PREPARATION, APPROVAL, REVIEW AND CONTROL OF TECHNICAL DIRECTIONS FOR MANUFACTURE OF PHARMACEUTICAL PRODUCTS

Description

Technical Directions; Document, which reveals all approved instructions regarding manufacturing of the product starting from dispensing of raw materials, packaging materials, manufacturing and packaging operations including in-process checks and final dispatch for distribution, to get an appropriate quality of finished product. This document shall comprise of two separate parts- Technical Directions detailing Manufacturing procedure and  Technical Directions detailing Packaging procedure. Technical Directions shall always be a part of BMR and shall be prepared with a provision of recordings, which shall be done during manufacture of a product by the competent Production and Quality staff.