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
Entry and Exit Procedure into injection Parenteral Area 1.0 OBJECTIVE: 1.1 To lay down the Procedure for Entry and Exit into Injection Parenteral Area. 2.0 SCOPE: 2.1 This SOP is applicable for Entry and Exit Procedure into Injection (Parenteral) Area at …… 3.0 RESPONSIBILITY: 3.1 All Officer/Executive/Employee 4.0 ACCOUNTABILITY: 4.1 Production Head 5.0 … Read more
Media received and preparation Management 1.0 OBJECTIVE Lay down the procedure for Media received and preparation Management 2.0 SCOPE This procedure is applicable for Lab media management at …… 3.0 RESPONSIBILITY • Department microbiologist, officer and executive shall be responsible to follow the procedure of preparation and usage of sterile media as per … 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
Operation and cleaning of Automatic Four Head ROPP Cap Sealing Machine 1.0 OBJECTIVE : 1.1 To lay down a procedure for Operation and cleaning of Automatic Four Head R.O.P.P. Cap Sealing Machine. 2.0. SCOPE : 2.1 This procedure is applicable to Operation and cleaning of Automatic Four Head R.O. P. P. Cap Sealing … 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