E-Letters are topic-specific, electronic newsletters published four times per year by ISPE's global Communities of Practice (COPs). The content for E-Letters is submitted by professionals working in the pharmaceutical industry and is a resource by which to share best practices, regulatory news, technical articles and innovative solutions to real world problems.
GAMP Named 2011 Committee of the Year
The GAMP® Community of Practice was recognized as the 2011 ISPE Committee of the Year at the ISPE Annual Meeting in November. GAMP continues to produce ISPE’s most widely distributed Guide series. More.
Updated GAMP Training Course Includes EU GMP Annex 11 and 21 CFR Part 11
The ISPE Training Course, Basic Principles of Computerized Systems Compliance Using GAMP 5, introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. Scheduled for 19-21 March 2012 at the ISPE San Diego, California training event, the GAMP course has been updated to include the latest on the revised EU GMP Annex 11 and 21 CFR Part 11. More.
GAMP Local COPs
One of the keys to success for the GAMP Community of Practice (COP) is the strong local presence it has established around the world. Partnering with local ISPE Affiliates and Chapters, local GAMP COPs translate ISPE technical documents, produce new technical content, and participate in local conferences, shows, and events. More.
Special GAMP Event – Improve Productivity with Risk-Based Systems Validation
ISPE is the only source for official GAMP® guidance. In honor of the 20th anniversary of GAMP, ISPE has collaborated with the GAMP Community of Practice (COP), Project Management, and Commissioning and Qualification COPs to help develop the “Improve Productivity with Risk-Based Systems Validation Conference,” 14-15 November in Brussels, Belgium. More.
Revision of GAMP Good Practice Guide on Testing of GxP Systems
Under development is the revision of the GAMP Good Practice Guide: Testing of GxP Systems. The Guide will provide pragmatic guidance on what and how to test. This applies to testing activities within the project phase of a system lifecycle and when making a change to a system in the operational phase. More.
Revision of GAMP Good Practice Guide on Validation of Laboratory Computerized Systems
The ISPE GAMP Good Practice Guide: Risk-Based Approach to Compliant Laboratory Computerized Systems Document (working title) will address laboratory computerized systems used within the regulated life science industries. This Guide is a revision of the GAMP Good Practice Guide: Validation of Laboratory Computerized Systems. It is intended as a supplement to GAMP 5. This Guide will provide an approach to risk assessment processes which can be used to determine a rational, scalable approach to compliance and demonstrating fitness for intended use, by building upon GAMP 5. More.
GAMP Issues Interpretation of Revised Annex 11
The GAMP Community of Practice has issued its interpretation of the revised EU GMP Annex 11 Computerised Systems, and consequential amendment of EU GMP Chapter 4 Documentation. ISPE will host a live webinar on the interpretation 19 July, 11:00 – 12:00 noon EDT. More ( 176 KB) .
20 Years of GAMP: A Reminiscence
This year marks the 20th anniversary of a fateful cup of coffee in the UK, over which a conversation took place on how to respond to the FDA’s questions about computer validation. What followed was the formation of the worldwide organization what would become GAMP. Randy Perez, Vice Chair of the ISPE International Board of Directors, reminisces. More ( 20 KB).
GAMP Conference – Improve Productivity with Risk-Based Systems Validation
ISPE is the only source for official GAMP® guidances. In honor of the 20th anniversary of GAMP, ISPE has collaborated with the GAMP Community of Practice (COP), Project Management, and Commissioning and Qualification COPs to help develop the “Improve Productivity with Risk-Based Systems Validation Conference,” to be held 12-13 September in New Brunswick, New Jersey, USA and 14-15 November in Brussels, Belgium. More.
July/August Issue of Pharmaceutical Engineering Focuses on Computer and Control Systems
This issue includes articles on MES, computer aided process engineering, data validation, controlling service oriented architectures, and Annex 11. More.
Webinar on New Revised EU GMP Annex 11
The EC announced a new revision of EU GMP Annex 11 Computerised Systems, and consequential amendment of EU GMP Chapter 4 Documentation. In an ISPE Live Webinar 13 April, computer systems expert Sion Wyn, Director, Conformity, Ltd., and Chris Clark BSc, MCQI, Head of Compliance, NAPP Pharmaceuticals, will speak on the changes, why they are required, and what your company should do to comply with these changes. More.
FDA Provides Part 11 Inspectional Assignments Update at ISPE Tampa Conference
Brian Belz of CDER’s Part 11 Working Group at the US FDA in February provided ISPE Tampa Conference attendees the latest on CFR Part 11 and CDER’s current, ongoing Part 11 Inspectional Assignments. Also noteworthy is the answer to the question: “How do Part 11 regulations and ‘predicate rule requirements’ (in CFR Part 11) apply to the electronic records created by computerized laboratory systems and the associated printed chromatograms that are used in drug manufacturing and testing?” More ( 88 KB) .
GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition) Now Available
ISPE has released the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems, a revision of the GAMP® Good Practice Guide: Validation of Process Control Systems. It provides guidance and examples on the application of the principles and framework of GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems to a wide range of systems, from basic instruments to large, complex, distributed control systems. More.
Training Course on GxP Process Control Systems Guide Makes Global Debut at ISPE Frankfurt Conference
A new, highly interactive training course to be held 14-15 April at the ISPE Frankfurt Conference will describe how to apply the concepts covered in the recently published GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems.
FDA Part 11 Inspection Assignments
A presentation discusses the next step of FDA re-examination of 21 CFR Part 11 for electronic records and signatures. FDA CDER inspectional assignments against Part 11 requirements (as described in the Part 11 Scope and Application guidance) are commencing. One objective is to evaluate industry’s compliance and understanding of Part 11, and to help decide next steps in the re-examination of Part 11. Read more ( 5 MB) .
ISO 9001: 2008 and 21 CFR 210, 211 “Working Together for Quality”
ISO 9001 and cGMPs can be brought together to augment compliance initiatives. A presentation discusses using ISO 9001:2008 to enhance your existing cGMP quality system and what you need to add to your ISO 9001:2008 quality management system to comply with 21 CFR 210, 211. Read more ( 1 MB) .
Quality Risk Management (QRM) Tool Selection: Getting to Right First Time
The quality and utility of risk-based approaches and deliverables is highly influenced by the selection of risk management tools. A presentation focuses on the often overlooked topic of error-proofing and optimizing risk management tool selection. Read more ( 1 MB) .
GAMP Poland Forum is a Success
A report gives a brief summary of the third GAMP Poland Forum, which took place in October 2010 in Wroclaw. Read more ( 30 KB) .
Pharmaceutical Engineering Focuses on GAMP
The theme of the November/December 2010 issue of Pharmaceutical Engineering magazine is GAMP. The issue includes articles on risk-based MES, application of GAMP 5, scaling of quality measures, and IT outsourcing and offshoring. Read more.
GAMP GPG: A Risk-Based Approach to Calibration Management (Second Edition) Now Available
The GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) provides guidance in setting up a calibration management system, which will give a structured approach to instrument risk assessment, calibration program management, documentation, and corrective actions, essential to regulatory compliance. Read more.
Revision of the GAMP GPG on GxP Process Control Systems
The GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition) is due for publication first quarter 2011. This new revision has been updated to reflect regulatory and industry developments since publication of the original Guide, and provides recommended good practice based on a life cycle approach for the development and management of process control systems.
The Guide recognizes that Good Engineering Practice meets most of the applicable compliance requirements. The Guide also emphasizes that in order to be efficient, appropriate specification and verification activities should be an integral part of the normal system life cycle. The Guide recognizes that many suppliers of systems now have mature quality management systems and system development, test, and support documentation. The Guide promotes the leveraging of supplier documentation and activities to avoid unnecessary duplication, cost, and waste.
New Online Course: Controls and Automation
The new online course, Facilities and Equipment: Controls and Automation, builds on your knowledge of the types of process automation and associated controls, and building management systems. Read more.