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 all personnel involved in the dispensing of raw materials within the manufacturing facility.
3) Responsibilities
Dispensing Personnel: Responsible for accurately dispensing raw materials as per batch records.
Quality Assurance (QA) Department: Responsible for oversight and approval of dispensing activities.
Production Supervisors: Responsible for ensuring the availability of materials and coordinating dispensing activities with production schedules.
4) Procedure
4.1 Material Request
4.1.1 Batch Record Review
4.1.1.1 Review the batch record to identify the raw materials required for dispensing.
4.1.1.2 Ensure availability of materials and check expiration dates before dispensing.
4.1.2 Material Requisition
4.1.2.1 Submit a material requisition form specifying the quantity and identity of raw materials required.
4.1.2.2 Obtain approval from QA for the material requisition.
4.2 Dispensing Process
4.2.1 Weighing and Measurement
4.2.1.1 Use calibrated weighing scales and measuring devices for accurate dispensing.
4.2.1.2 Follow batch record instructions and dispensing procedures meticulously.
4.2.2 Double-checking
4.2.2.1 Perform a double-check of dispensed materials against batch record specifications.
4.2.2.2 Record actual quantities dispensed and any discrepancies encountered.
4.3 Labeling and Identification
4.3.1 Labeling
4.3.1.1 Label containers of dispensed materials with appropriate identification details (e.g., name, lot number).
4.3.1.2 Include “Dispensed” label to distinguish from raw materials in quarantine.
4.3.2 Storage
4.3.2.1 Transfer dispensed materials to designated storage areas following proper segregation protocols.
4.3.2.2 Ensure storage conditions meet specified requirements (e.g., temperature, humidity).
4.4 Documentation and Recordkeeping
4.4.1 Batch Record Updates
4.4.1.1 Document all dispensing activities in the batch record, including quantities dispensed and any deviations.
4.4.1.2 Obtain QA approval for completed dispensing activities.
4.4.2 Material Inventory
4.4.2.1 Update material inventory records to reflect dispensed quantities and current stock levels.
4.4.2.2 Maintain accurate records of material usage and availability.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
GMP: Good Manufacturing Practices
6) Documents, if any
Material requisition forms
Batch records
Dispensing logs and records
7) Reference, if any
GMP guidelines for dispensing of raw materials in pharmaceutical manufacturing
8) SOP Version
Version 1.0
