Records and Regulatory Matters. 9 6.1 Permits 9 6.2 Compliance with cGMP 9 6.3 Access to Records 9 6.4 Record Maintenance 10 6.5 Accurate Documentation 10 6.6 Claims and Complaints 10 6.7 Regulatory Communications and Correspondence 10 6.8 New Regulatory Requirements 10 6.9 Manufacturing Records and Maintenance 10 6.10 Cooperation in Obtaining Government Approvals 10 6.11 Ownership of Regulatory Filings 10 6.12 Safety and Efficacy Claims 11 6.13 Accident Reports 11
Appears in 3 contracts
Sources: Topical Interferon Alpha 2b GMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp), GMP Process Development and Manufacturing Agreement (Helix BioPharma Corp), Topical Interferon Alpha 2b GMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp)