Drug manufacturing audits are crucial for ensuring pharmaceutical and biotech companies meet quality assurance and regulatory compliance standards. These audits verify adherence to GMP and GDP and identify areas for improvement. For success in the highly regulated industry, proper audit prepa…
A single lab mistake can result in regulatory penalties, delayed product launches or loss of trust. Good Laboratory Practices (GLP) ensure regulatory compliance, patient safety and research integrity. Beyond following rules, GLP helps build a reputation for precision, excellence and accountab…
In pharmaceuticals, ensuring product safety, efficacy and consistency is critical. Every medication must undergo rigorous scrutiny to meet the highest standards. Pharmaceutical validation processes are the key mechanisms that uphold these standards and without them, companies risk compromisin…
The pharmaceutical and biotech industries have one thing in common: a relentless commitment to safety and quality. Maintaining GMP compliance is a regulatory requirement and a moral obligation to ensure the safety and efficacy of your products. Yet, despite its importance, many companies stru…
In comparison with the Federal Decree-Law n8 of 2019, distribution reporting is being reinforced, with notable expansions of scopes, responsibilities and introduction of strict timelines. A national database for reporting counterfeit has been also introduced in an effort to fight such illegal…
Everyone working within the industry must accept the need for a structured and documented change management process. They must first realise the benefits of having a defined change control process, to be able to effectively manage changes that impact on the medicinal products. This is a mindset …
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