keywords: GDP, GMP, GXP, CAPA, FDA, TGA, EMEA, Accurate, ALCOA, ALCOA+, Audit trail, Archival, Attributable, Predating/Backdating, Backup, Computerized System, Contemporaneous, Data, Data Integrity, Effective Date, Error, Electronic Records, Electronic Signature, Hybrid System/Approach, Legible, Metadata, Data Integrity, Master Controlled Documents, Original, Paper-based Data, Post-dating, Raw Data, Records, Dynamic Record Format, Static Record Format, True Copy, Prepared by/Done by/Performed by/Analyzed by/Sampled by/Calculated by, Verified by/Checked by, Reviewed by, Review, Approved by/Certified by/Authorized by, Purpose, Responsibilities, Quality Assurance   

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