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?Write a report, detailing your actions with reasons.
Description Law and Admin (Case Report) • 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 […]