Standard Operating Procedure for Handling System for Raw Materials in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish guidelines for the proper handling of raw materials used in the manufacturing of ocular dosage forms, ensuring safe and efficient material handling practices.

2) Scope

This SOP applies to all stages of raw material handling within the pharmaceutical manufacturing facility, including receipt, storage, dispensing, and transfer to production areas.

3) Responsibilities

Warehouse personnel are responsible for the receipt, storage, and dispensing of raw materials according to this SOP. Production personnel are responsible for transferring raw materials to designated production areas.

4) Procedure

4.1 Receipt of Raw Materials

1. Receive raw materials from approved suppliers as per the receipt procedure outlined in SOP [Insert SOP Number for Receipt of Raw Materials].
2. Verify the quantity and quality of received raw materials against accompanying documentation (e.g., Certificate of Analysis, Supplier Material Safety Data Sheets).
3. Label each received raw material container with an identification number, batch/lot number, and expiration date (if applicable).
4. Store raw materials in designated storage areas based on storage conditions specified in the respective Material Safety Data Sheets (MSDS).

4.2 Storage of Raw Materials

1. Ensure that storage conditions (e.g., temperature, humidity) for each raw material are maintained as per specifications provided in the MSDS.
2. Monitor and record storage conditions regularly to ensure compliance with specified limits.

4.3 Dispensing of Raw Materials

1. Dispense raw materials for production based on approved material requisitions and batch records.
2. Ensure accurate weighing or measuring of dispensed raw materials as per the requirements specified in the batch record.
3. Label dispensing containers with relevant information, including material name, batch/lot number, and quantity dispensed.

4.4 Transfer of Raw Materials

1. Transfer dispensed raw materials to designated production areas using appropriate handling equipment (e.g., trolleys, pallet jacks).
2. Ensure that transfer routes are clear and free from obstacles to prevent accidents or contamination.
3. Document transfer activities in the batch production record and maintain traceability of raw materials.

4.5 Cleaning and Maintenance of Handling Equipment

1. Clean and sanitize handling equipment regularly to prevent cross-contamination between different raw materials.
2. Perform routine maintenance checks on handling equipment to ensure proper functioning and safety during material handling operations.

4.6 Environmental Monitoring

1. Monitor environmental conditions (e.g., temperature, humidity) in storage and handling areas using calibrated monitoring equipment.
2. Record environmental monitoring data and investigate deviations from specified limits according to the facility’s environmental monitoring program.

4.7 Documentation

1. Maintain accurate records of all raw material handling activities, including receipts, dispensing, transfers, and environmental monitoring.
2. Ensure all documentation is completed accurately, signed, and dated by authorized personnel.

4.8 Training

1. Provide training to personnel involved in raw material handling on the procedures outlined in this SOP and related safety practices.
2. Ensure personnel are competent and aware of the importance of adhering to SOPs to maintain product quality and safety.

5) Abbreviations, if any

SOP: Standard Operating Procedure

MSDS: Material Safety Data Sheets

6) Documents, if any

1. Raw material receipt records
2. Material requisitions
3. Batch production records
4. Environmental monitoring records

7) Reference, if any

GMP Guidelines for Pharmaceutical Manufacturing

8) SOP Version

Version 1.0