SOP for Finished Product Release Standard Operating Procedure for Finished Product Release in Otic Manufacturing Unit 1) Purpose To establish procedures for the release of finished Otic (Ear) Dosage Forms products, ensuring they meet all quality, safety, and regulatory requirements before distribution. 2) Scope This SOP applies to the final inspection, testing, and release of…

SOP for Labeling and Packaging Control Standard Operating Procedure for Labeling and Packaging Control in Otic Manufacturing Unit 1) Purpose To establish procedures for controlling labeling and packaging operations in the manufacturing of Otic (Ear) Dosage Forms to ensure accurate labeling, packaging integrity, and compliance with regulatory requirements. 2) Scope This SOP applies to all…

SOP for Deviation and Out-of-Specification (OOS) Handling Standard Operating Procedure for Deviation and Out-of-Specification (OOS) Handling in Otic Manufacturing Unit 1) Purpose To establish procedures for handling deviations and out-of-specification (OOS) results encountered during the manufacturing, testing, or packaging of Otic (Ear) Dosage Forms to ensure product quality, safety, and compliance with regulatory requirements. 2)…

SOP for Change Control Management Standard Operating Procedure for Change Control Management in Otic Manufacturing Unit 1) Purpose To establish procedures for managing changes in processes, systems, equipment, and documentation within the Otic manufacturing unit to ensure controlled implementation, evaluation, and communication of changes. 2) Scope This SOP applies to all changes initiated within the…

SOP for Cleaning Validation Standard Operating Procedure for Cleaning Validation in Otic Manufacturing Unit 1) Purpose To establish procedures for cleaning validation in the manufacturing of Otic (Ear) Dosage Forms to ensure cleanliness, prevent cross-contamination, and comply with regulatory requirements. 2) Scope This SOP applies to all equipment and facilities used in the manufacturing, packaging,…

SOP for In-process Control and Sampling Standard Operating Procedure for In-process Control and Sampling in Otic Manufacturing Unit 1) Purpose To establish procedures for conducting in-process controls and sampling during the manufacturing of Otic (Ear) Dosage Forms to ensure product quality, consistency, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel…

SOP for Batch Record Preparation and Review Standard Operating Procedure for Batch Record Preparation and Review in Otic Manufacturing Unit 1) Purpose To establish guidelines for the preparation, completion, and review of batch records for Otic (Ear) Dosage Forms to ensure accuracy, completeness, and compliance with regulatory requirements. 2) Scope This SOP applies to all…

SOP for Manufacturing Process Control Standard Operating Procedure for Manufacturing Process Control in Otic Manufacturing Unit 1) Purpose To establish procedures for controlling and monitoring the manufacturing processes of Otic (Ear) Dosage Forms to ensure consistency, quality, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in the manufacturing processes…

SOP for Dispensing of Raw Materials Standard Operating Procedure for Dispensing of Raw Materials in Otic Manufacturing Unit 1) Purpose To establish guidelines for the accurate dispensing of raw materials used in the manufacturing of Otic (Ear) Dosage Forms to ensure product quality, traceability, and compliance with regulatory requirements. 2) Scope This SOP applies to…

SOP for Raw Material Handling and Sampling Standard Operating Procedure for Raw Material Handling and Sampling in Otic Manufacturing Unit 1) Purpose To establish procedures for the receipt, identification, handling, storage, and sampling of raw materials used in the manufacturing of Otic (Ear) Dosage Forms to ensure quality, traceability, and compliance with regulatory standards. 2)…