sop for Cleaning of Utensils 1.0 OBJECTIVE: To lay down the procedure for Cleaning of Utensils. 2.0 SCOPE: This SOP is applicable for cleaning of SS bins & containers, Pallets, Hose pipes and Accessories. 3.0 RESPONSIBILITY: Production: To perform and check the defined procedure. Head Production: To ensure execution & compliance. QA: To … Read more
Protocol for re-validation of dry heat sterilizer Equipment Name : Dry Heat Sterilizer Equipment ID : Protocol Approval Date : … Read more
sop for handling of external audits 1.0 OBJECTIVE: To lay down a Procedure for handling of external audits or inspections from Regulatory agency, 2.0 SCOPE: This SOP is applicable for handling of external audits or inspections from Regulatory agency, 3.0RESPONSIBILITY: QA (Officer/ Executive): Preparation, Distribution (to Respective Departments), Revision, Retrieval & Destruction … Read more
sop for Checking of Proof and Overprinting 1.0 PURPOSE To define a procedure for checking of proof of foil, label, enclosure, carton and shipper. 2.0 SCOPE 2.1 This procedure applies to proof of foil, label, enclosure, carton and shipper in packing department at QC 3.0 RESPONSIBILITY: Officer/Executive 4.0 ACCOUNTABILITY: Head- Quality Control … Read more
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