Fabrication

Manufacturing

Our manufacturing plant in Jejuri, near Pune in Maharashtra is spread over a sprawling 8000 square metres. Our facility is built to adhere to the most stringent operating procedures of cGMP in conformity with national and international standards.  We use state of the art technology, a highly motivated and technically competent team, highest standards of safety practices and environmentally green and clean processes.  The facility is equipped with sophisticated machinery to achieve a high level of accuracy and precision.

Shalina Distrubution

About the facility

The manufacturing plant is a 100% Export Oriented Unit and has been designed to accommodate rapid future expansion.  It currently has a capacity of 2.5 billion tablets, 1.25 billion capsules, 150 million tubes of cream and 40 million bottles of ointment. The Jejuri site map is designed and constructed as per Schedule-M & WHO-GMP norms. All the dosage forms have dedicated core areas and are well equipped with required utilities to meet cGMP norms. The entire production facility is equipped with efficient Air Handling Units (AHUs). All core manufacturing areas are under pressure differential and appropriate air locks to avoid cross contamination. There is Adequate storage area for Raw material, Packaging materials and Finished products.

Regulatory Approvals

Our factory has been certified by:

  • NAFDAC – Nigeria
  • FDA – Ghana
  • PPB – Kenya
  • MOH – DRC
  • MOH – Ivory Coast
  • MOH – Zambia

ISO 9001 : 2008

Quality Assurance

Our QA professionals are responsible for developing, monitoring and overseeing measures that assure control, reproducibility and reliability of our manufacturing and testing processes. Through their activities, the QA team is responsible for ensuring that Shalina meets government requirements as well as providing assurance of safety and efficacy of medicines to the consumers.

Quality Control

Our QC professionals are concerned with activities related to the correct receipt, handling, packing and internal control and release of products. These activities must be carried out prior to the shipment of goods. Shalina’s QC team ensures that every single batch is released from our facilities only after the necessary controls have been adhered to.

Vendor Qualification and Management

Shalina Healthcare procures only from suppliers who have been pre-qualified by our Quality professionals. Our prequalification process falls into three major steps:

  • Screening of Supplier Documentation
  • Assessment and Sample Analysis
  • On-Site Audit

Our quality promise

We ensure that products manufactured and distributed by us, consistently meet predetermined quality specifications and our customer expectations. We stand committed to strictly comply with current Good Manufacturing Practices (cGMP) in conformance with national and international standards. We believe in continual improvement of our products and processes through training, innovation and active involvement of our employees.

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