PRODUCTION SYSTEMS Clause Samples
PRODUCTION SYSTEMS. 9.1 Manufacture of Products will be done at WuXi’s pharmaceutical manufacturing facilities on a campaign basis, using procedures for manufacturing and control of Products set forth in Master Batch Records according to Process Descriptions approved by ZMC.
PRODUCTION SYSTEMS. Manufacture of clinical batches of Product will be done at BIP’s pharmaceutical manufacturing facility and will occur on a campaign basis. BIP will use procedures for manufacturing and control of Product set forth in the Master Batch Records according to Process Descriptions approved by CLIENT. BIP’s Quality Assurance organisation will review the completed documentation and confirm that all activities were carried out in accordance with Process instructions and cGMPs.
PRODUCTION SYSTEMS. 20,25 Products.....................................................................33 Release......................................................................29 ROCS Acquisition, Inc.........................................................1
PRODUCTION SYSTEMS. If ordered by the Government, the contractor shall deliver up to 250 production systems after a successful Production Approval decision.
PRODUCTION SYSTEMS. Vendor and its Subcontractors shall require all hardware and software Systems that support the Program (“Production Systems”) to follow, at a minimum, all standard protocols and security compliance guidelines defined by the International Organization of Standardization.
a. Production Data shall not leave, or be Accessed or maintained from outside, the continental U.S;
b. Vendor and its Subcontractors may perform Services and/or Access Production Data from outside of the State of Florida but within the continental U.S. for purposes of
(i) implementing or testing the disaster recovery plan, (ii) providing desktop support services, or (iii) providing/receiving occasional and limited consulting assistance to or from a company affiliated with Vendor;
c. Members of the LSAG may perform Services and/or Access Production Data from outside Vendor’s Florida CEC(s) but within the continental U.S. Such persons may also, on a limited basis, Access Production Data from outside of the continental U.S. in order to provide emergency production support Services so long as FHKC consents to such Access in advance or is advised within one Business Day after such Access;
d. Persons in the LSAG must be pre-approved by FHKC, which approval shall not be unreasonably withheld. FHKC shall promptly review each request and either state its objections or request more information. Vendor shall advise FHKC’s Contract Manager of any changes in the LSAG and annually provide FHKC with an updated LSAG Master Listing as required in Appendix A;
e. Vendor may use Oracle and other third-party software or hardware vendors to provide certain IT services from outside the State of Florida and outside the continental U.S. to support those who provide Services under this Contract. In the course of providing such emergency services, these third-party vendors may Access Production Data but shall not have direct access to the CRM System. Vendor shall use reasonable efforts to obtain FHKC’s written consent prior to giving such Access to these third-party vendors and shall advise FHKC within one Business Day after such Access;
f. Employees of Vendor (other than CSRs) may use their business laptop computers to Access Production Data by reading, replying, forwarding, having or using electronic mail, or otherwise utilizing the electronic mail System, on a temporary, limited basis when traveling outside the State of Florida and/or outside the continental U.S. so long as
(i) the employee has a legitimate busine...
PRODUCTION SYSTEMS