GMPI definition
Examples of GMPI in a sentence
Other information on the quality of the medical devices, as defined in the GMP-I Article 4, Paragraph 1, Number 3.
The Parties will collaborate in such reporting which occurs in relation to LdT Drug Product in accordance with pharmacovigilance arrangements and procedures to be separately agreed by the Parties which arrangements and procedures are designed to facilitate compliance by each Party with applicable Pharmaceutical Laws, ICH harmonized guidelines, GMPI guidelines and other applicable regulations.
The GMPI agreement shall be otherwise discussed and signed by both parties, but it is expressly agreed and understood that the terms of this Agreement shall supercede and be controlling over any conflicting or contrary terms found in the GMPI Agreement.
Nippon EUROTEC warrants that the procedures herein comply with GMP-I regulations, and indemnifies and holds Natus harmless from any liability arising from any action by Nippon EUROTEC with respect to such GMP-I laws, regulations, or procedures, it being expressly understood that such GMP-I laws, regulations, or procedures are Japanese domestic laws, the responsibility for compliance of which rests with Nippon EUROTEC, as Natus' exclusive distributor.
To the extent applicable, the Parties will comply with GMPI guidelines in connection with any change to the manufacturing conditions or Specifications either Party may request.
Nippon Eurotec shall request from Natus prompt transmission of information regarding changes to be made to future manufacturing methods, testing methods or other related issues which may have possible effects on the quality of the medical devices, as defined in the GMP-I Article 4, Paragraph 1, Number 2.
Nippon Eurotec desires to smoothly communicate with Natus in order to obtain such information from Natus as is required by the new Japanese Regulations for Quality Assurance of Imported Medical Device, or Good Manufacturing Practice - Import regulations ("GMP-I").
Nippon Eurotec shall send every year, at Nippon EUROTEC's expense, an inspector to Natus' manufacturing site for GMP-I inspection.
MacroPore also shall inform ▇▇▇▇▇ of any matters required so that ▇▇▇▇▇ will be able to observe the Good Manufacturing Practice for Import (GMPI) imposed in the Territory.
January 1, 2000 GMP-I AGREEMENT This GMP-I Agreement ("Agreement"), effective as of January 1, 2000 (the "Effective Date") is entered into by and between Natus Medical Inc., a California corporation having offices at ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇ ("Natus"), and Nippon Eurotec Co., Ltd.