API Manufacturing: SOP for Sampling of Toxic and Potent Compounds – V 2.0

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API Manufacturing: SOP for Sampling of Toxic and Potent Compounds – V 2.0

Standard Operating Procedure for Sampling of Toxic and Potent Compounds in API Manufacturing

Department API Manufacturing
SOP No. SOP/API/097/2025
Supersedes SOP/API/097/2022
Page No. Page 1 of 10
Issue Date 13/04/2025
Effective Date 15/04/2025
Review Date 13/04/2026

1. Purpose

To define a safe, controlled, and GMP-compliant procedure for the sampling of highly potent and/or toxic compounds during API manufacturing using containment equipment and appropriate personal protective equipment (PPE).

2. Scope

This SOP applies to production and QC personnel involved in the sampling of toxic, hazardous, or highly potent materials classified as Category 3 and 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.
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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.
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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
See also  API Manufacturing: SOP for In-Process Filtrate Clarity Testing - V 2.0

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
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