Good Automated Manufacturing Practice - Revision history

Shawndouglas: /* References */ Cat

2022-09-20T15:14:21Z

References: Cat

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	<!---Place all category tags here-->		<!---Place all category tags here-->
			[[Category:Manufacturing and R&D industry]]
	[[Category:Production standards]]		[[Category:Production standards]]

Shawndouglas: Updated URLs for 2022

2022-01-07T22:44:42Z

Updated URLs for 2022

← Older revision		Revision as of 22:44, 7 January 2022
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	==External links==		==External links==

	* [~~http~~://~~www.~~ispe.org International Society for Pharmaceutical Engineering (ISPE) website]		* [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)
	* [~~http~~://www.slideshare.net/ProPharmaGroup/overview-of-computerized-systems-compliance-using-the-gamp-5-guide GAMP 5 guide]		* [https://www.slideshare.net/ProPharmaGroup/overview-of-computerized-systems-compliance-using-the-gamp-5-guide Overview of GAMP 5 guide]

	==References==		==References==

Shawndouglas: Added review history

2020-04-15T21:06:17Z

Added review history

← Older revision		Revision as of 21:06, 15 April 2020
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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=~~http~~://~~www.~~ispe.org/glossary?~~term~~=Good+Automated+Manufacturing+Practice~~+%28GAMP%29~~ \|title=ISPE Glossary of Pharmaceutical and Biotechnology Terminology - Good Automated Manufacturing Practice (GAMP) \|publisher=International Society for Pharmaceutical Engineering ~~\|date=25 September 2011~~ \|accessdate=~~28 February 2012~~}}</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.		'''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/~~blog~~/~~are_you_up_to_date_with_the_latest_validation_best_practices_read_about_gam~~ \|title=GAMP 5: Are you up to date with the latest Validation Best Practices? \|publisher=Dataworks Ltd \|date=15 October 2014 \|accessdate=~~10 February 2015~~}}</ref>:		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, ~~David~~ \|work=Controlling Compliance Matters \|date=01 September 2013 \|~~accessdate~~=09 February 2015}}</ref>		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 [[Good Manufacturing Practice]] (GMP) compliance of manufacturing and related systems.<ref name="Smith20th">{{cite journal \|url=http://www.pharmtech.com/~~pharmtech~~/~~Validation~~/~~20th-Anniversary-Special-Feature-Validation-and-qu~~/~~ArticleStandard~~/~~Article~~/~~detail~~/~~574642~~ \|title=20th Anniversary Special Feature: Validation and qualification \|journal=Pharmaceutical Technology Europe \|volume=20 \|issue=2 \|author=Smith, ~~Paul~~ \|date=1 December 2008 \|accessdate=~~28 February 2012~~}}</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 \|format=PDF \|title=GAMP Guideline & Validation Documentation \|author=Maruccia, ~~Danilo~~ \|publisher=Pharma Quality Europe \|date=21 March 2006 \|accessdate=~~09 February 2015~~}}</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/ \|title=GAMP Standards For Validation Of Automated Systems \| author=DeSpautz, ~~Joseph~~; ~~Kenneth S~~. ~~Kovacs~~; ~~Gerhard~~ Werling \|~~publisher~~=Pharmaceutical Processing \|date=11 March 2008 \|accessdate=~~28 February 2012~~}}</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 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=~~28 February 2012~~}}</ref>		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=~~http~~://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, ~~Jim~~ \|publisher=ProPharma Group \|date=17 April 2013 \|accessdate=~~09 February 2015~~}}</ref>:		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.
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	====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. ('''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 \|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=~~10 February 2015~~}}</ref>:

	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.
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	===Other guides===		===Other guides===
	As of ~~February 2015~~, the ISPE has 13 guides, the latest published in ~~October 2014~~, titled ''~~A Risk~~-~~Based Approach to Regulated Mobile Applications~~''.<ref name="GAMPPubs">{{cite web \|url=~~http~~://~~www.~~ispe.org/~~gamp~~-~~good-practice-guides~~ \|title=~~GAMP Good Practice Guides~~ \|publisher=International Society for Pharmaceutical Engineering \|accessdate=~~09 February 2015~~}}</ref>		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==
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	==References==		==References==
	~~<references/>~~		{{Reflist\|colwidth=30em}}

	<!---Place all category tags here-->		<!---Place all category tags here-->
	[[Category:Production standards]]		[[Category:Production standards]]

Shawndouglas: /* System categorization */ Actually, I made a mistake. Corrected and moved note to better location.

2016-03-25T17:22:00Z

System categorization: Actually, I made a mistake. Corrected and moved note to better location.

← Older revision		Revision as of 17:22, 25 March 2016
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	====System categorization====		====System categorization====

	Software systems borne from these principles can be categorized into one of ~~five~~ 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=10 February 2015}}</ref>:		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 \|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=10 February 2015}}</ref>:

	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.
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	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."

	~~'''Note''': "Category 2: Firmware" was removed from GAMP with revision five.~~

	===Other guides===		===Other guides===

Shawndouglas: /* System categorization */ Corrected typo

2016-03-25T17:21:02Z

System categorization: Corrected typo

← Older revision		Revision as of 17:21, 25 March 2016
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	====System categorization====		====System categorization====

	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=10 February 2015}}</ref>:		Software systems borne from these principles can be categorized into one of five 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=10 February 2015}}</ref>:

	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.

Shawndouglas: Moved cat.

2015-04-11T16:08:10Z

Moved cat.

← Older revision		Revision as of 16:08, 11 April 2015
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	[[Category:~~Regulatory information~~]]		[[Category:Production standards]]

Shawndouglas: Added image.

2015-02-17T17:42:59Z

Added image.

← Older revision		Revision as of 17:42, 17 February 2015
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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.]]
	'''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=http://www.ispe.org/glossary?term=Good+Automated+Manufacturing+Practice+%28GAMP%29 \|title=ISPE Glossary of Pharmaceutical and Biotechnology Terminology - Good Automated Manufacturing Practice (GAMP) \|publisher=International Society for Pharmaceutical Engineering \|date=25 September 2011 \|accessdate=28 February 2012}}</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.		'''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=http://www.ispe.org/glossary?term=Good+Automated+Manufacturing+Practice+%28GAMP%29 \|title=ISPE Glossary of Pharmaceutical and Biotechnology Terminology - Good Automated Manufacturing Practice (GAMP) \|publisher=International Society for Pharmaceutical Engineering \|date=25 September 2011 \|accessdate=28 February 2012}}</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.

Shawndouglas: Added more content.

2015-02-10T17:53:30Z

Added more content.

← Older revision		Revision as of 17:53, 10 February 2015
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	'''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=http://www.ispe.org/glossary?term=Good+Automated+Manufacturing+Practice+%28GAMP%29 \|title=ISPE Glossary of Pharmaceutical and Biotechnology Terminology - Good Automated Manufacturing Practice (GAMP) \|publisher=International Society for Pharmaceutical Engineering \|date=25 September 2011 \|accessdate=28 February 2012}}</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. ~~Standard operating procedures (SOPs)~~ are ~~essential~~ for ~~processes that can affect~~ the ~~quality~~ of the ~~finished product~~.		'''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=http://www.ispe.org/glossary?term=Good+Automated+Manufacturing+Practice+%28GAMP%29 \|title=ISPE Glossary of Pharmaceutical and Biotechnology Terminology - Good Automated Manufacturing Practice (GAMP) \|publisher=International Society for Pharmaceutical Engineering \|date=25 September 2011 \|accessdate=28 February 2012}}</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/blog/are_you_up_to_date_with_the_latest_validation_best_practices_read_about_gam \|title=GAMP 5: Are you up to date with the latest Validation Best Practices? \|publisher=Dataworks Ltd \|date=15 October 2014 \|accessdate=10 February 2015}}</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>

	==History==		==History==
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	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=28 February 2012}}</ref>		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=28 February 2012}}</ref>

	The ~~documentation surrounding GAMP 5 is described by the ISPE and researcher Jim John as follows~~<ref name="JohnsPre">{{cite web \|url=http://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, Jim \|publisher=ProPharma Group \|date=17 April 2013 \|accessdate=09 February 2015}}</ref>:		The guidance generally states that pharmaceutical computer systems should be built with several key ideas in mind<ref name="JohnsPre">{{cite web \|url=http://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, Jim \|publisher=ProPharma Group \|date=17 April 2013 \|accessdate=09 February 2015}}</ref>:

	* GAMP 5 guiding principles and framework;
	* appendices on general, management, developmental, operational, and special interest features of the guidance;
	* good practice guides on aspects such as laboratories, testing, process control, and electronic records management among others; and
	* additional templates, training materials, and articles on GAMP.

	~~The guidance generally states that pharmaceutical computer systems should be built with several key ideas in mind<ref name="JohnsPre" /~~>:

	1. Make product and process understanding clear.		1. Make product and process understanding clear.
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	5. Leverage supplier involvement into the system.		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. 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=10 February 2015}}</ref>:

			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."

			'''Note''': "Category 2: Firmware" was removed from GAMP with revision five.

	===Other guides===		===Other guides===

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	1. Make product and process understanding clear.		1. Make product and process understanding clear.

	2. Approach the life cycle from the standpoint of a quality management system.		2. Approach the life cycle from the standpoint of a quality management system.

	3. Make life cycle activities scalable.		3. Make life cycle activities scalable.

	4. Ensure quality risk management is science-based.		4. Ensure quality risk management is science-based.

	5. Leverage supplier involvement into the system.		5. Leverage supplier involvement into the system.

Shawndouglas: Added content.

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	==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, David \|work=Controlling Compliance Matters \|date=01 September 2013 \|accessdate=09 February 2015}}</ref>

	GAMP itself was founded in 1991 in the ~~United Kingdom~~ 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/pharmtech/Validation/20th-Anniversary-Special-Feature-Validation-and-qu/ArticleStandard/Article/detail/574642 \|title=20th Anniversary Special Feature: Validation and qualification \|journal=Pharmaceutical Technology Europe \|volume=20 \|issue=2 \|author=Smith, Paul \|date=1 December 2008 \|accessdate=28 February 2012}}</ref> GAMP published its first guidance in 1994. Soon afterwards the organization entered into a partnership with ISPE, formally becoming part of ISPE in 2000. 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/ \|title=GAMP Standards For Validation Of Automated Systems \| author=DeSpautz, Joseph; Kenneth S. Kovacs; Gerhard Werling \|publisher=Pharmaceutical Processing \|date=11 March 2008 \|accessdate=28 February 2012}}</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 [[Good Manufacturing Practice]] (GMP) compliance of manufacturing and related systems.<ref name="Smith20th">{{cite journal \|url=http://www.pharmtech.com/pharmtech/Validation/20th-Anniversary-Special-Feature-Validation-and-qu/ArticleStandard/Article/detail/574642 \|title=20th Anniversary Special Feature: Validation and qualification \|journal=Pharmaceutical Technology Europe \|volume=20 \|issue=2 \|author=Smith, Paul \|date=1 December 2008 \|accessdate=28 February 2012}}</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 \|format=PDF \|title=GAMP Guideline & Validation Documentation \|author=Maruccia, Danilo \|publisher=Pharma Quality Europe \|date=21 March 2006 \|accessdate=09 February 2015}}</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/ \|title=GAMP Standards For Validation Of Automated Systems \| author=DeSpautz, Joseph; Kenneth S. Kovacs; Gerhard Werling \|publisher=Pharmaceutical Processing \|date=11 March 2008 \|accessdate=28 February 2012}}</ref>

	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>{{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=28 February 2012}}</ref>		==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.<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=28 February 2012}}</ref>

			The documentation surrounding GAMP 5 is described by the ISPE and researcher Jim John as follows<ref name="JohnsPre">{{cite web \|url=http://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, Jim \|publisher=ProPharma Group \|date=17 April 2013 \|accessdate=09 February 2015}}</ref>:

			* GAMP 5 guiding principles and framework;
			* appendices on general, management, developmental, operational, and special interest features of the guidance;
			* good practice guides on aspects such as laboratories, testing, process control, and electronic records management among others; and
			* additional templates, training materials, and articles on GAMP.

			The guidance generally states that pharmaceutical computer systems should be built with several key ideas in mind<ref name="JohnsPre" />:

			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.

			===Other guides===
			As of February 2015, the ISPE has 13 guides, the latest published in October 2014, titled ''A Risk-Based Approach to Regulated Mobile Applications''.<ref name="GAMPPubs">{{cite web \|url=http://www.ispe.org/gamp-good-practice-guides \|title=GAMP Good Practice Guides \|publisher=International Society for Pharmaceutical Engineering \|accessdate=09 February 2015}}</ref>

	==External links==		==External links==

	* [http://www.ispe.org International Society for Pharmaceutical Engineering (ISPE) website]		* [http://www.ispe.org International Society for Pharmaceutical Engineering (ISPE) website]
			* [http://www.ssfa.it/allegati/GDL_GIQAR_GCP_GampGuidelineMilano06.pdf GAMP 4 guide] (PDF)
			* [http://www.slideshare.net/ProPharmaGroup/overview-of-computerized-systems-compliance-using-the-gamp-5-guide GAMP 5 guide]

	==References==		==References==