sop for sampling of sterile raw material 1.0 OBJECTIVE To lay down a procedure for aseptic sampling of sterile Raw Material so as to get a Representative sample of the whole lot for analysis. 2.0 RESPONSIBILITY Quality Control Officer. 3.0 ACCOUNTABILITY Quality Control Manager. 4.0 PROCEDURE 4.1 Generate Sampler’s checklist-RM as per the … Read more
sop for sampling of intermediates and finished products 1.0 OBJECTIVE: The objective of this SOP is: 1.1 To describe the procedure for sampling of intermediates and finished products during manufacturing operations. 2.0 RESPONSIBILITIES: 2.1 Quality Assurance Officer / Executive shall be: 2.1.1 Responsible for withdrawal of samples of Intermediates and Finished products on … Read more
sop for operation and calibration of friability test apparatus 1.0 OBJECTIVE To lay down the procedure for operation and calibration of friability test apparatus 2.0 RESPONSIBILITY Quality Control Chemist / QA Chemist 3.0 ACCOUNTABILITY Quality Control Manager / QA Manager. 4.0 PROCEDURE GENERAL CLEANING 4.1 Clean the apparatus free of dust with dry … Read more
sop for approval and rejection of packaging materials 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe the procedure for Approval and Rejection of Packaging Material. 2.0. RESPONSIBILITY: 2.1 The Chemist / Officer – Quality Control Packaging shall be: 2.1.1. Responsible for ensuring proper documentation of sampling and adequate number of … Read more
sop for non conformance of RM PM and finished product 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe a procedure for Handling of Non Conformance (NCR) of Raw Material (RM) / Packaging Material (PM) and Finished Product (FP). 1.1.1 Raw material / finished product which conforms to Regulatory specifications but does … Read more
sop for collection storage and disposal of control samples 1.0 OBJECTIVE: The objective of this SOP is: 1.1 To describe the procedure for collection, storage and disposal of control samples. 2.0 RESPONSIBILITIES: 2.1 Quality Assurance Officer shall be: 2.1.1 Responsible for collection of control sample of finished products. 2.1.2 Updation of Control Sample … Read more
sop for trend analysis of finished products 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe a procedure for Trend Analysis of finished products. 2.0. RESPONSIBILITY: 2.1 Head of the Quality Control shall be: 2.1.1. Responsible for preparing the trend analysis of finished products by considering the Analytical parameters. 2.2 … Read more
sop for Chromatographic practices and system suitability 1.0. OBJECTIVE: To lay down a procedure for Chromatographic practices and system suitability. 2.0. SCOPE: This SOP is applicable for procedure of Chromatographic practices and system suitability in quality control department 3.0. RESPONSIBILITY: Executive /Officer QC 4.0 ACCOUNTABILITY: Head- Quality Control 5.0 DEFINITION: Chromatography is a … Read more
SOP For Good Laboratory Practices 1.0. OBJECTIVE 1.1 To lay down a procedure for Good Laboratory Practices in Quality Control Laboratory. 2.0. SCOPE 2.1 This procedure is applicable Good Laboratory Practices in Quality Control Laboratory 3.0. RESPONSIBILITY 3.1 QC Officer or QC Executive 4.0. ACCOUNTABILITY 4.1 QC Manager 5.0. DEFINITION: Good Laboratory Practices … Read more
sop for cleaning and operation of sieve shaker 1.0 OBJECTIVE 1.1 To lay down a procedure for Cleaning and Operation of Sieve Shaker. 2.0 SCOPE 2.1 This procedure is applicable Cleaning and Operation of Sieve Shaker in Quality Control Department 3.0 RESPONSIBILITY 3.1 Officer / Executive to follow up the procedure for Cleaning … Read more