In the medical device industry, internal audits are often viewed primarily as a regulatory requirement. ISO 13485:2016 requires organisations to assess the effectiveness of their Quality Management System (QMS). However, organisations that treat internal auditing purely as a compliance exercise risk missing a significant opportunity.
For more than 35 years, SeerPharma has partnered with organisations involved in the supply, manufacture, and distribution of Medical Devices and In Vitro Diagnostics (IVDs) across the Asia-Pacific region.
Our team supports companies that design, develop, and manufacture medical devices and IVDs across of all classifications, helping ensure their...
Things that you typically look out for when conducting a Good Manufacturing Practice (GMP) supplier or internal audit and typical observations you see during a GMP Inspection.
Self inspection, commonly referred to as an internal audit, is a fundamental part of implementing, maintaining and improving your Pharmaceutical Quality System. Written into the PIC/S Guide to GMP as chapter 9 due to its criticality, Pharmaceutical manufacturers must ensure their self inspection programme is effective.
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