Cleaning of Dispensing Area in Vaginal Dosage Forms Manufacturing

1) Purpose

The purpose of this SOP is to establish procedures for the cleaning and maintenance of the dispensing area in the manufacturing of vaginal dosage forms, ensuring cleanliness and compliance with hygiene standards.

2) Scope

This SOP applies to all personnel responsible for cleaning and maintaining the dispensing area at the pharmaceutical facility.

3) Responsibilities

The Warehouse and Production departments are responsible for implementing and adhering to this SOP.

4) Procedure

4.1 Pre-Cleaning Preparation

1. Ensure all dispensing activities are completed and all raw materials are properly stored or disposed of.
2. Remove all equipment and materials from the dispensing area.

4.2 Cleaning Process

1. Sweep or vacuum the floor to remove any debris or spills.
2. Wipe down all surfaces, including shelves, countertops, and equipment, using approved cleaning agents and disinfectants.
3. Focus on high-touch areas and corners where dust and dirt may accumulate.

4.3 Sanitization

1. Apply a sanitizing solution to all cleaned surfaces, ensuring adequate contact time as per the manufacturer’s instructions.
2. Rinse sanitized surfaces with clean water to remove any residue.

4.4 Drying and Inspection

1. Air dry or use clean, disposable towels to dry all surfaces thoroughly.
2. Inspect the cleaned area for cleanliness and any potential issues.

4.5 Reassembly and Final Check

1. Return cleaned equipment and materials to their designated places in the dispensing area.
2. Verify that all items are properly stored and labeled.

4.6 Post-Cleaning Documentation

1. Document the cleaning activities in the cleaning log, noting the date, time, and personnel responsible.
2. Record any deviations or issues encountered during the cleaning process.

5) Abbreviations, if any

None

6) Documents, if any

Cleaning log, cleaning agents and disinfectants specifications

7) Reference, if any

USP Chapter 1072: Disinfectants and Antiseptics, FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice

8) SOP Version

Version 1.0