ICH Q7A definition
Examples of ICH Q7A in a sentence
The API supplier selection, certification and verification of GMP compliance (ICH Q7A) are the responsibility of CUSTOMER.
Shasun shall assure that all systems used to manufacture, test, release, and distribute the Product shall comply with ICH Q7A section 12 Validation, as well as additional in-house requirements.
FDA and ICH guidelines provide that a sponsor seeking a license is considered the “manufacturer” even if they use a contract manufacturing organization, and the sponsor is responsible for ensuring GMP compliance for those activities that have been contracted out (US FDA 21 CFR 600.3(t), ICH Q7A Section 2).
This audit will include a review of PDL’s PQ Plans and Reports, and their overall Quality Management System, using the standards set forth in ICH Q7A and the US and EMEA Regulations.
All manufacture and supply of API will be performed in accordance with current Good Manufacturing Practices and the International Conference on Harmonization (ICH) Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
NEKTAR AL hereby warrants and represents that all SELECTED REAGENTS purchased by COMPANY from NEKTAR AL under this AGREEMENT shall conform to the SPECIFICATIONS when delivered to COMPANY and will have been manufactured for and delivered to COMPANY in accordance with applicable laws, rules and regulations, and except for SELECTED REAGENTS to be used for preclinical use, consistent with ICH Q7A.
In performance of this Agreement, each party shall comply with all laws, regulations, rules, orders and other requirements and guidelines (e.g., record retention provisions of ICH Q7A guidelines), now or hereafter in effect, and governmental authorities having jurisdiction.
Any terms not defined in this Quality Agreement will be interpreted in accordance with the definitions provided in ICH Q7A GMP Guidance for Active Pharmaceutical Ingredients, 21 CFR, Parts 210 and 211, or other applicable regulatory requirements.
Throughout the Term, and for so long thereafter as is required by Applicable Law, each Party shall monitor and maintain reasonable records respecting its compliance with GMP for Finished Product (in the case of MIOL) and ICH Q7A (in the case of Oscient), including through the establishment and implementation of such operating procedures as are reasonably necessary to assure such compliance.
This quality agreement, (written in accordance with the principles defined in Section 16 of the ICH Q7A Guideline “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”), specifies the relationship between NTP Radioisotopes (Pty) Ltd., Pelindaba, Pretoria, South Africa and Lantheus Medical Imaging Company, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇., ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ▇▇▇ for the final materials, listed in Appendix A.