SOP for Management of Returned Goods Standard Operating Procedure for Management of Returned Goods in Otic Manufacturing Unit 1) Purpose To establish procedures for the handling, investigation, and disposition of returned goods from customers or distributors to ensure compliance, product safety, and customer satisfaction. 2) Scope This SOP applies to all returned goods received by…

SOP for Management of Returned Goods Standard Operating Procedure for Management of Returned Goods in Otic Manufacturing Unit 1) Purpose To establish procedures for the handling, investigation, and disposition of returned goods from customers or distributors to ensure compliance, product safety, and customer satisfaction. 2) Scope This SOP applies to all returned goods received by…

SOP for Validation of Processes and Methods Standard Operating Procedure for Validation of Processes and Methods in Otic Manufacturing Unit 1) Purpose To establish procedures for the validation of processes and analytical methods used in the manufacturing of Otic (Ear) Dosage Forms to ensure reliability, accuracy, and consistency of results. 2) Scope This SOP applies…

SOP for Self-Inspection and Internal Audits Standard Operating Procedure for Self-Inspection and Internal Audits in Otic Manufacturing Unit 1) Purpose To establish a framework for conducting self-inspections and internal audits within the Otic manufacturing unit to ensure compliance with Good Manufacturing Practices (GMP) and internal quality standards. 2) Scope This SOP applies to all departments…

SOP for Vendor Qualification and Management Standard Operating Procedure for Vendor Qualification and Management in Otic Manufacturing Unit 1) Purpose To establish criteria and procedures for the qualification, selection, evaluation, and ongoing management of vendors supplying materials and services to the Otic manufacturing unit, ensuring compliance with quality standards and regulatory requirements. 2) Scope This…

SOP for Product Recalls Standard Operating Procedure for Product Recalls in Otic Manufacturing Unit 1) Purpose To establish procedures for initiating, managing, and completing product recalls of Otic (Ear) Dosage Forms to protect public health and comply with regulatory requirements. 2) Scope This SOP applies to all personnel involved in identifying, assessing, initiating, and executing…

SOP for Complaint Handling Standard Operating Procedure for Complaint Handling in Otic Manufacturing Unit 1) Purpose To establish procedures for receiving, documenting, evaluating, investigating, and resolving complaints related to Otic (Ear) Dosage Forms to ensure customer satisfaction and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in the receipt, assessment,…

SOP for Training of Personnel Standard Operating Procedure for Training of Personnel in Otic Manufacturing Unit 1) Purpose To establish procedures for training personnel involved in the manufacturing of Otic (Ear) Dosage Forms to ensure competency, compliance, and adherence to Good Manufacturing Practices (GMP). 2) Scope This SOP applies to all personnel engaged in manufacturing,…

SOP for Stability Studies and Monitoring Standard Operating Procedure for Stability Studies and Monitoring in Otic Manufacturing Unit 1) Purpose To establish procedures for conducting stability studies and monitoring of Otic (Ear) Dosage Forms to ensure product quality and shelf-life determination. 2) Scope This SOP applies to all stability studies conducted on raw materials, intermediates,…

SOP for Quality Control Testing and Release Standard Operating Procedure for Quality Control Testing and Release in Otic Manufacturing Unit 1) Purpose To establish procedures for conducting quality control testing and releasing raw materials, intermediates, and finished Otic (Ear) Dosage Forms products to ensure compliance with specifications and regulatory requirements. 2) Scope This SOP applies…