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GMP Insiders Expert Team
The GMP Insiders Expert Team is a group of seasoned professionals specializing in quality assurance, regulatory compliance, and operational innovation in pharmaceutical and biotech manufacturing. United by a passion for advancing Good Manufacturing Practices, they transform complex compliance challenges into clear, actionable strategies that drive operational excellence.
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Latest GMP Posts
Overview of ISO 5 cleanroom standards, airflow control, monitoring requirements, and qualification steps under ISO 14644-1
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USP–NF PF 51(6) draft updates modernize analytical validation, ophthalmic standards, leachables guidance, and radiopharmaceutical practices.
Qualification vs. Validation explained for GMP professionals — clear regulatory differences, lifecycle expectations, and real-world applications across pharma systems.
A technical comparison of wet and dry granulation techniques with focus on process control, scalability, PAT tools, and continuous manufacturing readiness.
