performance qualification protocol for water for injection EQUIPMENT ID. No. LOCATION WFI GENERATION AREA SUPERSEDES PROTOCOL No. NIL PROTOCOL CONTENTS S. NO. TITLE PAGE NO. 1.0 PROTOCOL APPROVAL 2.0 OBJECTIVE 3.0 SCOPE 4.0 RESPONSIBILITY 5.0 EQUIPMENT DETAILS 6.0 SYSTEM … Read more
preparation for Sampling Intimation slip 1.0 OBJECTIVE: To lay down a Sampling Intimation for Process Validation / Equipment Qualification / Utility Qualification Cleaning Validation / Hold time study samples. 2.0 SCOPE: This SOP is applicable for Sampling Intimation for Process Validation / Equipment Qualification / Utility Qualification / Cleaning validation / Hold time … Read more
Preparation of Validation and Qualification Protocols and Reports 1.0 OBJECTIVE: To lay down a Procedure for Preparation of Validation and Qualification Protocols and Reports. 2.0 SCOPE: This SOP is applicable for Preparation of Validation and Qualification Protocols and Reports at ……….. 3.0 RESPONSIBILITY: QA (Officer/ Designee): Preparation, Distribution (to Respective Department), Revision, Retrieval and … Read more
Handling of Incident during operation 1.0 OBJECTIVE : 1.1 To lay down a procedure for handling, reporting, investigation and closing of incident during operation. 2.0 SCOPE : 2.1 This Standard Operating Procedure is applicable for all Incidents during operation and that can directly/ indirectly affect the quality of the product to be followed … Read more
Handing of Product Recall 1.0 OBJECTIVE: 1.1 To lay down a procedure for product recall and handling of recalled products. 2.0 SCOPE: 2.1 This Standard Operating Procedure is applicable for recall of drug products and handling of recalled drug products manufactured at….. 3.0 RESPONSIBILITY: 3.1 Head-Quality Assurance shall be responsible for the coordination … Read more
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