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Good Documentation Practices
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Good Documentation Practices
Aug 06, 2021
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Good manufacturing practices.
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Documents: Is the official record or report which supports and /or records the activities for development,inspection,testing handling and distribution of raw materials,inprocess materials and finished product. Logs, protocols,repors,etc..
Verified by : Person other than the original person who performs or documents the specific function, task or steps should be verify.
General Criteria : • All documents should be designed,prepared,reviewed and distributed as per current versions. • Document should be approved, signed and dated by the concerned authorized signatories.
All entries must be made only in blue ball pen. • All entries must be legible • All entries should be signed.
NO entry shall be over written. • Ditto marks are not acceptable • All the document / records should have page numbers.
GMP record should not be discarded for any reason unless the retention period expiry is reached. • If s decimal value is fraction of 1 then a zero must be placed before the decimal point. Example: record 0.55 rather than .55.
When a date is recorded, the acceptable format is DD/MM/YY only. • Time is recorded in 24:00 hour time.
Requirements for correction, unused spaces and data transcription. • Strike off the entire entry. DO NOT obliterate the original entry. • If the reason for NA is not clearly evident, a comment/justification must be provided.
All transcribed entries have to be verified for accuracy and correctness by lead personnel. • All unused spaces in the documents should be clearly addressed by writing NA in the unused space.
Reference : • WHO guideline (good data and record management practices) • ISO/IEC 27001 Information security management • MHRA (Good Manufacturing Practice Medicinal Products for Human and Veterinary Use) • USFDA (Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry)
If you want Full GMP??? Soft copy of SOP = 1.5$ (US dollar) (110 Indian rupee) Annexure per copy = 0.7$ (US dollar) (50 Indian Rupee) Contact : Email: [email protected] Telegram:+919738137533 (only for Chat)
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29. Good Documentation Practice Computer print outs taken on thermal paper or easily fading inks should be photocopied and maintained. Original shall be destroyed after verification Use polyvinyl alcohol base gum or white glue for pasting of graphs etc Use clear transparent tape for mending (patch-up). 30.
Good Documentation Practices. Good Documentation Practices. By Mr.Vikram Joshi [email protected]. " Quality is never an accident, it is the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wisest of many alternatives". DOCUMENTS: - . 10.7k views • 56 slides
0 likes • 2,803 views. AI-enhanced title. Hossen M. Faruk. Good Documentation Practice (GDP) Health & Medicine. 1 of 29. Download Now. Download to read offline. Training on Good Documentation Practices (GDP - Download as a PDF or view online for free.
Good documentation practice. Sep 23, 2012 •. 343 likes • 162,159 views. Pharmaceutical. In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it." So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP ...
Good Documentation Practices - Free download as Powerpoint Presentation (.ppt), PDF File (.pdf), Text File (.txt) or view presentation slides online. Documentation is an essential part of the quality assurance system and should exist for all aspects of GMP. Documents declare product standards and describe how to monitor, test and judge for compliance with these standards.
Documentation Documentation proves that we have followed our validated processes. It shows we know what we did, when we did it, who it was done by and why it was done. It allows traceability of every decision taken, every action carried out and every product produced. It is a critical part of cGMP. Documentation is only useful if it is 100% accurate. 'If it's not written down it's a ...
Good Documentation Practices (GDP) (1).pptx - Free download as Powerpoint Presentation (.ppt / .pptx), PDF File (.pdf), Text File (.txt) or view presentation slides online. Scribd is the world's largest social reading and publishing site.
Presentation on theme: "Good Documentation Practices"— Presentation transcript: 2 GDP is a part of GMP GDP is a part of GMP. Our aim is to follow to cGMP rules to produce quality and effective drugs. Everybody should know the cGMP rules and regulations. Everybody should be a man of GMP, i.e He must be well trained in GMP and follow the same.
Good Documentation Practices By Mr.Vikram Joshi [email protected]. " Quality is never an accident, it is the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wisest of many alternatives". DOCUMENTS: - • As discrete packages of recorded information are the tools of quality ...
Complete and accurate study documentation supports the fundamental principle of protection of study participant's safety, rights, and well-being. 23 Aug 2011. Study Documentation • Documentation should follow the course of the participant in the study: from consent process through all study visits to completion or discontinuation and why.
The document provides guidance on good documentation practices for pharmaceutical manufacturing. It discusses the importance of documentation and outlines key requirements for documents and records to ensure data integrity. These include maintaining batch records, equipment cleaning records, raw material records, production instructions ...
Good Documentation Practices (GDP) play an important role to ensure effective communication between all IMPAACT Network members, clearly illustrate document histories, and demonstrate compliance with ... • Training materials, attendance sheets, and presentations • Study-specific Manuals of Procedures • Laboratory Processing Charts ...
Good Documentation Practices - Free download as Powerpoint Presentation (.ppt), PDF File (.pdf), Text File (.txt) or view presentation slides online. Scribd is the world's largest social reading and publishing site.
Finally, practice has included include this presentation, because most corporate that were enforcement procedures to control of documents and records also need training records or documented training requirements for all of their employees. Topics for " Good Documentation Practices 101 " include: Quality System Document Requirements
Introduction The work done in Blood Transfusion centres affects the safety of donors, patients and staff and for this reason it is vital that documentation is of the highest standard. Written procedures must be followed, work done must be documented and records must be kept. The following Good Documentation Practices (GDPs) should be applied when performing daily duties across all departments.
This PPT covers Good Documentation Practices. Healthcare. 1 of 23. Download Now. Download to read offline. Importance of GMP Documentation in Pharma - Download as a PDF or view online for free.
Good Documentation Practices 2019 Sheryl Zwerski, D.N.P. Director Prevention Sciences Program Division of AIDS. Goal for Today's Meeting Summarize lessons learnedfrom recent regulatory inspectionssurrounding documentation Provide examples of inadequate documentation Provide high level summary of goals and impact Conduct an open question and answer session to address network-specific concerns
FDA definition of good documentation practices. The Food and Drug Administration (FDA) provides a clear definition of good documentation practices in the context of the pharmaceutical and medical device industries. According to the FDA, GDocP is the set of standards by which documents are created, modified, maintained, and archived. (To avoid confusion, it's worth saying that the acronym GDP ...
Good Documentation Practice (GDP) Nov 13, 2020 •. 2 likes • 1,717 views. A. AsthaNeupane. This slide is related to Good documentation Practice in Pharmaceutical Industries. It was presented in the pharmaceutical industry (Chemidrug Industry Private Ltd.) during the training session. Read more.
Good Documentation Practices found in: System Documentation Powerpoint Ppt Template Bundles, Good bye 2019 with hanging balls good ppt example, One page good governance and management practices report infographic ppt pdf document,.. Toggle Nav. Search.
Good Documentation Practices. Documents: Is the official record or report which supports and /or records the activities for development,inspection,testing handling and distribution of raw materials,inprocess materials and finished product. Logs, protocols,repors,etc.. Verified by : Person other than the original person who performs or documents the specific function, task or steps should be ...
Good documentation practices (GDocP) "If it isn't documented, it didn't happen". Documentation control is not optional; it is a legal requirement. Records and reports, along with procedures, "tell the story" of manufactured products and devices. "Good" documentation practices ensure the integrity and reliability of data.
Tejprakashsharma10. GDP presentation for the manufacturing units which supplies for food & pharma industries. Presentations & Public Speaking. 1 of 20. Download Now. Download to read offline. Good Documentation Practices ppt - Download as a PDF or view online for free.