Batch release by a Qualified Person in the Pharmaceutical Industry
• 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 has been explained in a deviation report. However, due to number of GMP breaches, you are reluctant to certify the batch. Upon discussion with senior QA executives within the company it is apparent that they will authorise batch release.
• 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?
• Your decision must be based on appropriate risk assessment and backed up by the UK legislation/s in place. The batch was manufactured on 10th July 2021.
• Write a report, detailing your actions with reasons.
• Create a plan of your case report ie create a mind map an figures
• Note: If you use any figures/tables then use appropriate captions and refer them in the text.
• Word limit: 3000 words excluding tables
• GMP Deficiencies*
• The contract sterility test laboratory changed sterility test method from membrane filtration to direct inoculation method.
• No training records found of an operator returning from maternity leave.
