1.0 PURPOSE
To lay down the procedure for appointing a consultant.
2.0 SCOPE
2.1 This procedure is applicable in Quality Assurance Department.
3.0 RESPONSIBILITY
3.1 Manager – Quality Assurance
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance
5.0 PROCEDURE
5.1 The consultant shall be appointed on following but not limited to
• Advice and guidance on the manufacture and control of intermediate or API.
• Consultancy for project activities, regulatory approvals such as USFDA, MCA, MCC.
• Consultancy for safety, health and environment (S,H,E)
5.2 The consultant shall be enrolled on Consultant Enrollment Form as format given in Annexure-I against the proposed project proposal submitted.
5.3 Project proposal shall consist minimum but not limited of the following.
5.3.1 Detailed objective and scope of project
5.3.2 Conceptual, engineering, technical and commercial out look and requirement on project.
5.3.3 Regulatory periphery, which is going to cover under this project preview.
5.3.4 Detail schematic or engineering diagram as per need shall be part of project.
5.3.5 Commercial implication of project
5.4 The Capability and approval of consultant shall be on following by validation core committee.
5.4.1 Technical and practical viability of project
5.4.2 Academic and qualification enforcement of project
5.4.3 Resource management viability
5.4.4 Regulatory compliance status of project
5.4.5 Time frame and commercial implication of project
5.5 Written contact or work order shall release to complete the relevant task after finalizing the consultant.
5.6 The scope of the contract shall be clearly mentioned in the relevant work order/contract.
END OF DOCUMENT
Appointing consultant, quality assurance, proposal submitted
