Standard Operating Procedure for Cleaning of Dispensing Area Before and After Use

Department	Elixir Department
SOP No.	SOP/ELX/008/2025
Supersedes	SOP/ELX/008/2022
Page No.	Page 1 of 8
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To establish a standard procedure for the effective cleaning of the dispensing area before and after its use in order to maintain hygiene, avoid cross-contamination, and comply with GMP requirements during the preparation of materials for elixir manufacturing.

2. Scope

This SOP is applicable to all personnel involved in the cleaning and preparation of the dispensing area located within the Elixir Department. It includes procedures for cleaning prior to dispensing activity and post-use cleaning at the end of the activity or batch.

3. Responsibilities

• Warehouse Assistant:
  • Carry out cleaning activities using approved materials and procedures.
  • Document all cleaning in the Cleaning Logbook.
• Warehouse Supervisor:
  • Verify cleaning has been completed as per the SOP.
• QA Personnel:
  • Review and sign off line clearance and cleanliness prior to and after dispensing.

4. Accountability

The Head of Warehouse and the Head of Quality Assurance are accountable for ensuring proper implementation and documentation of cleaning procedures in the dispensing area.

5. Procedure

5.1 Cleaning Before Use

1. Ensure the area is free from any previous material residues or used equipment.
2. Clean the floor using a mop soaked in a freshly prepared solution of 0.5% Detergent followed by 70% IPA.
3. Wipe all working surfaces, equipment tables, and balance platforms using lint-free cloth and IPA 70%.
4. Clean weighing balances with a dry cloth followed by a cloth dipped in IPA 70%.
5. Use separate dedicated mops and cleaning cloths for the dispensing area only.
6. Allow surfaces to dry before beginning dispensing activity.
7. Record the activity in the Cleaning Logbook (Annexure-1).

5.2 Line Clearance

1. Inform QA to perform pre-use line clearance.
2. QA will verify:
   • Cleanliness of area and equipment
   • Absence of previous product traces or labels
3. QA to sign the Line Clearance Form (Annexure-2).

5.3 Cleaning After Use

1. Immediately after dispensing activity:
   • Remove all containers and equipment.
   • Wipe down all work surfaces with IPA 70%.
   • Clean floors with detergent solution followed by disinfection.
   • Remove and dispose of waste as per SOP for Waste Management.
2. Check for spills, powder dust, or any residual traces of the materials.
3. Complete and sign the post-use Cleaning Log.

5.4 Frequency of Cleaning

1. Before every dispensing activity (batch-wise).
2. After each dispensing activity.
3. Daily general cleaning at the end of shift.
4. Weekly deep cleaning including ceiling corners and grills.

5.5 Cleaning Material Management

1. Use approved cleaning agents only.
2. Label all cleaning equipment and store in dedicated cupboards.
3. Do not use cleaning tools from other departments in dispensing area.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• IPA: Isopropyl Alcohol

7. Documents

1. Cleaning Logbook (Annexure-1)
2. Line Clearance Form (Annexure-2)

8. References

• 21 CFR Part 211 – Subpart D: Equipment and Facilities
• WHO GMP Guidelines – Pharmaceutical Production

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Logbook

Date	Area Cleaned	Cleaning Agent	Cleaned By	Verified By	Remarks
13/04/2025	Dispensing Table & Balance	IPA 70%	Rajesh Kumar	Sunita Reddy	Clean

Annexure-2: Line Clearance Form

Date	Area	Batch No.	Cleanliness Verified	QA Verified By	Remarks
13/04/2025	Dispensing Area	EA0425-001	Yes	QA Officer	Approved for Use

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
10/01/2022	1.0	Initial SOP Release	New SOP	QA Head
13/04/2025	2.0	Added deep cleaning steps and documentation logs	Audit Preparedness	QA Head