critical to prevent contamination, ensure sample integrity, and maintain compliance with Good Laboratory Practices (GLP) and GMP requirements.

2. Scope

This SOP applies to all personnel responsible for sample preparation and cleaning in the AMD laboratory for both active pharmaceutical ingredients (APIs) and formulated products.

3. Responsibilities

• Analytical Chemists: Perform cleaning as per schedule and record activities.
• Housekeeping Staff: Conduct general cleaning as per facility SOPs.
• QA Department: Verify cleaning logs and ensure compliance.
• AMD Supervisor: Ensure implementation and adherence to the SOP.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring that the cleaning procedures for sample preparation areas are correctly followed and documented.

5. Procedure

5.1 Cleaning Frequency

1. Daily Cleaning: Performed at the end of each working shift.
2. Weekly Cleaning: Includes equipment surfaces, drawers, and undersides of workstations.
3. Monthly Cleaning: Full deep cleaning of floors, ceilings, light fixtures, exhaust vents, and walls.

5.2 Cleaning Materials

• 70% IPA (Isopropyl Alcohol)
• Lint-free cloth or sterile wipes
• Vacuum cleaner with HEPA filter
• Disinfectant solution (approved grade)
• Dedicated mop and buckets (labeled ‘Analytical Area’)

5.3 Cleaning Steps

1. Wear appropriate PPE including gloves, mask, and lab coat.
2. Remove any test samples, chemicals, or glassware from benches.
3. Dust surfaces using a clean, dry lint-free cloth.
4. Clean workbenches and drawers using 70% IPA.
5. Use separate cloths for different zones (e.g., chemical storage, weighing areas).
6. Vacuum the floor and wipe with a damp mop using disinfectant.
7. Inspect the sink area and clean using appropriate detergent and water.
8. Dispose of used wipes and cloths in the designated biohazard bins.

5.4 Area Segregation

• Cleaning tools used in the sample preparation area must not be used elsewhere.
• Store mops and cleaning materials in a dedicated ‘AMD Cleaning Store’.

5.5 Documentation

1. Record cleaning activity in the Sample Preparation Area Cleaning Log (Annexure-1).
2. Indicate the date, time, personnel name, and signature for each cleaning activity.
3. Any deviation or failure to clean as per schedule must be documented in Annexure-2.

6. Abbreviations

• AMD: Analytical Method Development
• IPA: Isopropyl Alcohol
• PPE: Personal Protective Equipment
• GLP: Good Laboratory Practice

7. Documents

1. Annexure-1: Sample Preparation Area Cleaning Log
2. Annexure-2: Deviation Log

8. References

• WHO TRS 986, Annex 2 – GMP Guidelines for Pharmaceutical Products
• ICH Q7 – Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – GMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Sonal Deshmukh	Ravi Khanna	Dr. Neeta Joshi
Designation	Analyst	QA Reviewer	Head – AMD
Department	Analytical Method Development	Quality Assurance	Analytical Method Development

11. Annexures

Annexure-1: Sample Preparation Area Cleaning Log

Date	Time	Area Cleaned	Performed By	Verified By
01/06/2025	18:00	Workbenches & Floor	Sonal Deshmukh	Ravi Khanna

Annexure-2: Deviation Log

Deviation ID	Description	Corrective Action	Follow-up
DEV/AMD/334/01	Missed Weekly Cleaning	Rescheduled next day, documented	QA Verified

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2025	2.0	Updated cleaning checklist and annexures	Annual SOP review	Dr. Neeta Joshi
10/04/2022	1.0	Initial version released	New SOP	QA Head