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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.
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.
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