sop of control and distribution of signature log 1.0 OBJECTIVE : 1.1 To lay down a procedure for preparation, control and distribution of signature log so as to identify the persons who has acknowledged the documents/record. 2.0. SCOPE : 2.1 This procedure is applicable to all employees who are responsible for … Read more
sop for Preparation of validation master plan 1.0 OBJECTIVE : 1.1 To lay down a procedure for preparation of validation master plan. 2.0 SCOPE : 2.1 This procedure is applicable for preparation of validation master plan. 3.0 RESPONSIBILITY : 3.1 Officer / Executive QA or designee shall be responsible for: 3.1.1 Preparation, Controlling, … Read more
Sop for Procedure for Vendor Qualification 1.0 OBJECTIVE : To establish procedure for evaluation, approval and disqualification of vendors for procurement of raw materials and packaging materials required for manufacturing and packing of finished products respectively. 2.0. SCOPE : 2.1 This procedure is applicable to all written or oral market complaints (regarding … Read more
Online Rejection in parenteral 1.0 OBJECTIVE: 1.1 To lay down the Procedure for Online Rejection in parenteral 2.0 SCOPE: 2.1 This SOP is applicable for Online Rejection at area 3.0 RESPONSIBILITY: 3.1 Officer / Executive – Concerned Department 4.0 ACCOUNTABILITY: 4.1 Head – Production 5.0 PROCEDURE: 5.1 Officer /Supervisor of concerned department shall … Read more
Cleaning and Filling of Isopropyl Alcohol Bottles 1.0 OBJECTIVE: 1.1 To lay down a procedure for Cleaning and Filling of Isopropyl Alcohol Bottles. 2.0 SCOPE: 2.1 This SOP is applicable for Cleaning and Filling of Isopropyl Alcohol Bottles used in Injection Parenteral Area 3.0 RESPONSIBILITY: 3.1 Officer / Executive – Production 4.0 ACCOUNTABILITY: … Read more
sop for for Cleaning and Sterilization of Goggles 1.0 OBJECTIVE: 1.1 To lay down the procedure for Cleaning and Sterilization of Goggles. 2.0 SCOPE: 2.1 This SOP is applicable to Cleaning and Sterilization of Goggles in Injection (Parenteral) Area 3.0 RESPONSIBILITY: 3.1 Officer / Executive – Production 4.0 ACCOUNTABILITY: 4.1 Head – Production … Read more
sop for for Spillage Handling in parenteral area 1.0 OBJECTIVE: 1.1 To lay down the procedure for Spillage Handling. 2.0 SCOPE: 2.1 This SOP is applicable for Handling of Spillage of all Substances and Products in Injection (Parenteral) Area 3.0 RESPONSIBILITY: 3.1 Officer / Executive – Production 4.0 ACCOUNTABILITY: 4.1 Head – Production … Read more
sop for calibration of vessels with dipstick 1.0 OBJECTIVE: 1.1 To lay down a Procedure for calibration of vessels with dipstick. 2.0 SCOPE: 2.1 This SOP is applicable to calibration of vessels with dipstick in Injection Parenteral Departments 3.0 RESPONSIBILITY: 3.1 Officer /Executive Production 3.2 Officer /Executive QA 4.0 ACCOUNTABILITY: 4.1 Head Production … Read more
sop for Cleaning of Bins and Containers 1.0 OBJECTIVE: 1.1 To lay down a Procedure for Cleaning of Bins and Containers. 2.0 SCOPE: 2.1 This SOP is applicable for Cleaning of Bins and Containers in Injection 3.0 RESPONSIBILITY: 3.1 Officer / Executive Production 4.0 ACCOUNTABILITY: 4.1 Head – Production 5.0 PROCEDURE: 5.1 Transfer … Read more
sop for Event Reporting and Investigation 1. Purpose: To define procedure for event reporting and investigation. 2. Scope: This SOP is applicable to all events which can affect the Safety, Identity, Strength, Purity and or Quality of the product which can be, 2.1 Facility related. 2.2 Utility/Service related. 2.3 Storage … Read more