Imprinting of Solid Oral Dosage Form

How are the conditions of 21 CFR 206 (Imprinting of Solid Oral Dosage Form) met?

FBP Process Scale-Up

How to calculate the cross sectional surface area of fluid bed processor (FBP) for scale up?

azithromycin bcs

Does anyone know the bcs classification of azithromycin .In pharma specialists database it's classified III and IV

Pharmaceutical Development – ICH Q8 (R2)

If we follow ICH Q8 (R2) in a product development phase, can we say the product is developed with QbD approach?

Valsartan + Amlodipine Tablets

Which manufacturing process is best for Valsartan + Amlodipine Tablets?

Biowaiver

What are the requirements for FDA biowaiver?

EU GMP Audit

What are the most critical check points for facing EU GMP audit?

GMP Cheklist

What are the basic GMP requirements for new manufacturing facility?

Most Stringent Regulatory Authorities

Can anyone share the most stringent 10 pharmaceutical regulatory authorities?

QMS Tools

What are the top 5 QMS tools for pharma industry?