Raw Material Receipt and Sampling for Vaginal Dosage Forms

1) Purpose

The purpose of this SOP is to define the procedure for the receipt and sampling of raw materials used in the manufacturing of vaginal dosage forms, ensuring their quality and compliance with regulatory standards.

2) Scope

This SOP applies to all raw materials received for the manufacturing of vaginal dosage forms at the pharmaceutical facility.

3) Responsibilities

The Warehouse, Quality Control (QC), and Quality Assurance (QA) departments are responsible for the implementation and adherence to this SOP.

4) Procedure

4.1 Raw Material Receipt

1. Verify delivery documents against purchase orders for accuracy and completeness.
2. Inspect the delivery vehicle for cleanliness and any signs of contamination or damage.
3. Check the condition of the raw material containers for integrity and labeling accuracy.
4. Record the receipt of raw materials in the inventory management system, including the date of receipt, supplier details, and batch/lot numbers.
5. Quarantine all received materials in a designated area until they are sampled and tested.

4.2 Raw Material Sampling

1. QC personnel should don appropriate personal protective equipment (PPE) before entering the sampling area.
2. Ensure the sampling area is clean and free from contaminants.
3. Refer to the material specification sheet to determine the sampling plan and quantity to be sampled.
4. Use clean, sanitized sampling tools and containers for each material.
5. Label the samples with the material name, batch/lot number, date of sampling, and sampler’s initials.
6. Record the details of the sampling process in the sampling logbook.

4.3 Sample Testing and Approval

1. Submit the collected samples to the QC laboratory for testing according to approved specifications and methods.
2. QC personnel shall test the samples for identity, purity, potency, and other specified parameters.
3. QA personnel will review the test results and approve or reject the raw material based on compliance with the specifications.
4. Update the status of the raw material in the inventory management system to reflect its approval or rejection.

4.4 Storage of Raw Materials

1. Transfer approved raw materials to the designated storage area under specified conditions to prevent contamination and degradation.
2. Store materials in a manner that allows for easy identification, traceability, and retrieval.
3. Rejected materials should be clearly labeled and stored separately from approved materials to prevent accidental use.

4.5 Documentation and Record Keeping

1. Maintain detailed records of all raw material receipts, inspections, samplings, and test results.
2. Ensure records are reviewed regularly and retained according to regulatory requirements.

4.6 Training

1. Provide training to personnel involved in the receipt and sampling of raw materials 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

PPE – Personal Protective Equipment
QC – Quality Control
QA – Quality Assurance

6) Documents, if any

Purchase orders, delivery documents, sampling logbook, material specification sheets, test results, inventory records

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