Blog Post
Managing Inspections without Stress: Coordinate Responses Flawlessly
When it comes to being prepared for an inspection from a regulatory authority, the combination of preparation and practice will often make the difference between...
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Blog Post
FDA Approves Emergency IND in Less Than Three Hours
How a CAI agent helped make a difference (more…)
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Blog Post
E-Pub: The Importance of Annex 1
Annex 1 - "Manufacture of Sterile Medicinal Products." was first published in 1971. However, the first revision since then is currently in process. And this...
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Blog Post
Implementing USP Visual Inspection Requirements
The word “visible” in the expression, Visual Inspection of Parenteral Products, has no meaning unless the viewing conditions are specified. (more…)
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