sop for data integrity OBJECTIVE The purpose of the Data Integrity Standard Operating Procedure (SOP) is four-fold: 1.1.1 To describe the laboratory’s data integrity system, 1.1.2 To emphasize the paramount importance of ethics in the performance of all analytical work, 1.1.3 To obtain the commitment of laboratory staff to the principle that all … Read more
Procedure for Terminal Inspection and Transfer of Finished Goods 1.0 OBJECTIVE: 1.1 To lay down a procedure for Terminal Inspection and Transfer of Finished Goods. 2.0 SCOPE: 2.1 This SOP is applicable for Terminal Inspection and Transfer of Finished Goods 3.0 RESPONSIBILITY: 3.1 Officer / Executive- QA 4.0 ACCOUNTABILITY: 4.1 Head – QA … Read more
sop for Preparation and Approval of List of Authorized personnel 1.0. OBJECTIVE : 1.1 The objective of this sop is to define the procedure for Preparation of List of Authorized Personnel. 2.0. SCOPE : 2.1 This procedure is applicable to Preparation of List of Authorized Personnel of concerned department 3.0. RESPONSIBILITY : 3.1 … Read more
sop for Continues Product Quality Review 1.0 OBJECTIVE: 1.1 To lay down a procedure for Continues Product Quality Review for the products manufactured in a every three months. 2.0 SCOPE: 2.1 This Standard Operating Procedure is applicable for all products manufactured 3.0 RESPONSIBILITY: 3.1 Officer / Executive – QA shall be responsible for collection of … Read more
sop for Qualification of Visual Inspector 1.0 OBJECTIVE: 1.1 To lay down a procedure for Qualification of Visual Inspector. 2.0 SCOPE: 2.1 This Standard Operating Procedure is applicable for Qualification of Visual Inspector 3.0 RESPONSIBILITY: 3.1 Officer / Executive QA and Production 4.0 ACCOUNTABILITY: 4.1 Head – QA 5.0 PROCEDURE: Note: Each newly … Read more
sop for Trend Analysis of QMS Document 1.0 OBJECTIVE: 1.1 To lay down a procedure for preparation Trend Analysis of QMS Document (Deviation, Change control, Incident). 2.0 SCOPE: 2.1 This Standard Operating Procedure is applicable for the Trend Analysis of QMS Document (Deviation, Change control, Incident) 3.0 RESPONSIBILITY: 3.1 Officer/Executive-QA: Preparation, Review, Issuance, … Read more
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