Sourcing

Shalina Healthcare procures only from suppliers who have been prequalified by our QA/QC departments in India and China. Our prequalification process consists of three stages, after which a periodic evaluation of approved suppliers is undertaken as part of continuous review and improvement systems.

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.

Screening of Supplier Documentation

A detailed questionnaire is shared with short-listed suppliers. This covers many details related to the facility, man-material flow, regulatory approvals, water systems, air handling systems, quality management systems.

Assessment and Sample Analysis

Our inspection pharmacists evaluate the content of the potential supplier’s Site Master File as well as certificates, licences and the completed manufacturer questionnaire. We focus on the flow of the production, ground plans, technical drawings as well as water systems and ventilation. Suppliers who are unable to fill in the questionnaire OR not found satisfactory during our evaluation are dropped from selection.

On-site Audit

In order to ensure that new as well as existing manufacturers comply with our standards, it is fundamental that our QA team performs on-site audits. Each audit is conducted according to a checklist based on the WHO GMP guidelines and in accordance with our written SOPs. A detailed inspection report is prepared by our inspection team who recommends whether to pre-qualify or reject the supplier due to an unacceptable level of GMP compliance.

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.