sop for outsourcing 1.0 OBJECTIVE: 1.1 To lay down a Procedure for outsourcing. 2.0 SCOPE: 2.1 This Standard Operation Procedure is applicable to outsourcing 3.0 RESPONSIBILITY: 3.1 Officer / Executive- QA shall be responsible for monitoring this SOP. 3.2 All department head responsible for implementation of this SOP. 3.3 Head – QA or his designee … Read more
procedure for cleaning validation 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe a procedure for cleaning validation 2.0. RESPONSIBILITY: 2.1 The Officer – Quality Assurance shall be: 2.1.1. Responsible for carry out the sampling as per sampling plan mentioned in protocol. 2.1.2. Responsible for sending intimation to Quality control for … Read more
sop for Media Fill Study 1.0 OBJECTIVE: 1.1 To lay down a procedure for Media Fill Study. 2.0 SCOPE: 2.1 This Standard Operating Procedure is applicable for the Aseptic process simulation with documentary evidence in Liquid injection block 3.0 RESPONSIBILITY: 3.1 Quality Assurance To organize the Activity. To prepare the Protocol and Report. To … Read more
ANALYTICAL METHOD VALIDATION PROTOCOL FOR BENZYL ALCOHOL BY HPLC Name of Product BENZYL ALCOHOL Parameter Analytical Method Validation for Benzyl Alcohol by HPLC Method followed By HPLC Supersede No. Nil Total No of pages Effective Date Sr. No. Title Page — Product Description — Table of contents 1.0 … Read more
GLASSWARE CLEANING VALIDATION Name of Product GLASSWARE CLEANING VALIDATION Parameter GLASSWARE CLEANING VALIDATION Method followed BY UV Supersede No. Nil Total No of pages Effective Date Sr. No. Title Page — Product Description — Table of contents 1.0 Document Preparation and Protocol Approval 2.0 Revision Control … Read more
sop for collection storage and analysis of post production stability study 1.0 OBJECTIVE To lay down a procedure for collection, storage and analysis of post production stability study samples of various finished products. 2.0 RESPONSIBILITY Quality Control Supervisor. 3.0 ACCOUNTABILITY Assistant Quality Control Manager / Quality Control Manager. 4.0 PROCEDURE 4.1 The … Read more
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