procedure for Quality Management 1.0 OBJECTIVE: 1.1 To lay down a procedure for Quality Management. 2.0 SCOPE: 2.1 This procedure is applicable for formulation plants of …… 3.0 RESPONSIBILITY: 3.1 Head Quality Assurance shall be responsible for compliance of this SOP 3.2 Heads of Production, QC, Warehouse, Engineering & HR etc. shall be … Read more
procedure for maximum retail price of finished product 1.0 OBJECTIVE: 1.1 To lay down a procedure for maximum retail price of finished product. 2.0 SCOPE: 2.1 This Standard Operating Procedure is applicable for maximum retail price of finished product to be followed at 3.0 RESPONSIBILITY: 3.1 Head / his designee / In-charge … Read more
Investigation and Root cause analysis 1.0 OBJECTIVE: To lay down the procedure for Investigation and Root cause analysis. 2.0 SCOPE: This procedure is applicable to abc company. facility for investigation and root cause analysis of un explained discrepancies resulting from below listed area but not limited to. 2.1 People 2.2 Process 2.3 Material … Read more
Sop for Cleaning Validation and Hold Time or Shelf Life Study Protocols and Reports OBJECTIVE: To lay down a Procedure for Preparation of Cleaning Validation and Hold Time/Shelf Life Study Protocols and Reports. 2.0 SCOPE: This SOP is applicable for Preparation of Cleaning Validation and Hold Time/Shelf Life Study Protocols and Reports in Quality Control … Read more
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