cGMP and Regulatory Updates

1.0 OBJECTIVE : To lay down a procedure for Receiving, Issuing, controlling and allotting Reference number for HPLC and GC columns. 2.0 RESPONSIBILITY : 2.1 Officer-Analytical  Research & Development( AD) / Quality Control (QC) 2.2 Head - AD/QC to ensure compliance. 3.0 PROCEDURE 3.1 After receiving GRIR from Stores, Officer AD/QC shall check the HPLC and GC columns against the Purchase requisition ( Specifications). 3.2 The Officer AD/QC shall submit the GRIR with comments to Hea...

1.  Objective: To provide a standard cleaning procedure of  mass mixer  and its accessories. 2.  Scope: 2.1       This procedure covers dismantling and cleaning of mass mixer  and its accessories. 2.2       Provides cleaning procedure if the cleaning validity not exceed 48 hours 3.   Responsibility: ¯   Operator. ¯   Chemist. ¯   Production Manager. ¯   Q.A. Manager 4.   Procedure: 4.1       Switch off the main and close the material discharge hole . 4.2       Open the lid of themass mixer. Dismantle the propeller blade . 4.3       Wash the dismantled accessories with 0.5% (v/v) Teepol solution, 0.1 % Sodium Lauryl Sulphate by using nylon brush and finally rinse with DM water. 4.4       Fill raw water upto ¼ of the MM and wash with nylon brushes to remove powder of previous product...

1.     Objective: To provide standard cleaning procedure of  Fluidized bed drier and its accessories. 2.     Scope: 2.1       This procedure covers dismantling and cleaning of Fluidized bed drier and its accessories. 2.2       Provides cleaning procedure if the cleaning validity not exceed 48 hours. 3.     Responsibility: ¯   Operator. ¯   Chemist. ¯   Production Manager. ¯   Q.A. Manager. 4.   Procedure: 4.1       Switch off the main supply. 4.2       Dismantle the product chamber, Retard chamber, prefilter and finger bag strap. 4.3       Wash the fixed chamber & dismantled accessories with 0.5% (v/v) Teepol solution and product chamber should be washed with 0.1% Sodium Lauryl Sulphate by using nylon brush. Finally rinse with DM water. 4.4       Wipe whol...

1.     Objective: To provide standard cleaning procedure of Dry Syrup Filling & Sealing Machine & its accessories. 2.     Scope: 2.1       This procedure covers dismantling cleaning and assembling of Dry Syrup Filling & Sealing Machine and its accessories. 2.2       Provides cleaning procedure if the cleaning validity not exceed 48 hours. 3.     Responsibility: ¯   Operator. ¯   Chemist. ¯   Production Manager. ¯   Q.A.Manager. 4.     Procedure: 4.1       Wash all parts of the Dry Syrup Filling & Sealing machine with 0.5%v/v Teepol solution and rinse with DM water. 4.2       After that clean  the machine with dry cloth. 4.3       Collect the washed water and send it to Quality Assurance to check the presence of any residual moiety. 4.4   ...