sop for Corrective and Preventive Action 1.0 OBJECTIVE: 1.1 To lay down the procedure for handling of Corrective and Preventive Action. 2.0 SCOPE: 2.1 This SOP is applicable for all Corrective and Preventive Action that are recommended if any, but not limited to the following documents: 2.1.1 Deviation 2.1.2 Out of specification … Read more
Preparation of Site Master File 1.0 OBJECTIVE : 1.1 To lay down a procedure for preparation of Site Master File. 2.0 SCOPE : 2.1 This procedure is applicable for preparation of Site Master File at ABC pharma Private Limited Roorkee. 3.0 RESPONSIBILITY : 3.1 Officer / Executive QA or designee shall be … Read more
Collection Storage Periodic Observation and Destruction of Raw Material and Finished Product Reference Samples 1.0 OBJECTIVE : 1.1 To lay down a procedure for collection and storage of raw material and finished product reference samples as well as periodic observation of Finished Product Reference sample. 2.0 SCOPE : 2.1 This procedure is applicable … Read more
Preparation Approval Control and Distribution of Master Formula Records 1.0 OBJECTIVE : 1.1 To lay down a procedure for preparation, approval, control and distribution of Master Formula Records for manufacturing as well as packing of finished pharmaceutical products. 2.0 SCOPE : 2.1 This procedure is applicable to preparation, approval, control and distribution of … Read more
Retention and disposal of documents and records OBJECTIVE : 1.1 To lay down a procedure for retention of obsolete/discontinued documents and filled records and disposal after retention period. 2.0. SCOPE : 2.1 This procedure is applicable to obsolete/discontinued documents as well as filled records being … 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
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