"The equipment acquisition model is a process flow of the activities that occur for an equipment purchase that must be qualified/validated," explains Jim John, Chairman and one of the JETT consortium's founders.
The team alternates bimonthly in-person meetings among several of the participating member companies. Web-based meetings are held on the months between in-person meetings to make it more practical for more participants. Waunetka A. Clark, principal quality engineer, global pharmaceutical operations, served as Abbott Laboratories' host at the January meeting.
"A better understanding of the process helps in the project management and has an impact on what is needed and why," says John, consultant with the ProPharma Group. "Packaging engineers can lay this out with the suppliers and consultants to make sure everyone understands the road map. The intent is to provide a big-picture view for use with project teams from the user and the supplier communities to help them better understand where the pieces fit."
JETT is under the ISPE (International Society for Pharmaceutical Engineering)'s GAMP (Good Automated Manufacturing Practice) Community of Practice. JETT's members are primarily from the pharmaceutical market, although it also has representation from biotech and medical device companies.
"Our mission is to improve the process of validating automated equipment for the Food and Drug Administration-regulated industries through working with vendors, consultants, and end-user companies," says John. He says that 40% of JETT's 164 total members are from end-user firms, 30% from suppliers, while 30% represent consultantcies. Eli-Lilly, Pfizer, and Medpointe Pharmaceuticals are among JETT's end-user company members.
The team alternates bimonthly in-person meetings among several of the participating member companies. Web-based meetings are held on the months between in-person meetings to make it more practical for more participants. Waunetka A. Clark, principal quality engineer, global pharmaceutical operations, served as Abbott Laboratories' host at the January meeting.
"A better understanding of the process helps in the project management and has an impact on what is needed and why," says John, consultant with the ProPharma Group. "Packaging engineers can lay this out with the suppliers and consultants to make sure everyone understands the road map. The intent is to provide a big-picture view for use with project teams from the user and the supplier communities to help them better understand where the pieces fit."
JETT is under the ISPE (International Society for Pharmaceutical Engineering)'s GAMP (Good Automated Manufacturing Practice) Community of Practice. JETT's members are primarily from the pharmaceutical market, although it also has representation from biotech and medical device companies.
"Our mission is to improve the process of validating automated equipment for the Food and Drug Administration-regulated industries through working with vendors, consultants, and end-user companies," says John. He says that 40% of JETT's 164 total members are from end-user firms, 30% from suppliers, while 30% represent consultantcies. Eli-Lilly, Pfizer, and Medpointe Pharmaceuticals are among JETT's end-user company members.
