September 8, 2021: Pharmaceutical Interview Questions and Answers

#StopperringOfFreezeDryingVials #WhatisIntegralVial #RiskOfVialCrimpingInAsepticArea #VisualInspectionOfInjectableProducts

1. Partially stoppered freeze drying vials should be maintained under which grade area?

Partially stoppered freeze drying vials should be maintained under Grade A conditions at all times until the stopper is fully inserted.

2. At which stage of operation, aseptically filled vial cap is considered integral?

The container closure system for aseptically filled vials is not fully integral until the aluminium cap has been crimped into place on the stoppered vial. Crimping of the cap should therefore be performed as soon as possible after stopper insertion.

3. What is the major risk of vial crimping operation in aseptic area? How to mitigate that risk?

The equipment used to crimp vial caps can generate large quantities of non-viable particulates, the equipment should be located at a separate station equipped with adequate air extraction.

4. Vial capping should be done which grade area?

Vial capping can be undertaken as an aseptic process using sterilised caps or as a clean process outside the aseptic core. Where this latter approach is adopted, vials should be protected by Grade A conditions up to the point of leaving the aseptic processing area, and thereafter stoppered vials should be protected with a Grade A air supply until the cap has been crimped.

5. How many filled containers should be visually inspected? Why?

Filled containers of parenteral products should be inspected individually for extraneous contamination or other defects.

6. Explain the process of visual inspection injectable products?

When inspection is done visually, it should be done under suitable and controlled conditions of illumination and background. Operators doing the inspection should pass regular eye-sight checks, with spectacles if worn, and be allowed frequent breaks from inspection. Where other methods of inspection are used, the process should be validated and the performance of the equipment checked at intervals. Results should be recorded.

Reference: EudraLex – The Rules Governing Medicinal Products in the European Union Volume 4, EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 1 – Manufacture of Sterile Medicinal Products – 01 March 2009