Determine what actions, information, and data will be necessary (for each deficiency) in order for you, as the responsible Qualified Person, to carry out the Batch disposition?
You are Qualified Person at PQR Pharma, UK. During Review of a batch of a pre – filled syringe product, you noticed numerous GMP deficiencies* during the manufacturing and packaging operation. You are the only manufacturer of this product which is in the essential medicines list (for neonatal meningitis patients). Each GMP breach in itself […]