Common Contracts
1 similar Guidelines contracts
Therapeutic Goods Administration AustraliaGuidelines • December 3rd, 2015
Line 55 Good manufacturing practice for investigational medicinal products is set out in the Suggest adding abbreviation (GMP) Good manufacturing practice (GMP) for investigational medicinal products is set out in the Line 90 ‘This cooperation may be described in a technical agreement” ‘This cooperation should be described in a technical agreement as per Eudralex Vol 4, Chapter 7” (See also line 222) There should be some formal document where the CT sponsor has indicated the expectations/responsibilitiesrelating to manufacture. A QTA Lines 128-131 N/A "Deviations from any predefined specifications and instructions shall be investigated and corrective and preventive action (CAPA) measuresinitiated as appropriate." Added 'as appropriate', because CAPA may not always be required. Line 174 Physic-chemical Physico-chemical Typographical error Line 183 Specifications for starting materials, immediate packaging materials, intermediate products, bulk products and finished products, manufacturi
