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
Cleaning of Processing Cubicles or Areas 1.0 PURPOSE To define a procedure for cleaning the Product Processing Cubicles or Areas used for production, dispensing and storage activities. 2.0 SCOPE 2.1 This procedure applies for cleaning the Product Processing Cubicles or Areas used for production, dispensing and storage activities 3.0 REFERENCE 3.1 References … Read more
sop for Responsibilities of Quality Assurance 1.0 OBJECTIVE: To lay down a Procedure to define Role and Responsibilities of Quality Assurance Department. 2.0 SCOPE: This SOP is applicable to define the Role and Responsibilities of Quality Assurance Department 3.0 RESPONSIBILITY: QA Officer/ Executive 4.0 ACCOUNTABILITY: Head QA: Approval 5.0 PROCEDURE: 5.1 Responsibilities … Read more
sop of external audits at the site 1.0 OBJECTIVE: To lay down a Procedure for handling of external audits or inspections from Regulatory agency, Customer. 2.0 SCOPE: This SOP is applicable for handling of external audits or inspections from Regulatory agency, Customer 3.0 RESPONSIBILITY: 3.1 QA (Officer/ Executive): Preparation, Distribution (to Respective Departments), Revision, Retrieval … Read more
cip of mixing vessel and holding vessel 1.0 OBJECTIVE: To lay down the procedure for Cleaning of Mixing Vessel/Holding Vessel, Cartridge Housing and Filter Housings and Pipe lines using CIP. 2.0 SCOPE: This SOP is applicable to Cleaning of Mixing Vessel, Holding Vessel, Cartridge Housing and Filter Housings and Pipe Lines using CIP … Read more