sop for Retesting and resampling of raw materials 1.0 OBJECTIVE To lay down a procedure for Retesting and Re sampling of Raw materials lying in warehouse for Longer period. 2. RESPONSIBILITY Chemist / Executive 3. ACCOUNTABILITY Manager Q.C 4. PROCEDURE 4.1 Re sampling of a material will be done as and when … Read more
sop for Control of issuance of record of analysis green sheets 1.0 OBJECTIVE To lay down a procedure for control of Record of analysis (Green sheet) 2.0 RESPONSIBILITY Quality Control Officer 3.0 ACCOUNTABILITY Quality Control Manager. 4.0 PROCEDURE All green sheets used for record of analysis shall be pre numbered. 4.2 The numbers … Read more
sop for Control of computer passwords 1.0 OBJECTIVE To lay down a procedure for controlling the computer passwords. 2.0 RESPONSIBILITY Executives – Quality assurance and quality control. 3.0 ACCOUNTABILITY Head – QA. 4.0 PROCEDURE 4.1 All the computers used in the laboratory shall have password to avoid unauthorized use. 4.2 Respective section head shall … Read more
sop for sampling of packaging materials PM 1.0 OBJECTIVE: To lay down a procedure for sampling of packing materials so as to get the representative sample of the whole lot. 2.0 RESPONSIBILITY 2.1 The Officer / Assistant – Quality Control Packaging 2.2 The Executive – Quality Assurance 3.0 ACCOUNTABILITY Executive – Quality Assurance … Read more
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