validation protocol of sterility test SR. NO. PARTICULARS 1.0 APPROVAL SIGNATURES 2.0 OBJECTIVE 3.0 SCOPE 4.0 PRE-REQUISITES 5.0 RESPONSIBILITIES 6.0 REFERENCE DOCUMENTS 7.0 EXPERIMENTAL DETAILS 7.1 PRODUCT NAME 7.2 BATCH NO. 7.3 QUANTITY OF SAMPLE 7.4 FILTER TYPE … Read more
sop for Analytical Method Transfer Analytical Method Transfer 1.0 PURPOSE To define a procedure for transfer of analytical methods from one laboratory to other laboratory. SCOPE This procedure is applicable to the transfer of analytical method (drug substances and medication items) for assay, related substances, dissolution, preservative/antioxidant content, uniformity content, residual solvents … Read more
PROTOCOL FOR HOLD TIME STUDY OF STERILE GARMENTS S. NO. TITLE PAGE NO. 1. PROTOCOL PRE APPROVAL 2. OBJECTIVE 3. SCOPE 4. RESPONSIBILITY 5. REASON FOR VALIDATION 6. TRAINING RECORD 7. OVERVIEW FOR HOLD TIME STUDY OF STERILE GARMENTS 8. PROCEDURE 9. ACCEPTANCE CRITERIA 10. FAILURE INVESTIGATION AND CORRECTIVE ACTION 11. DOCUMENTATION 12. REVALIDATION … Read more
sop for process validation 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe the procedure for process validation. 2.0. RESPONSIBILITY: 2.1 The Officer – Quality Assurance 2.1.1. Responsible to carry out the sampling as per sampling plan mentioned in validation protocol. 2.1.2. Responsible for sending intimation on sample withdrawal to … Read more
sop for monitoring of water purification and distribution system 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe the procedure for monitoring of Water Purification, Storage and Distribution System in Cephalosporin Block and Warehouse. 2.0. RESPONSIBILITY: 2.1 The QC Officer shall be: 2.1.1. Responsible for sampling as per the sampling schedule. … Read more
sop for validation of incubators 1.0 OBJECTIVE To lay down a procedure for validation of incubator in microbiology laboratory. 2.0 RESPONSIBILTY Microbiologist / Executive. 3.0 ACCOUNTABILITY Quality Assurance Manager 4.0 PROCEDURE 4.1 Details of the Standard thermometer used for validation of Lab thermometer. 4.2 Type : Liquid – Glass lab Thermometer. 4.3 … Read more
sop for of environmental conditions of control sample room 1.0. PURPOSE: To lay down the procedure for daily monitoring of environmental conditions i.e. Temperature and Relative Humidity in Control Sample Room 2.0. RESPONSIBILITY: 4.1 The Officer Quality Assurance shall be: 4.1.1 Responsible for daily monitoring the environmental conditions 4.1.2 Responsible for recording … Read more
sop for Handling of poisonous and hazardous chemicals . 1.0 OBJECTIVE 0y down procedure for handling of poisonous and hazardous chemicals. 2.0 RESPONSIBILITY Q.C. Chemist / Q.C Executive. 3.0 ACCOUNTABILITY Manager Q.A. 4.0 PROCEDURE 4.1 Store all poisonous chemicals in well isolated place under lock and key. 4.2 Always use necessary safety devices while … Read more
sop for swab sampling for validation of clean surfaces 1.0 OBJECTIVE To establish a procedure for swab sampling for validation of test surface to evaluate cleaning efficacy. 2.0 RESPONSIBILITY Quality Control Supervisor 3.0 ACCOUNTABILITY Quality Control Manager 4.0 PROCEDURE FOR CHEMICAL EVALUATION 4.1 SWAB : A clean room laundered polyurethane foam swab molded … Read more
sop for failure investigation 1.0 OBJECTIVE To lay down a procedure for investigation any failures in product, process or systems which may affect the quality of the finished product. 2.0 RESPONSIBILITY Production Manager/Quality Assurance Manager. 3.0 ACCOUNTABILITY Plant Head 4.0 Procedure 4.1 Failure investigation shall be carried out when a product does not … Read more