SOP for Finished Product Release

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…

SOP for Labeling and Packaging Control

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…

SOP for Deviation and Out-of-Specification (OOS) Handling

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…

SOP for Change Control Management

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…

SOP for Cleaning Validation

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…

SOP for In-process Control and Sampling

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…

SOP for Batch Record Preparation and Review

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…

SOP for Manufacturing Process Control

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…

SOP for Dispensing of Raw Materials

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…

SOP for Raw Material Handling and Sampling

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,…