Ensuring product safety, efficacy and regulatory compliance hinges on maintaining the integrity of the pharmaceutical supply chain. GDP Auditing Services (Good Distribution Practice) are crucial in safeguarding this intricate network by mitigating risks and bolstering quality assurance.
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Ensuring regulatory compliance is essential in the pharmaceutical and biotechnology industries. These industries deliver safe, effective and high-quality products to patients worldwide.
Adherence to Good Manufacturing Practices (GMP) forms the foundation of this commitment, governin…
Data Integrity is a concept and process that is integral to the business of manufacturing and distribution of medicinal products. It is a practice that must be followed by every employee within the workplace. We learn through our mistakes, and we develop strategies and ways of thinking that i…
Inglasia Pharma Solutions is a Global GMP consultancy serving the pharmaceutical and biotechnology industry.
We have expertise in US FDA, EMA, UK MHRA and World Health Organisation standards on Good Manufacturing Practice. Since 2011, we have been supporting Global medicines manufacturers in …
This free training video on Good Distribution Practice is based on EU GDP 2013/C 343/01 guidelines and World Health Organisation, Technical Report Series 1025 – Annex 7: Good storage and distribution practices for medical products.
This short, but succinct, video explains why there is t…
Departments and external stakeholders must work together to expedite recalls
The above process overview highlights the main considerations when executing a medicinal product recall. When a notification of a recall is received by the MAH (marketing authorisation holder in Country for the medici…
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