Difference between revisions of "Good Automated Manufacturing Practice"
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[[File:Pharma-production.jpg||thumb|300px|right|The area of automated pharmaceutical manufacturing is influenced in part by GAMP and its associated guidelines.]] | [[File:Pharma-production.jpg||thumb|300px|right|The area of automated pharmaceutical manufacturing is influenced in part by GAMP and its associated guidelines.]] | ||
'''Good Automated Manufacturing Practice''' ('''GAMP''') is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.<ref name="ISPEGlossary1">{{cite web |url= | '''Good Automated Manufacturing Practice''' ('''GAMP''') is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.<ref name="ISPEGlossary1">{{cite web |url=https://ispe.org/glossary/g?title_contains=Good+Automated+Manufacturing+Practice&langcode=All |title=ISPE Glossary of Pharmaceutical and Biotechnology Terminology - Good Automated Manufacturing Practice (GAMP) |publisher=International Society for Pharmaceutical Engineering |accessdate=15 April 2020}}</ref> One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production, from the raw materials, facility, and equipment, to the training and hygiene of staff. | ||
GAMP is largely about automated system validation. In October 2014, Irish tech company Dataworks Ltd. described it as such<ref name="DWDef">{{cite web |url=http://www.dataworks.ie/ | GAMP is largely about automated system validation. In October 2014, Irish tech company Dataworks Ltd. described it as such<ref name="DWDef">{{cite web |url=http://www.dataworks.ie/gamp-5-are-you-up-to-date-with-the-latest-validation-best-practices/ |title=GAMP 5: Are you up to date with the latest Validation Best Practices? |publisher=Dataworks Ltd |date=15 October 2014 |accessdate=15 April 2020}}</ref>: | ||
<blockquote>It is a formal process of thorough documentation, testing, and logical process steps that validate clients' required specifications. The process begins with a user requirements specification for the machine, from which a functional requirement and a design specification are created. These documents then form the basis for the traceability matrix and for the formal testing of internal acceptance, factory acceptance, and site acceptance. Categorising software is used to support the approach to validation based on the difficulty and individuality of the computerised system.</blockquote> | <blockquote>It is a formal process of thorough documentation, testing, and logical process steps that validate clients' required specifications. The process begins with a user requirements specification for the machine, from which a functional requirement and a design specification are created. These documents then form the basis for the traceability matrix and for the formal testing of internal acceptance, factory acceptance, and site acceptance. Categorising software is used to support the approach to validation based on the difficulty and individuality of the computerised system.</blockquote> | ||
==History== | ==History== | ||
GAMP's origins can be traced to the United Kingdom in 1988, when software developers David Forrest and Colin Jones, through their company FJ Systems, developed real-time control and production information management control systems for pharmaceutical manufacturers. They worked with ICI Pharmaceuticals' Tony Margetts on the problem of validating systems that were increasingly becoming more software-based than mechanical- and electrical-based. This culminated in a five-page document called ''VMAN I'', mapping the older installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) phases of equipment validation to a more modern software validation lifecycle. A second version was created upon additional feedback.<ref name="Forrest">{{cite web |url=http://www.controlling-compliance-matters.com/?p=190 |title=What is GAMP and how did GAMP start? |author=Forrest, | GAMP's origins can be traced to the United Kingdom in 1988, when software developers David Forrest and Colin Jones, through their company FJ Systems, developed real-time control and production information management control systems for pharmaceutical manufacturers. They worked with ICI Pharmaceuticals' Tony Margetts on the problem of validating systems that were increasingly becoming more software-based than mechanical- and electrical-based. This culminated in a five-page document called ''VMAN I'', mapping the older installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) phases of equipment validation to a more modern software validation lifecycle. A second version was created upon additional feedback.<ref name="Forrest">{{cite web |url=http://www.controlling-compliance-matters.com/?p=190 |archiveurl=https://web.archive.org/web/20150209215737/http://www.controlling-compliance-matters.com/?p=190 |title=What is GAMP and how did GAMP start? |author=Forrest, D. |work=Controlling Compliance Matters |date=01 September 2013 |archivedate=09 February 2015 |accessdate=15 April 2020}}</ref> | ||
GAMP itself was eventually founded in 1991 (with the previously mentioned Margetts as chairman of the editorial board) to deal with the evolving U.S. [[Food and Drug Administration]] expectations for | GAMP itself was eventually founded in 1991 (with the previously mentioned Margetts as chairman of the editorial board) to deal with the evolving U.S. [[Food and Drug Administration]] expectations for Good Manufacturing Practice (GMP) compliance of manufacturing and related systems.<ref name="Smith20th">{{cite journal |url=http://www.pharmtech.com/node/230212 |archiveurl=https://web.archive.org/web/20150404050745/http://www.pharmtech.com/node/230212 |title=20th Anniversary Special Feature: Validation and qualification |journal=Pharmaceutical Technology Europe |volume=20 |issue=2 |author=Smith, P. |date=01 December 2008 |archivedate=04 April 2015 |accessdate=15 April 2020}}</ref> GAMP published its first draft guidance in February 1994, with version 1.0 of it arriving in March 1995. Soon afterwards the organization entered into a partnership with ISPE, formally becoming part of ISPE in 2000. GAMP 4 was released a year later, followed by GAMP 5 in 2008.<ref name="GGuide">{{cite web |url=http://www.ssfa.it/allegati/GDL_GIQAR_GCP_GampGuidelineMilano06.pdf |archiveurl=https://web.archive.org/web/20150318190447/http://www.ssfa.it/allegati/GDL_GIQAR_GCP_GampGuidelineMilano06.pdf |format=PDF |title=GAMP Guideline & Validation Documentation |author=Maruccia, D. |publisher=Pharma Quality Europe |date=21 March 2006 |archivedate=18 March 2015 |accessdate=15 April 2020}}</ref> GAMP has enjoyed the support of numerous regulatory authorities over the years spanning the United States, Europe, and Japan and is now a recognized good practice worldwide.<ref name="DeSpautzGAMP">{{cite web |url=http://www.pharmpro.com/Articles/2008/03/GAMP-Standards-For-Validation-Of-Automated-Systems/ |archiveurl=https://web.archive.org/web/20101226195015/http://www.pharmpro.com/Articles/2008/03/GAMP-Standards-For-Validation-Of-Automated-Systems/ |title=GAMP Standards For Validation Of Automated Systems | author=DeSpautz, J.; Kovacs, K.D.; Werling, G. |work=Pharmaceutical Processing |date=11 March 2008 |archivedate=26 December 2010 |accessdate=15 April 2020}}</ref> | ||
In 2017, the leadership of the ISPE GAMP Community of Practice (CoP) began formal review of the GAMP 5 standard, whether its objectives were being met, and what more needs to be done to improve it. "For each GAMP 5 section and appendix, the team examined the effects of technical and regulatory updates since the original publication, focusing on substantive topics and guidance rather than background, historical, or supporting information."<ref name="WynGAMP18">{{cite web |url=https://ispe.org/pharmaceutical-engineering/may-june-2018/gamp-5-ten-years |title=GAMP 5: Ten Years On |author=Wyn, S. |work=Pharmaceutical Engineering |date=May/June 2018 |accessdate=15 April 2020}}</ref> That review revealed that while GAMP 5 was still relevant in the changing regulatory atmosphere, improvement was suggested in<ref name="WynGAMP18" />: | |||
* increasing the ubiquity of third-party service providers; | |||
* updating methods and approaches to software development; and | |||
* encouraging increased use of more automated tool-based processes. | |||
==Publications== | ==Publications== | ||
===GAMP 5=== | ===GAMP 5=== | ||
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is ''The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture''. The last major revision (GAMP 5) was released in February 2008.<ref name="GAMP5">{{cite web |url=http://www.ispe.org/gamp5 |title=GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems |publisher=International Society for Pharmaceutical Engineering |accessdate= | ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is ''The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture''. The last major revision (GAMP 5) was released in February 2008.<ref name="GAMP5">{{cite web |url=http://www.ispe.org/gamp5 |archiveurl=https://web.archive.org/web/20170522232540/http://www.ispe.org/gamp5 |title=GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems |publisher=International Society for Pharmaceutical Engineering |archivedate=22 May 2017 |accessdate=15 April 2020}}</ref> | ||
The guidance generally states that pharmaceutical computer systems should be built with several key ideas in mind<ref name="JohnsPre">{{cite web |url= | The guidance generally states that pharmaceutical computer systems should be built with several key ideas in mind<ref name="JohnsPre">{{cite web |url=https://www.slideshare.net/ProPharmaGroup/overview-of-computerized-systems-compliance-using-the-gamp-5-guide |title=Overview of Computerized System Compliance Using the GAMP 5 Guide |author=John, J. |publisher=ProPharma Group |date=17 April 2013 |accessdate=15 April 2020}}</ref>: | ||
1. Make product and process understanding clear. | 1. Make product and process understanding clear. | ||
| Line 28: | Line 34: | ||
====System categorization==== | ====System categorization==== | ||
Software systems borne from these principles can be categorized into one of four GAMP 5 categories. ('''Note''': "Category 2: Firmware" was removed from GAMP with revision five.) These classifications act as built-in risk and difficulty assessments that support different validation approaches<ref name="DWDef" /><ref name="JohnsPre" /><ref name="GAMPCats">{{cite web |url=http://www.spectroscopyonline.com/understanding-and-interpreting-new-gamp-5-software-categories |archiveurl=https://web.archive.org/web/20150621071044/http://www.spectroscopyonline.com/understanding-and-interpreting-new-gamp-5-software-categories |title=Understanding and Interpreting the New GAMP 5 Software Categories |author=McDowall, R. D. |work=SpectroscopyOnline.com |publisher=Advanstar Communications Inc |date=01 June 2009 |archivedate=21 June 2015 |accessdate=15 April 2020}}</ref>: | |||
Software systems borne from these principles can be categorized into one of four GAMP 5 categories. These classifications act as built-in risk and difficulty assessments that support different validation approaches<ref name="DWDef" /><ref name="JohnsPre" /><ref name="GAMPCats">{{cite web |url=http://www.spectroscopyonline.com/understanding-and-interpreting-new-gamp-5-software-categories |title=Understanding and Interpreting the New GAMP 5 Software Categories |author=McDowall, R. D. |work=SpectroscopyOnline.com |publisher=Advanstar Communications Inc |date=01 June 2009 |accessdate= | |||
Category 1: Infrastructure software - This includes "established or commercially available layered software" and "infrastructure software tools" that are themselves validated from within rather than from the infrastructure. | Category 1: Infrastructure software - This includes "established or commercially available layered software" and "infrastructure software tools" that are themselves validated from within rather than from the infrastructure. | ||
| Line 38: | Line 43: | ||
Category 5: Custom applications - This includes any "application, module, user-defined program, or macro" that has been written in-house or by a third party that "needs to be specified, version controlled, built, and tested (including integration testing with the commercial application, as applicable) as a minimum to ensure the quality of the software." | Category 5: Custom applications - This includes any "application, module, user-defined program, or macro" that has been written in-house or by a third party that "needs to be specified, version controlled, built, and tested (including integration testing with the commercial application, as applicable) as a minimum to ensure the quality of the software." | ||
===Other guides=== | ===Other guides=== | ||
As of | As of April 2020, the ISPE has 13 guides, the latest published in May 2019, titled ''Data Integrity - Manufacturing Records''.<ref name="GAMPPubs">{{cite web |url=https://ispe.org/publications/guidance-documents |title=Guidance Documents |publisher=International Society for Pharmaceutical Engineering |accessdate=15 April 2020}}</ref> | ||
==External links== | ==External links== | ||
* [ | * [https://ispe.org/ International Society for Pharmaceutical Engineering (ISPE) website] | ||
* [http://www.ssfa.it/allegati/GDL_GIQAR_GCP_GampGuidelineMilano06.pdf GAMP 4 guide] (PDF) | * [https://web.archive.org/web/20150318190447/http://www.ssfa.it/allegati/GDL_GIQAR_GCP_GampGuidelineMilano06.pdf GAMP 4 guide] (PDF, archived) | ||
* [ | * [https://www.slideshare.net/ProPharmaGroup/overview-of-computerized-systems-compliance-using-the-gamp-5-guide Overview of GAMP 5 guide] | ||
==References== | ==References== | ||
{{Reflist|colwidth=30em}} | |||
<!---Place all category tags here--> | <!---Place all category tags here--> | ||
[[Category: | [[Category:Manufacturing and R&D industry]] | ||
[[Category:Production standards]] | |||
Latest revision as of 15:14, 20 September 2022
Good Automated Manufacturing Practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.[1] One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production, from the raw materials, facility, and equipment, to the training and hygiene of staff.
GAMP is largely about automated system validation. In October 2014, Irish tech company Dataworks Ltd. described it as such[2]:
It is a formal process of thorough documentation, testing, and logical process steps that validate clients' required specifications. The process begins with a user requirements specification for the machine, from which a functional requirement and a design specification are created. These documents then form the basis for the traceability matrix and for the formal testing of internal acceptance, factory acceptance, and site acceptance. Categorising software is used to support the approach to validation based on the difficulty and individuality of the computerised system.
History
GAMP's origins can be traced to the United Kingdom in 1988, when software developers David Forrest and Colin Jones, through their company FJ Systems, developed real-time control and production information management control systems for pharmaceutical manufacturers. They worked with ICI Pharmaceuticals' Tony Margetts on the problem of validating systems that were increasingly becoming more software-based than mechanical- and electrical-based. This culminated in a five-page document called VMAN I, mapping the older installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) phases of equipment validation to a more modern software validation lifecycle. A second version was created upon additional feedback.[3]
GAMP itself was eventually founded in 1991 (with the previously mentioned Margetts as chairman of the editorial board) to deal with the evolving U.S. Food and Drug Administration expectations for Good Manufacturing Practice (GMP) compliance of manufacturing and related systems.[4] GAMP published its first draft guidance in February 1994, with version 1.0 of it arriving in March 1995. Soon afterwards the organization entered into a partnership with ISPE, formally becoming part of ISPE in 2000. GAMP 4 was released a year later, followed by GAMP 5 in 2008.[5] GAMP has enjoyed the support of numerous regulatory authorities over the years spanning the United States, Europe, and Japan and is now a recognized good practice worldwide.[6]
In 2017, the leadership of the ISPE GAMP Community of Practice (CoP) began formal review of the GAMP 5 standard, whether its objectives were being met, and what more needs to be done to improve it. "For each GAMP 5 section and appendix, the team examined the effects of technical and regulatory updates since the original publication, focusing on substantive topics and guidance rather than background, historical, or supporting information."[7] That review revealed that while GAMP 5 was still relevant in the changing regulatory atmosphere, improvement was suggested in[7]:
- increasing the ubiquity of third-party service providers;
- updating methods and approaches to software development; and
- encouraging increased use of more automated tool-based processes.
Publications
GAMP 5
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The last major revision (GAMP 5) was released in February 2008.[8]
The guidance generally states that pharmaceutical computer systems should be built with several key ideas in mind[9]:
1. Make product and process understanding clear.
2. Approach the life cycle from the standpoint of a quality management system.
3. Make life cycle activities scalable.
4. Ensure quality risk management is science-based.
5. Leverage supplier involvement into the system.
System categorization
Software systems borne from these principles can be categorized into one of four GAMP 5 categories. (Note: "Category 2: Firmware" was removed from GAMP with revision five.) These classifications act as built-in risk and difficulty assessments that support different validation approaches[2][9][10]:
Category 1: Infrastructure software - This includes "established or commercially available layered software" and "infrastructure software tools" that are themselves validated from within rather than from the infrastructure.
Category 3: Non-configured products - This includes "software that is used as installed" and potentially "software that is configurable (category 4) but is used either unconfigured or with the standard defaults provided by the software supplier."
Category 4: Configured products - This includes products where "the user has the means and knowledge to change the functionality of the device in a way that changes the results outputted by the device. As a direct consequence, this triggers increased validation effort."
Category 5: Custom applications - This includes any "application, module, user-defined program, or macro" that has been written in-house or by a third party that "needs to be specified, version controlled, built, and tested (including integration testing with the commercial application, as applicable) as a minimum to ensure the quality of the software."
Other guides
As of April 2020, the ISPE has 13 guides, the latest published in May 2019, titled Data Integrity - Manufacturing Records.[11]
External links
- International Society for Pharmaceutical Engineering (ISPE) website
- GAMP 4 guide (PDF, archived)
- Overview of GAMP 5 guide
References
- ↑ "ISPE Glossary of Pharmaceutical and Biotechnology Terminology - Good Automated Manufacturing Practice (GAMP)". International Society for Pharmaceutical Engineering. https://ispe.org/glossary/g?title_contains=Good+Automated+Manufacturing+Practice&langcode=All. Retrieved 15 April 2020.
- ↑ 2.0 2.1 "GAMP 5: Are you up to date with the latest Validation Best Practices?". Dataworks Ltd. 15 October 2014. http://www.dataworks.ie/gamp-5-are-you-up-to-date-with-the-latest-validation-best-practices/. Retrieved 15 April 2020.
- ↑ Forrest, D. (1 September 2013). "What is GAMP and how did GAMP start?". Controlling Compliance Matters. Archived from the original on 09 February 2015. https://web.archive.org/web/20150209215737/http://www.controlling-compliance-matters.com/?p=190. Retrieved 15 April 2020.
- ↑ Smith, P. (1 December 2008). "20th Anniversary Special Feature: Validation and qualification". Pharmaceutical Technology Europe 20 (2). Archived from the original on 04 April 2015. https://web.archive.org/web/20150404050745/http://www.pharmtech.com/node/230212. Retrieved 15 April 2020.
- ↑ Maruccia, D. (21 March 2006). "GAMP Guideline & Validation Documentation" (PDF). Pharma Quality Europe. Archived from the original on 18 March 2015. https://web.archive.org/web/20150318190447/http://www.ssfa.it/allegati/GDL_GIQAR_GCP_GampGuidelineMilano06.pdf. Retrieved 15 April 2020.
- ↑ DeSpautz, J.; Kovacs, K.D.; Werling, G. (11 March 2008). "GAMP Standards For Validation Of Automated Systems". Pharmaceutical Processing. Archived from the original on 26 December 2010. https://web.archive.org/web/20101226195015/http://www.pharmpro.com/Articles/2008/03/GAMP-Standards-For-Validation-Of-Automated-Systems/. Retrieved 15 April 2020.
- ↑ 7.0 7.1 Wyn, S. (May/June 2018). "GAMP 5: Ten Years On". Pharmaceutical Engineering. https://ispe.org/pharmaceutical-engineering/may-june-2018/gamp-5-ten-years. Retrieved 15 April 2020.
- ↑ "GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems". International Society for Pharmaceutical Engineering. Archived from the original on 22 May 2017. https://web.archive.org/web/20170522232540/http://www.ispe.org/gamp5. Retrieved 15 April 2020.
- ↑ 9.0 9.1 John, J. (17 April 2013). "Overview of Computerized System Compliance Using the GAMP 5 Guide". ProPharma Group. https://www.slideshare.net/ProPharmaGroup/overview-of-computerized-systems-compliance-using-the-gamp-5-guide. Retrieved 15 April 2020.
- ↑ McDowall, R. D. (1 June 2009). "Understanding and Interpreting the New GAMP 5 Software Categories". SpectroscopyOnline.com. Advanstar Communications Inc. Archived from the original on 21 June 2015. https://web.archive.org/web/20150621071044/http://www.spectroscopyonline.com/understanding-and-interpreting-new-gamp-5-software-categories. Retrieved 15 April 2020.
- ↑ "Guidance Documents". International Society for Pharmaceutical Engineering. https://ispe.org/publications/guidance-documents. Retrieved 15 April 2020.
