API Manufacturing

Quality & Regulations

Quality Policy

Arch Pharmalabs Limited is dedicated to achieving total customer satisfaction and confidence through continuous improvement of its Quality Management Systems and full compliance with all applicable statutory and regulatory requirements. This responsibility and commitment is led, practiced and communicated by an independent Corporate Quality Assurance department reporting directly to the Company's Chairman and Managing Director.

Key responsibilities include:

  • Ensuring full compliance with cGMP, ICH Q7A, ISO, pharmacopoeial requirements and other industry standards that are clearly understood and implemented by Company staff
  • Establishing and pursuing quality objectives and performance standards
  • Reviewing suitability of quality policies to ensure compliance with current guidelines and providing adequate resources to management in achievement thereof

Inspection & Compliance Certificates

Particulars Gurgaon unit Medak unit 3 (Sibra) Tarapur Oncology unit Dombivli unit
Quality Certifications
cGMP Compliant Compliant Compliant Compliant
Inspected / Accredited USFDA Inspected USFDA Inspected USFDA Inspected & EDQM INSPECTED
Drug Master Files 4 USDMFs / 3 CEPs 4 USDMFs / 2 CEPs 6 USDMFs / 6 CEPs
ISO 9001
ISO 14001
OHSAS 18001:2007

Environment, Health & Safety (EHS)

We are committed to the safety and health of our employees, sub-contractors and visitors and care of the environment and the prevention of accidents, health hazards and pollution. Our Company ensures that all the activities and services carried out and products are manufactured considering appropriate Environmental, Health and Safety risks, aspects, impacts and objectives and in conformance with the relevant legal requirements. All levels of management and all employees have a primary responsibility for the safety and well-being of all employees, subcontractors and visitors and prevention of pollution.

EHS Objectives:

Identify and update systems for the safety, health & environmental hazards and risks associated with our activities and products.

  • To categorize high risk areas and improve conditions for enhanced safety
  • To improve conditions in order to prevent accidents, health hazards and pollution
  • To minimize waste generation, promote recycling and green chemistry
  • To reduce energy consumption
  • To reduce harmful emissions
  • To create safety awareness to our suppliers and customers
  • To the best extent possible, to work with suppliers who themselves have sound safety, health and environmental policies
  • To set Environmental, Health & Safety objectives and targets by all departments to improve EHS performance
  • To implement and continually improve an Integrated Environmental, Health & Safety Management System which conforms to the latest requirements of ISO 14001 and OHSAS 18001

We have incorporated following EHS measures:

  • Full-fledged effluent treatment plants on all facilities
  • Solid Waste Management Systems
  • Solvent Recycling
  • Water Treatment Facilities

Our Company’s investment in reverse osmosis plants is proof for its commitment to exemplary EHS practices. We have established solvent recovery processes in place. Our effluent treatment plants have both aerobic and anaerobic treatment facilities. We are required to obtain consents from the State Pollution Control Board to establish and operate our facilities and to comply with their conditions regarding emissions and discharge of effluents in air and water. The employees are educated and trained to improve their awareness and skills.

We have received OHSAS 18001:2007 for our Medak Unit 1, Dombivli and Gurgaon Unit. We have also been honored with the National Safety Award by the Ministry of Labour & Employment for our Gurgaon Unit in the year 2006 in recognition of our team efforts for continual improvement in the field of Safety, Health and Environment.