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GMP Detox
Germany
Приєднався 1 жов 2012
EN:
Our UA-cam channel for knowledge sharing about GMP (Good Manufacturing Practice) and CSV (Computer System Validation) and other related topics. The art of being well-informed and using the correct language and terms provided by Markus Roemer (CCS).
DISCLAIMER:
The contents of this UA-cam channel "GMP Detox" are intended to provide general information only and cannot replace individual consultancy, training, coaching, or internal audits / assessments. The information is merely an interpretation and opinion and serves the purpose of portraying GXP topics and does not represent a consultancy service and cannot replace such services. There might however be some special situations were other approaches and standards must be applied. Liability for the completeness and the correctness cannot be taken. "GMP Detox" does not make any claim to be exhaustive. Regulations, standards, and guidelines are subject to constant amendment and adaptation and must be regularly verified and checked.
Our UA-cam channel for knowledge sharing about GMP (Good Manufacturing Practice) and CSV (Computer System Validation) and other related topics. The art of being well-informed and using the correct language and terms provided by Markus Roemer (CCS).
DISCLAIMER:
The contents of this UA-cam channel "GMP Detox" are intended to provide general information only and cannot replace individual consultancy, training, coaching, or internal audits / assessments. The information is merely an interpretation and opinion and serves the purpose of portraying GXP topics and does not represent a consultancy service and cannot replace such services. There might however be some special situations were other approaches and standards must be applied. Liability for the completeness and the correctness cannot be taken. "GMP Detox" does not make any claim to be exhaustive. Regulations, standards, and guidelines are subject to constant amendment and adaptation and must be regularly verified and checked.
Відео
GMP Detox GCP Data Integrity and CSV
Переглядів 68День тому
It's time for another GMP Detox Session. Today, we delve into GCP and the EMA Guideline on computerised systems and electronic data in clinical trials -a comprehensive guideline that unifies data integrity and CSV in a singular approach, as it ought to be. In GCP, data integrity and system validation extend beyond mere system testing. They form a crucial link to study protocols, risk-based moni...
GMP Detox Site Master File
Переглядів 3721 день тому
What is a Site Master File? With a funny reaction part of a "great" SMF template.
GMP Detox AI ML DL validation Edition 2024
Переглядів 1652 місяці тому
AI / ML / DL - it’s a true revolution - is it? EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines REGULATION (EU) 2024/1689 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2024 - (Artificial Intelligence Act) Classification rules for high-risk AI systems Legal act of Union harmonisation legislation The AI Act Explorer EU AI Act Compliance Checker EU-US TTC Joint Roadmap...
GMP Detox Data Literacy and PIC S PI041
Переглядів 552 місяці тому
GMP Data Literacy and PIC/S PI 041 Critical Process Parameters (CPPs) Critical Quality Attributes (CQAs)
GMP Detox WHO World Health Organisation GMP basics
Переглядів 274 місяці тому
Who is the WHO? Where to find WHO GMP guidelines? Structure of GMP guidelines and Technical Reports What is a WHO PIR - Public Inspection Report? What is a WHO NOC Report (Notice of Concern)? Other activities by the WHO - e.g. Infodemic, Trainings etc.
GMP Detox Batch Certification and Batch Release - explAIned
Переглядів 364 місяці тому
Is the Batch Certification the same as Batch Release? So often the definition and setup is wrong or misunderstood. Why? What is a Batch Certification? What is a Batch Release? Which role can do a Batch Certification, which role a Batch Release? Answers by AI Copilot - 90 % correct.....
GMP Detox Qualification and Validation - Annex 11 and Annex 15
Переглядів 3624 місяці тому
- "Qualification and Validation" explained on the basis of EU GMP Annex 11 and Annex 15 - PIC/S guidelines PI-011 and PI-006 - Validation Master Plan - PIC/S template - Equipment, Facility, Utility Qualification - Transport Verification - Process Validation - Cleaning Validation - Packaging - Validation of Test Methods - Computer System Validation - Qualification of IT infrastructure - Qualific...
GMP Detox Shorts GMP or CGMP
Переглядів 844 місяці тому
So funny, reaction on: "GMP is a set of guidelines" and "CGMP is an updated version of GMP" 😎
GMP Detox Why 3 batches for process validation?
Переглядів 274 місяці тому
What a GMP Detox session incl. reaction video about Process Validation - 3 batches approach!
GMP Detox Session CAPA Effectiveness Checks - When and How?
Переглядів 674 місяці тому
👀 Smart CAPA Effectiveness Check: - When to do it? Before you close the CAPA or after? Or both? - Is there a difference in CAPA verification and CAPA effectiveness check? - How do you do in reality the Effectiveness Check? Written down in the CAPA record itself or in the Management Review Report? - How do you analyse the effectiveness (less occurrences) and/or do you work with root cause catego...
GMP Detox: Do we need electronic signatures or digital signatures?
Переглядів 855 місяців тому
What is an electronic signature? What is a digital signature? Certificate Validity vs. Retention Period of GXP documents and records Predicate Rule US-FDA 21 CFR Part 11 - electronic signatures (closed systems) and digital signatures (open system - 1997!) Signature laws, e.g. EU Regulation (No 910/2014), Switzerland SR 943.03, US ESIGN: simple electronic signature, advanced electronic signature...
GMP Detox What is GLP and OECD and ICH guidelines
Переглядів 655 місяців тому
🔬 What is GLP? Simple question? Good Laboratory Practices (i.e. US FDA 21 CFR Part 58, ICH M4, EMA - www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-laboratory-practice-compliance) 🗿 Does it also apply to the QC laboratory at a GMP / CGMP site? ✅ Where is the link in ICH? And what is the ICH? Is it required to add GLP study reports to the...
GMP Detox Master Batch Record and Batch Production Record (GMP and CGMP Pharma)
Переглядів 775 місяців тому
😎 Maybe one of the most interesting GMP Detox Session ever made. 🔊 Based on a request we have today a view on GMP and CGMP: 🎯 Master Batch Records and Batch Production Records (terms and definitions according EU GMP Chapter 4 and US-FDA CGMP 21 CFR Part 211 - subpart J) Please subscribe to the YT channel and/or leave a comment.
GMP Detox Audit Observations and Findings?
Переглядів 495 місяців тому
GMP Detox Audit Observations and Findings?
GMP Detox Machinery regulations GMP and PCS and PLC validation
Переглядів 646 місяців тому
GMP Detox Machinery regulations GMP and PCS and PLC validation
GMP Detox 21 CFR Part 820 Medical Devices - Short Introduction
Переглядів 416 місяців тому
GMP Detox 21 CFR Part 820 Medical Devices - Short Introduction
GMP Detox SAP Validation and Process Mapping
Переглядів 1676 місяців тому
GMP Detox SAP Validation and Process Mapping
GMP Detox SW development GAMP - Does Computer System Validation improve Software Quality?
Переглядів 666 місяців тому
GMP Detox SW development GAMP - Does Computer System Validation improve Software Quality?
GMP Detox Should, Shall, Must, May, Can
Переглядів 477 місяців тому
GMP Detox Should, Shall, Must, May, Can
GMP Detox QP Certification vs Batch Release
Переглядів 787 місяців тому
GMP Detox QP Certification vs Batch Release
GMP Detox CAPA - and what are corrections?
Переглядів 647 місяців тому
GMP Detox CAPA - and what are corrections?
GMP Detox Documentation = Documents and Records
Переглядів 537 місяців тому
GMP Detox Documentation = Documents and Records
GMP Detox ICH Q9 Full Briefing Package Quality Risk Management
Переглядів 428 місяців тому
GMP Detox ICH Q9 Full Briefing Package Quality Risk Management
GMP Detox GMP Consultant Requirements
Переглядів 348 місяців тому
GMP Detox GMP Consultant Requirements
Just listened to your webcast. Really great stuff. I really enjoy how you are presenting the information.
Hi 420JE - thanks so much. Happy to read that you like it.... a lot of new GMP Detox sessions are under preparation.... I am just having not enough time before Christmas for it, because of projects and audits.... End of December and January we will continue....
Thanks for sharing, Markus! It was great having you with us in Cologne. See you next year :-)
is it possible to share the document that you are going over? I feel that is quite helpful to read and understand as the General Principles guidance doesn't have the table that you are shoing in this vide.
@@kirank2439 pls send an email to talk@comes-services.com
Thanks for bursting bubbles on surface. Planning to watch each of GMP detox 😊
Thank you.
Thank you
Thanks for sharing ✔️
very useful for me， thank you and hope to have more on SAP validation
I would argue that the open systems are very common. Let's say a company receives the CoA from a supplier and place this CoA into the system. I would consider the receiving system an open one. Access implies authorization. So, do we control the access to the system from which we received the CoA? No, we don't. But the user of that system interacts with our system. Therefore, I would say that the receiving system should accept a digitally signed document.
Thanks for your comment. According 21 CFR Part 11 - section 11.3 (9) an "open system" is defined as "Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system." - Your given example is a good use case, but exchanging information like a CoA (ref. 21 CFR Part 211.196) would not be designed on an "environment in which system access is not controlled".
Sorry, but you are not talking about EU GMP regulations but guidelines! A big legislative difference !
Thank you for your comment. You are totally right - guidelines (i.e. GMP EudraLex) are shown as example only, which are based on the corresponding regulations (e.g. Med Dev, ATMPs) or directives (EU GMP Part 1 for example) or guidelines (PIC/S) etc.
Source: SAP DM - help.sap.com/doc/sap-digital-manufacturing-in-regulated-environments-quality-and-compliance/latest/en-US/SAP%20Digital%20Manufacturing%20in%20Regulated%20Environments%20-%20Quality%20and%20Compliance.pdf
Exactly.
Thanks for Sharing
This channel is gold for anyone in pharma ‼️ Really nice content and good for refreshing memory and getting some of the background.
Glad you enjoy it!
Be Clear in Communication With A Potential Consultant Do not use abbreviations or industry slang terms without a complete description. I am reminded of the story about the „Unclear Co.“ and their client. The client requested, and placed in the contract, that the consultant was to provide services following cGMP. It was months before the consultant and the client realized that cGMP meant „current Good Manufacturing Practice“ to the client and „Gross Maximum Price“ to the consultant. Journal of Validation Technology, 1995
In particular the FDA does not approve software (independent from being compliant with e.g. GAMP) or single pieces of manufacturing or laboratory equipment. Claiming such approvals and/or use such claims for marketing purposes provokes prosecution for misbranding
informative., please share
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