Safety Audit for Pharma Industry, India

Last updated: May 20, 2025

Overview

IFluids Engineering conducted a Safety audit, with a focus on ensuring safe, sustainable, and compliant operations. The audits were conducted in alignment with major national regulations such as the Factories Act, Environment Protection Act, Hazardous Waste Rules, and standards including IBR and OISD by Electrical, mechanical, civil, and Safety auditors. Critical equipment like boilers, effluent treatment plants, solvent recovery units, and fire safety systems was thoroughly reviewed.

Audit Methodology

  • Pre-Audit Preparation
  • Opening Meeting
  • Field Inspection and Walkthrough
  • Interviews and Stakeholder Interaction
  • Document and Records Review
  • Gap Analysis and Risk Rating
  • Report Preparation
  • Close-out meeting

For detailed methodology, visit- Safety Audit for Refineries

Codes and Standards Referenced

The audit was carried out in line with several national and international benchmarks mentioned below:

  • ISO 14001:2015 – Environmental Management Systems standard.
  • ISO 45001:2018 – Occupational Health and Safety Management Systems standard.
  • Environment (Protection) Act, 1986
  • Factories Act, 1948
  • Air Act, 1981, Water Act, 1974
  • Hazardous Wastes Rules, 2016
  • MSIHC Rules, 1989
  • Petroleum Act, 1934 and Rules
  • The Boilers Act, 1923
  • The Gas Cylinders Rules, 2016
  • National Building Code (NBC) of India

Conclusion

The successful completion of these audits underscores the organization’s commitment to operational excellence and sustainable industrial practices. The assessments highlighted areas of strength, including the presence of basic environmental controls and safety measures, while also identifying critical gaps in hazardous material handling, fire safety infrastructure, and documentation protocols. These findings guided continuous improvement efforts and fostered a culture of proactive safety management.

1. Safety Audit for Anjan Drug Private Limited, Unit-II, SIPCOT Industrial Estate, Gummudipoondi, and Anjan Drug Private Limited, Unit-I, SIDCO Pharmaceutical Industrial Estate, Alathur

A Safety audit was successfully conducted at Anjan Drug Private Limited’s manufacturing units located in SIPCOT Industrial Park, Gummidipoondi, and Alathur, Tamil Nadu. The audit aimed to assess compliance with applicable statutory EHS regulations, internal corporate standards, and relevant industry best practices. The evaluation covered key areas such as air and water pollution control, hazardous waste management, fire safety protocols, and occupational health standards. The audit process included on-site inspections, a thorough review of relevant documentation, and interactions with plant personnel to ensure an accurate and practical understanding of existing systems and procedures.

The audit identified several areas of good practice, along with opportunities for improvement. Constructive recommendations were provided to help the facilities address compliance gaps and further strengthen their EHS (Environmental, Health, and Safety) performance. With the successful completion of this audit, Anjan Drug Private Limited has reaffirmed its commitment to environmental stewardship, workplace safety, and continuous improvement. The findings and recommendations serve as a valuable resource for guiding future enhancements and aligning operations more closely with regulatory expectations and corporate sustainability goals.

Project Insights

  • The assessment covered the existing state of the infrastructure at the site, which included civil infrastructure, structural elements, and all load-bearing elements, roofing structures, stairways, etc.
  • Process safety was assessed, including handling of product, firefighting systems, and the storage and handling of toxic and corrosive chemicals.
  • The adequacy of the existing ventilation and extraction systems for general ventilation, product filling, and packing was checked.
  • The existing state of infrastructure at the site for handling spillages and leaks, including containment and bunding, drainage within the plant, and firewater retention, was also assessed.
  • The status of the electrical installation at the facility, including the standard of electrical safety of wiring, panels, switchgear, MCC panel room, and its emergency exits, was reviewed.
  • General Environment, Health & Safety systems on site, including management structure, roles and responsibilities, delegation of duties, and the systems for ensuring the safety of personnel handling toxic and corrosive chemicals, were examined.
  • Noise assessment and control were conducted.
  • Emissions to the atmosphere and their control measures were evaluated.
  • Effluent discharge and treatment systems were reviewed.
  • Solid and hazardous waste management practices were assessed.
  • Emergency response facilities and systems were examined.
  • Accident investigation and reporting procedures were reviewed.
  • The installation of electrical fittings as per the zoning classification was checked.
  • Solvent and chemical storage were assessed.
  • Open and closed yard storage of toxic and corrosive materials was inspected.
  • The safety training program on-site was reviewed.
  • The movement of trucks for loading and unloading, and the existing facilities for loading and unloading of raw materials and finished goods, were evaluated.

Deliverables

Detailed Audit Report of EHS management system that includes key observations and recommendations, action plan professional insights aligned with statutory requirements such as the Factories Act, IS 14489, and relevant best practices, annexures and supporting documentation consisting of audit checklists and inspection formats, Statutory compliance records and permits, Calibration certificates, training documentation and list of interviewed personnel was submitted