sop for environment monitoring program OBJECTIVE Lay down the procedure for environment monitoring program. 2.0 SCOPE This procedure is applicable for Drain, Compressed air Nitrogen air, microbiological environmental monitoring of area (Dry powder injection Block I and II /Microbiology laboratory/ Oral solid dose area) and personnel at M/s abc company 3.0 RESPONSIBILITY • Officer … Read more
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
job responsibilities of quality control manager 1) To ensure the compliance of current Good laboratory practices and standard operating procedures in trendy working techniques in the pleasant control Laboratory. The Quality Control Laboratory. 2) To ensure the testing, approval or rejection of all Raw-materials, packing materials, Bulk Finished & Finished products. 3) To … Read more
Preparation Filtration Usage and Destruction of Disinfectant Solution 1.0. OBJECTIVE : 1.1 To lay down a procedure for Preparation , Filtration ,Usage and destruction of Disinfectant Solution. 2.0 SCOPE : 2.1 This procedure is applicable for Preparation , Filtration ,Usage and destruction of Disinfectant Solution in Injection (Parenteral) at ……. 3.0 RESPONSIBILITY : 3.1 … Read more
sop for Return of Excess Packing Material 1.0 OBJECTIVE : 1.1 To lay down a procedure for Return of Excess Packing Material. 2.0. SCOPE : 2.1 This procedure is applicable for Return of Excess Packing Material at ……. 3.0. RESPONSIBILITY : 3.1 Supervisor / Officer production or designee. 4.0. ACCOUNTABILITY : 4.1 Production … 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