What is Good Automated Manufacturing Practice GAMP?

The Good Automated Manufacturing Practice GAMP is a group of guidelines to perform implementations and validations following the System Development Life Cycle SDLC..  It was created by ISPE to address FDA and other regulatory agency expectations for computerized system compliance and validation. In addition, the GAMP^® Good Automated Manufacturing Practice GAMP is recognized globally by regulated companies and their suppliers and are widely supported by regulatory agencies.

For example, the GAMP^® 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advances.

GAMP® guidance aims to achieve computerized systems that are fit for the intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.

GAMP Good Practice Guides are a series of documents providing practical guidance on the implementation of different applications in the industry.

This guidance may be applied to both new and existing GxP regulated computerized systems.

The GAMP Good Practice Guides available at the time of publication of this article are:

Good Practice Guide Title Publication: Good Automated Manufacturing Practice GAMP

GAMP Good Practice Guide: Calibration Management 2001

GAMP Good Practice Guide: Validation of Process Control Systems 2003

GAMP Good Practice Guide: The Validation of Legacy Systems 2003

GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures 2005

GAMP Good Practice Guide: Validation of Laboratory Computerized Systems 2005

GAMP Good Practice Guide: IT Infrastructure Control and Compliance 2005

GAMP Good Practice Guide: Global Information Systems Control and Compliance 2005

GAMP Good Practice Guide: Testing of GxP Systems 2005

GAMP Good Practice Guide: Electronic Data Archiving 2007

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For more details on specific FDA expectations and how to perform a Computer System Validation SDLC, follow us.

Three (3) Options to Create a Computer System Validation Protocol following the Good Automated Manufacturing Practice GAMP:

Option 1. You Can Create CSV Protocol, using a Template.

You can download samples of the validation templates in .pdf format. 

To see the complete list of the most popular validation templates, click here.

In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill and adapt to your needs.

Option 2. We Can Bring You a Formal Training on the Systems Development Life Cycle.

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We Can Create Customized Test Scripts and Computer System Validation Protocol.

One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.

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REFERENCES: Good Automated Manufacturing Practice GAMP and others

httpss://www.fda.gov/media/73141/download

Food and Drug Administration References

1. Glossary of Computerized System and Software Development Terminology (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, FDA 1995)
2. General Principles of Software Validation; Final Guidance for Industry and FDA Staff (FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, 2002)
3. Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices (FDA, Center for Devices and Radiological Health, 1999)
4. Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems ApproachExternal Link Disclaimer (FDA 2002)
5. httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
6. httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1

Industry References: Good Automated Manufacturing Practice GAMP and others

1. The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) (https://www.ispe.org/gamp/)
2. ISO/IEC 17799:2000 (BS 7799:2000) Information technology – Code of practice for information security management (ISO/IEC, 2000)
3. ISO 14971:2002 Medical Devices- Application of risk management to medical devices (ISO, 2001)