sop for evaluation and qualification of vendor who supply packing material OBJECTIVE 1.1 To describe a procedure for evaluation and qualification of vendor who supply packing material. SCOPE 2.1 This procedure is applicable to all vendor, who are supplying packing materials at RESPONSIBILITY 3.1 Purchase Department shall search the suitable vendor for requirements … Read more
sop of general Non-Conformance incidence 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe a procedure for handling of any observation of general Non-Conformance incidence. 2.0. RESPONSIBILITY: 2.1 Head of the Concerned Department / In-Process QA Personnel shall be: 2.1.1. Responsible for intimating the non-Conformance incidents to Quality Assurance through General Non-Conformance … Read more
Sop of Handling of out date documents SUBJECT STANDARD OPERATING PROCEDURE SOP NUMBER DEPARTMENT QUALITY ASSURANCE & REGULATORY AFFAIRS EFFECTIVE DATE REVISION NUMBER TITLE HANDLING OF OUT DATE DOCUMENTS REVIEW DATE APPROVAL LIST DESIGNATION NAME SIGNATURE DATE PREPARED BY REVIEWED BY Executive … Read more
process validation protocol for methylcobalamin niacinamide and pyridoxine injection SUPERSEDES PROTOCOL No. DATE OF VALIDATION VALIDATION BATCH NUMBERS VALIDATION BATCH SIZE PROTOCOL CONTENTS S. NO. TITLE 1.0 PROTOCOL APPROVAL 2.0 OBJECTIVE 3.0 SCOPE 4.0 RESPONSIBILITY … Read more
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