dqa - r&d in poanta sahib

1\. - Preparation, Review and Approval of Guidelines for Product Developmentand Analytical Development. 2\. - Review and Approval of Formulation Development Documents.  Product Development Report  Master Formula Record  Batch Manufacturing Record  Stability Protocols and Data  Packaging Development Report  Master Packaging Record  Technology Transfer Protocol / Report (Scale up and Exhibit Batches) 3\. - Review and Approval of Analytical Development Documents.  Analytical Method Development Report  Specification and Method of Analysis  Analytical Method Validation Protocol / Report  Certificate of Analysis and Data4\. -Handling of Quality Management System in RnD  Change Control Management  Deviation Management  Laboratory Incident Management  Vendor Qualification  Equipment Qualification  Internal Audit  Good Documentation Practices  Training5\. - Document Management System - Document issuance, Document Distribution,Document Retrieval, Document Destruction, Document Retention. -Thorough knowledge of guidelines e.g WHO, ICH, EU and India. Standard operating procedures review and implementation for RnD.

development quality assurance, DQA