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API Manufacturing: SOP for Storage of Hazardous and Flammable Materials – V 2.0

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API Manufacturing: SOP for Storage of Hazardous and Flammable Materials – V 2.0

Standard Operating Procedure for Storage of Hazardous and Flammable Materials in API Manufacturing

Department API Manufacturing
SOP No. SOP/API/011/2025
Supersedes SOP/API/011/2022
Page No. Page 1 of 11
Issue Date 13/04/2025
Effective Date 15/04/2025
Review Date 13/04/2026

1. Purpose

To define the procedure for safe handling and storage of hazardous and flammable materials used in API manufacturing to minimize risks of fire, explosion, chemical exposure, and ensure compliance with GMP, GHS, and safety regulations.

2. Scope

This SOP applies to all hazardous and flammable chemicals including solvents, acids, bases, and toxic substances received, stored, and handled

within the API manufacturing warehouse and production areas.

3. Responsibilities

  • Warehouse Staff: Ensure proper labeling, segregation, and safe handling practices are followed.
  • Maintenance Team: Maintain fire safety equipment, explosion-proof fixtures, and ventilation systems.
  • Safety Officer: Conduct safety audits, training, and ensure regulatory signage and PPE availability.
See also  API Manufacturing: SOP for Testing of Recovered Solvents for Reuse - V 2.0

4. Accountability

The Warehouse and EHS (Environment, Health, Safety) Managers are jointly accountable for ensuring safe storage, training, and monitoring compliance with hazardous material handling procedures.

5. Procedure

5.1 Classification and Identification

  1. All chemicals shall be classified as per Globally Harmonized System (GHS) and MSDS.
  2. Examples of hazardous materials:
    • Flammable liquids (e.g., Methanol, Acetone)
    • Oxidizers (e.g., Hydrogen Peroxide)
    • Corrosives (e.g., HCl, NaOH)
    • Toxic substances (e.g., Cyanides)
  3. Affix hazard symbols, UN numbers, and handling instructions on each container.

5.2 Storage Requirements

  1. Store flammable materials in flameproof rooms or cabinets as per local fire department regulations.
  2. Segregate incompatible substances based on chemical compatibility chart.
  3. Store acids, bases, and oxidizers separately in ventilated, corrosion-resistant shelves.
  4. Ensure storage areas have:
    • Explosion-proof electrical fixtures
    • Temperature controls
    • Secondary spill containment
    • Proper exhaust ventilation

5.3 Labeling and Signage

  1. Every storage area and container must bear:
    • Hazard classification (e.g., flammable, corrosive)
    • Signal word (e.g., Danger)
    • Pictogram and precautionary statement
  2. Install signage like “No Smoking,” “Flammable Area,” and emergency exit direction boards.
See also  API Manufacturing: SOP for TLC Plate Preparation and Result Interpretation - V 2.0

5.4 Inventory and Monitoring

  1. Maintain updated inventory of hazardous chemicals in the “Hazardous Chemical Register” (Annexure-1).
  2. Conduct physical verification monthly.
  3. Perform routine checks for:
    • Container integrity
    • Label clarity
    • Leakage or spillage
  4. Log temperature and humidity daily for flammable storage areas (Annexure-2).

5.5 Safety Measures and Emergency Equipment

  1. Provide the following safety infrastructure:
    • Fire extinguishers (foam, CO2, dry chemical)
    • Eye wash stations
    • Emergency shower
    • Fire hydrants and smoke detectors
  2. Train staff on:
    • MSDS usage
    • Evacuation procedures
    • Use of fire extinguishers
  3. Conduct mock drills every 6 months.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • MSDS: Material Safety Data Sheet
  • GHS: Globally Harmonized System
  • EHS: Environment, Health, and Safety

7. Documents

  1. Hazardous Chemical Register (Annexure-1)
  2. Temperature and Humidity Log (Annexure-2)
  3. Hazardous Storage Area Audit Checklist (Annexure-3)

8. References

  • OSHA 29 CFR 1910.106 – Flammable Liquids
  • ICH Q7 – GMP Guide for APIs
  • NFPA Codes and IS 2182: Fire Safety Guidelines
See also  API Manufacturing: SOP for Equipment Qualification Protocol Review - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Designation Warehouse Executive EHS Officer QA Manager
Department API Manufacturing Environment, Health & Safety Quality Assurance

11. Annexures

Annexure-1: Hazardous Chemical Register

Date Material Batch Storage Location Classification Quantity
13/04/2025 Acetone AC202504 Flammable Store 1 Flammable 100 L

Annexure-2: Temperature and Humidity Log

Date Time Temp (°C) Humidity (%) Checked By
13/04/2025 09:00 25.1 60

Annexure-3: Hazardous Storage Area Audit Checklist

Date Audit Area Checklist Item Status Corrective Action (if any)
10/04/2025 Solvent Bay Fire Extinguisher Validity OK —

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2022 1.0 Initial SOP GMP Safety Compliance QA Head
13/04/2025 2.0 Integrated GHS and Fire Safety Enhancements Regulatory Update QA Head
API Manufacturing V 2.0 Tags:API batch record, API BMR, API calibration, API centrifuge, API cleaning, API crystallization, API deviation, API documentation, API drying, API equipment cleaning, API filtration, API GMP compliance, API granulation, API hold time, API impurities, API line clearance, API manufacturing, API process, API quality control, API reactor, API sampling, API solvent handling, API validation, API waste disposal, API yield

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Next Post: Capsule: SOP for Recordkeeping for Stability Studies of Capsules – V 2.0

Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Gels V 2.0
  • Injectables V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

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