cGMP and Regulatory Updates

1.0 PURPOSE: This SOP defines the procedure for preparing technical agreement with contract givers. 2.0 SCOPE: This SOP applies to the technical agreements made with contract givers for the manufacturing of pharmaceutical formulation by Alkem Laboratories Limited. 3.0 RESPONSIBILITY: 3.1 Head – Regulatory & corporate QA or his designee 3.1.1 Evaluating the technical agreement with the checklist. 3.1.2 Liaising with the contract giver for resolution of any technical issue. 4.0 ACCOUNTABILITY: Head- Corporate Quality Assurance (CQA) or his designee 5.0 PROCEDURE: 5.1 Purpose of Technical Agreement 5.1.1 A technical agreement clarifies the functional and technical aspects of a business relationship. It will delineate, in significant detail, the responsibilities of quality, regulatory, production, storage and distribution within each company. 5.1.2 The Technical Agreement will enhance the communication and build the confidence between the two parties and avoid conflicts a...