GAMP Requirements and Solutions
The Good Automated Manufacturing Practices (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.
Papers
|
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. |
|
GAMP® Good Practice Guide: Calibration Management Technical Document Review (145.9 KB) 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. |
|
Particle Counters for Pharmaceutical Cleanrooms (381.5 KB) This paper explains the various microcontamination requirements of pharmaceutical manufacturing, defines a clean manufacturing environment, and shows how to... Download above file for full tables and figures, or for overview, see HTML Version. |
|
Basic Guide to Particle Counters and Particle Monitoring (441.3 KB) 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. |
Products
PharmabilitiesLearn about our products, validation procedures, and system installations to help you achieve GAMP requirements. |
||
Pharmaceutical Particle Monitoring ServicesLearn about our services to help you meet GAMP . We can provide project management, compliance training, computer validation, facility monitoring validation, parenteral validation, pharmaceutical engineering, and training courses. Learn more now! |
Les informations sur ce site web peuvent être changées sans avis préalable.
