Material Management and Control in Vaginal Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to outline the procedures for the effective management and control of materials used in the manufacturing of vaginal dosage forms to ensure product quality and regulatory compliance.

2) Scope

This SOP applies to all materials, including raw materials, intermediates, packaging materials, and finished products, used in the manufacturing of vaginal dosage forms within the pharmaceutical facility.

3) Responsibilities

The Materials Management, Production, and Quality Assurance (QA) departments are responsible for implementing and adhering to this SOP.

4) Procedure

4.1 Material Procurement

1. Establish criteria for selecting and approving suppliers based on quality, reliability, and regulatory compliance.
2. Ensure all materials are procured from approved suppliers.
3. Document and maintain records of all procurement activities.

4.2 Material Receipt

1. Inspect incoming materials for damage, labeling accuracy, and compliance with specifications.
2. Verify materials against purchase orders and delivery documents.
3. Quarantine materials until they are sampled, tested, and approved by QA.

4.3 Material Storage

1. Store materials in designated areas with appropriate environmental controls to prevent contamination and degradation.
2. Segregate materials based on status (e.g., quarantined, released, rejected) and type (e.g., raw materials, packaging materials).
3. Maintain an inventory management system to track material status and location.

4.4 Material Sampling and Testing

1. Follow SOP for Raw Material Receipt and Sampling to collect samples for testing.
2. Perform testing according to approved specifications and methods.
3. Document and review test results. Approve materials that meet specifications and reject those that do not.

4.5 Material Dispensing

1. Dispense materials according to approved batch records and production requirements.
2. Ensure accurate weighing and labeling of dispensed materials.
3. Maintain records of dispensing activities, including quantities, lot numbers, and personnel involved.

4.6 Material Usage

1. Use materials in accordance with approved batch records and manufacturing instructions.
2. Document material usage, including quantities and batch numbers, in production records.

4.7 Material Return and Disposal

1. Quarantine and return materials that are no longer needed or are unsuitable for use.
2. Dispose of rejected or expired materials according to regulatory and environmental guidelines.
3. Document all material return and disposal activities.

4.8 Inventory Management

1. Maintain an accurate inventory of all materials, including quantities, lot numbers, and storage locations.
2. Perform regular inventory audits to ensure accuracy and identify discrepancies.
3. Implement a first-expiry, first-out (FEFO) system to manage material usage.

4.9 Documentation and Record Keeping

1. Maintain detailed records of all material management activities, including procurement, receipt, testing, storage, dispensing, usage, return, and disposal.
2. Ensure records are reviewed regularly and retained according to regulatory requirements.

4.10 Training

1. Provide training to personnel on material management procedures and documentation requirements.
2. Document training sessions and ensure all relevant staff are trained.

5) Abbreviations, if any

N/A

6) Documents, if any

Purchase orders, delivery documents, inspection records, test results, inventory records, production records, disposal records, training 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