[change country]- 21 CFR 1271 for Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P)
- 21 CFR Part 11 Compliance
- Airborne Particle Counters
- DI Water / UPW Particle Monitoring
- GAMP® Requirements and Solutions
- GMP and cGMP Particle Counting Requirements for EU and FDA Regulations
- ISO 14644 Cleanroom Classes for Particle Monitoring
- ISO 21501: Determination of Particle Size Distribution
single particle light interaction methods - ISO Cleanroom Class Particle Monitoring
- ITRS Roadmap Solutions
- Microbial
- Monitoring Particles in Injectables for USP 788 and EP6
- NEW INFORMATION GUIDES
- NEW INFORMATION GUIDES
- Optical Haze Blurs the Bottom Line
- Particle Counters for Gas Applications
- USP 797 Particle Monitoring Solutions
- WET PROCESS CONTROL
- processcontrols
GAMP® Requirements and Solutions
The Good Automated Manufacturing Practice (GAMP®) guide is a definitive methodology for the validation of computer and PLC controlled processes. Originally a supplier's guide for companies wanting to show engineering control over processes integrated into a pharmaceutical manufacturing environment, it has developed into a user and supplier guide for the specification and operation of systems. Particle Measuring Systems has been supplying pharmaceutical environmental monitoring systems to GAMP® standards for over 15 years, below are white papers and examples of the validation requirements for automated monitoring.
For specific questions on GAMP® or other pharmaceutical issues, please contact Mark Hallworth at mhallworth@pmeasuring.com or 303.443.7100.
GAMP® is a registered trademark of ISPE. To learn more about GAMP to place an order, visit www.ispe.org.
Papers
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This review document has been approved by the ISPE. To learn more about GAMP or to place an order, visit www.ispe.org Download above file for full tables and figures, or for overview, see HTML Version. |
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This paper explains the various microcontamination requirements of pharmaceutical manufacturing, defines a clean manufacturing environment, and shows how to certify a cleanroom. Special examples of a sterilizing tunnel and lyophilizer are included. Learn more now... Download above file for full tables and figures, or for overview, see HTML Version. |
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Click here to signup and download files (Basic Guide to Particle Counters and Particle Counting) This overview of particle contamination starts by discussing sources of contamination and monitoring technologies available, and continues by discussing various... Download above file for full tables and figures, or for overview, see HTML Version. |
Information on this website is subject to change without notice.
