above (OEB 3, OEB 4, etc.) during raw material receiving, in-process checks, or final sampling in API manufacturing.

3. Responsibilities

• Production Chemist: Execute sampling procedure using defined safety controls.
• QC Analyst: Label, receive, and analyze the samples; review safety data before handling.
• QA Officer: Ensure compliance with PPE protocols, training records, and approve sampling documentation.

4. Accountability

The Production Head is accountable for implementation of the procedure. EHS and QA Heads are jointly accountable for ensuring containment practices and regulatory compliance.

5. Procedure

5.1 Pre-Sampling Preparation

1. Ensure approved Safety Data Sheet (SDS) and classification documents are available for the compound.
2. Check that personnel involved are trained in handling potent and toxic substances and certified for respirator use (if applicable).
3. Verify availability of PPE: full-body suit, nitrile gloves (double), chemical splash goggles, and PAPR (Powered Air Purifying Respirator) or suitable respirator.
4. Ensure the use of:
   • Dispensing booth or isolator (negative pressure)
   • HEPA-filtered exhaust system
   • Antistatic tools and approved sampling scoop

5.2 Sampling Steps

1. Sanitize gloves, isolator port, and sampling tools with 70% IPA before starting.
2. Verify container label, batch number, and material identity before opening.
3. Open container inside the containment system without direct exposure.
4. Using a pre-cleaned sampling device, withdraw the required sample quantity (as per protocol or specification) and transfer to a labeled container.
5. Securely close both primary and secondary containers.
6. Remove the sample through a pass box or transfer hatch using decontamination procedure.

5.3 Sample Labeling and Transfer

1. Label the sample container with:
   • Product/Material Name
   • Batch No.
   • Sampling Date
   • Sampled By
   • Hazard Class (Toxic/Potent)
2. Deliver sample to QC under secure, double-contained conditions.
3. Avoid hand-carrying; use dedicated trolleys with containment enclosures.

5.4 Decontamination and Waste Disposal

1. Wipe down all surfaces using detergent followed by 70% IPA.
2. Dispose of used PPE in red-labeled biohazard bags or designated incineration containers.
3. Log decontamination activity in the cleaning register (Annexure-2).

5.5 Documentation

1. Record sampling event in the Toxic Compound Sampling Log (Annexure-1).
2. Attach a photocopy of the sample label and QA approval slip to the Batch Manufacturing Record (BMR).

6. Abbreviations

• SOP: Standard Operating Procedure
• PPE: Personal Protective Equipment
• QA: Quality Assurance
• QC: Quality Control
• SDS: Safety Data Sheet
• PAPR: Powered Air Purifying Respirator
• BMR: Batch Manufacturing Record

7. Documents

1. Toxic Compound Sampling Log (Annexure-1)
2. Decontamination Record (Annexure-2)
3. Batch Manufacturing Record

8. References

• ICH Q7 – GMP for APIs
• OSHA 1910.1200 – Hazard Communication
• 21 CFR Part 211 – US FDA GMP

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Toxic Compound Sampling Log

Date	Material Name	Batch No.	Sample Qty	Container No.	Sampled By	Remarks
13/04/2025	Compound X	API-20250413	10 g	001		Double contained

Annexure-2: Decontamination Record

Date	Equipment/Area	Cleaned By	Checked By	Remarks
13/04/2025	Sampling Isolator			No residue

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New Toxic Sampling Process	QA Head
13/04/2025	2.0	Added PAPR Use and Decontamination Annexure	Regulatory Compliance	QA Head