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GMP Detox
Германия
Добавлен 1 окт 2012
EN:
Our RUclips 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 RUclips 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 RUclips 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 RUclips 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.
GMP Detox WHO World Health Organisation GMP basics
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.
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.
Просмотров: 6
Видео
GMP Detox Batch Certification and Batch Release - explAIned
Просмотров 1614 часов назад
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
Просмотров 5514 часов назад
- "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
Просмотров 3614 дней назад
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?
Просмотров 2014 дней назад
What a GMP Detox session incl. reaction video about Process Validation - 3 batches approach!
GMP Detox Session CAPA Effectiveness Checks - When and How?
Просмотров 4621 день назад
👀 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?
Просмотров 32Месяц назад
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
Просмотров 51Месяц назад
🔬 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)
Просмотров 56Месяц назад
😎 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?
Просмотров 41Месяц назад
How do you call it in the draft audit report - audit findings or audit observations? How to get the best results out of your audit? Writing of observations: Fair, balanced, and non-inflammatory language Audit Response Letter and CAPA references / tracking Categories of observations Final Audit Report / Summary Report
GMP Detox Org Charts GMP
Просмотров 39Месяц назад
GXP Org Charts and Management Key Personnel and GXP regulations / directives (Pharma and Med Dev) Org Chart / Structure Types Organisation - Functions and Process Roles Organisational Changes - Change Request - GMP relevant? (ICH Q9 - 2023) Job Descriptions and Responsibilities SOPs and Process Mapping incl. User Group Rights Organisations and structure - 9 Levels approach
GMP Detox Machinery regulations GMP and PCS and PLC validation
Просмотров 572 месяца назад
Now we unlock the last hidden secrets of validation of machinery, production machines, automation, PLC, PCS or however it is called.... Machinery Regulation (EU) 2023/1230 (replacing Directive 2006) ISPE GAMP Good Practice Guide - Validation of Process Control Systems Validation supporting materials from suppliers and ISA 88
GMP Detox 21 CFR Part 820 Medical Devices - Short Introduction
Просмотров 352 месяца назад
Current applicable 21 CFR Part 820 requirements (predicate rule) / process map Different US-FDA offices - medical devices and drugs/medicines Combination Product (21 CFR Part 4) - Guidance for Industry (recommondations) Updated 21 CFR Part 820 - coming in February 2026 - What's new? How to find and navigate: Regulations eCFR and Federal Register Notices MDSAP information and audit approach
GMP Detox SAP Validation and Process Mapping
Просмотров 1132 месяца назад
GMP Detox session about ERP SAP Validation (GMP / CGMP) Annex 11 and Part 11 SAP White Paper SAP Digital Manufacturing Atlassian Jira SAP Solution Manager Release, requirements, test management & deployment ISPE GAMP 5 - second edition - Appendix M12 - Critical Thinking Process Mapping - SIPOC Data Flow Diagrams
GMP Detox SW development GAMP - Does Computer System Validation improve Software Quality?
Просмотров 582 месяца назад
According PIC/S PI 011 Supplier Audits ISPE GAMP 5 history Testing phases at supplier site and end users Unit / Integration / System and Acceptance Testing Validation and SDLC (Software Development Life Cycle) SDLC methodologies (e.g. CMMI, Scrum etc.) Using tools during validation (i.e. Atlassian) Internal Quality Management System for Software Development
GMP Detox Should, Shall, Must, May, Can
Просмотров 433 месяца назад
GMP Detox Should, Shall, Must, May, Can
GMP Detox QP Certification vs Batch Release
Просмотров 533 месяца назад
GMP Detox QP Certification vs Batch Release
GMP Detox CAPA - and what are corrections?
Просмотров 533 месяца назад
GMP Detox CAPA - and what are corrections?
GMP Detox Documentation = Documents and Records
Просмотров 443 месяца назад
GMP Detox Documentation = Documents and Records
GMP Detox ICH Q9 Full Briefing Package Quality Risk Management
Просмотров 344 месяца назад
GMP Detox ICH Q9 Full Briefing Package Quality Risk Management
GMP Detox GMP Consultant Requirements
Просмотров 334 месяца назад
GMP Detox GMP Consultant Requirements
GMP Detox Reviewed by or Check by or Verify by
Просмотров 464 месяца назад
GMP Detox Reviewed by or Check by or Verify by
GMP Detox GAMP ® Enabling Innovation - for sure
Просмотров 314 месяца назад
GMP Detox GAMP ® Enabling Innovation - for sure
GMP Detox US FDA Inspections or Audits?
Просмотров 844 месяца назад
GMP Detox US FDA Inspections or Audits?
GMP Detox 21 CFR Part 11 Time Travel
Просмотров 1365 месяцев назад
GMP Detox 21 CFR Part 11 Time Travel
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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