September 4, 2021: Pharmaceutical Interview Questions and Answers

#MethodOfChoiceForSterilization #PeriodicSterilization #Labeling #TemperatureDuringSterilizationProcess #ImportanceOfPhysicalMeasurementsDuringSterilization

1. What should be the method of choice for sterilization as per EU Annex-1?

Where possible, heat sterilisation is the method of choice.

2. What should be the verification schedule for sterilization process?

The validity of the sterilization process should be verified at scheduled intervals, at least annually, and whenever significant modifications have been made to the equipment.

3. How to differentiate products which have not been sterilised from those which have?

Each basket, tray or other carrier of products or components should be clearly labelled with the material name, its batch number and an indication of whether or not it has been sterilised. Indicators such as autoclave tape may be used, where appropriate, to indicate whether or not a batch (or sub-batch) has passed through a sterilisation process, but they do not give a reliable indication that the lot is, in fact, sterile.

4. How to ensure temperature during sterilization process?

Each heat sterilisation cycle should be recorded on a time/temperature chart with a sufficiently large scale or by other appropriate equipment with suitable accuracy and precision. The position of the temperature probes used for controlling and/or recording should have been determined during the validation, and where applicable also checked against a second independent temperature probe located at the same position.

5. Can chemical or biological indicator be replacement of physical measurements during sterilization cycle?

Chemical or biological indicators should not take the place of physical measurements.

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

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