Raw Material Dispensing Procedures in Vaginal Dosage Forms Manufacturing

1) Purpose

The purpose of this SOP is to establish procedures for the accurate and controlled dispensing of raw materials used in the manufacturing of vaginal dosage forms, ensuring consistency and compliance with quality standards.

2) Scope

This SOP applies to all personnel involved in the dispensing of raw materials for the production of vaginal dosage forms at the pharmaceutical facility.

3) Responsibilities

The Warehouse, Production, and Quality Control (QC) departments are responsible for implementing and adhering to this SOP.

4) Procedure

4.1 Preparation for Dispensing

1. Verify the production schedule and batch records to determine the raw materials and quantities required for dispensing.
2. Ensure the dispensing area is clean, organized, and free from contaminants before starting the dispensing process.
3. Check and calibrate weighing scales and other dispensing equipment to ensure accuracy.

4.2 Raw Material Identification and Verification

1. Retrieve the required raw materials from the storage area, ensuring they are correctly labeled and within their expiration dates.
2. Verify the identity and quantity of each raw material against the batch record and material specification sheet.
3. Record the verification details in the batch record or dispensing log.

4.3 Weighing and Dispensing

1. Place a clean container on the weighing scale and tare the scale to zero.
2. Weigh the required quantity of each raw material accurately, following the specified tolerances in the batch record.
3. Transfer the dispensed material to a labeled container, noting the material name, batch/lot number, and weight.
4. For critical raw materials, perform a second check by another qualified person to verify the dispensed quantity.
5. Record the dispensed quantities and verification details in the batch record or dispensing log.

4.4 Handling and Transporting Dispensed Materials

1. Handle dispensed raw materials carefully to avoid contamination or spillage.
2. Use appropriate handling equipment, such as carts or trolleys, to transport dispensed materials to the production area.
3. Ensure that containers are securely covered and labeled during transport.

4.5 Documentation and Record Keeping

1. Maintain detailed records of the dispensing process, including raw material identity, quantities, batch/lot numbers, and verification details.
2. Document any deviations from the specified dispensing process and investigate their impact on product quality.
3. Retain dispensing records according to regulatory requirements.

4.6 Cleaning and Maintenance

1. Clean and sanitize the dispensing area and equipment after each use to prevent cross-contamination.
2. Perform routine maintenance and calibration of weighing scales and other dispensing equipment as per the equipment maintenance schedule.

4.7 Training

1. Provide training to personnel involved in the dispensing process on the procedures and documentation requirements outlined in this SOP.
2. Document all training sessions and ensure all relevant staff are trained.

5) Abbreviations, if any

QC – Quality Control

6) Documents, if any

Batch records, material specification sheets, dispensing logs, equipment calibration logs

7) Reference, if any

FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations, ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0