Are you a GMP master? Take the Good Manufacturing Practice quiz

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Are you a GMP master? Take the Good Manufacturing Practice quiz

Good Manufacturing Practice Quiz

This Good Manufacturing Practice Quiz stresses the importance of GMP, which is the cornerstone of product quality. Sound GMP knowledge and the application of GMP are the bedrock of compliance. GMP rules in simple terms relies on you to document what you are going to do, do it and then you must document that it has been done.

In the manufacture of medicinal products, not only is Good Manufacturing Practice vital for the production of a quality product, it is essential in meeting regulatory requirements and of course staying in business.

Initial and ongoing training is an investment that protects the interests of your organisation. A proactive GMP training approach helps build capacity and capability. In the world of pharmaceutical manufacturing, we all need to be ‘GMP masters’ of the regulatory guidelines by which we are governed. This Good Manufacturing Practice Quiz may help you decide if you need more training

Most regulatory authorities publish GMP guidelines including the FDAEuropean Medicines Agency (EC), WHO and then some countries like Australia’s TGA use harmonized GMP guidelines from PIC/S (which are almost identical to the EU GMPs), most guidelines share many common concepts.

The European Medicines Agency (EMA) and many of the medicines regulatory authorities of the European Union (EU) Member States are involved in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), a close international cooperation between pharmaceutical inspection authorities in the field of Good Manufacturing Practice (GMP).

PIC/S aims to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of human and veterinary medicines.

It achieves this by:

  • developing and promoting harmonized GMP standards and guidance documents;
  • training national regulatory authorities, particularly GMP inspectors;
  • assessing and re-assessing inspectorates;
  • facilitating cooperation and networking for national regulatory authorities and international organisations.

PIC/S develops and maintains a GMP guide to be used by its participating authorities, which is its main instrument for harmonization. This is equivalent to the EU GMP guidelines in terms of GMP requirements.

Participation in PIC/S is open to any authority with a comparable GMP inspection system it does not have to be identical, i.e. word for word. The US FDA is a PIC/S participating

The Oxford Dictionary defines the word ‘master’ as “having or showing great skill or proficiency”. So how familiar are you with the common concepts of GMP? If you feel you are up to the challenge, test your knowledge by taking the online Good Manufacturing Practice quiz.

Feeling like a little competitive fun? Why not throw down the gauntlet to friends and colleagues to top your score. Share your score on social media, and let the challenge begin.

GMP quiz

If you’ve already tried our Good Manufacturing Practice quiz in the past, we are continually adding new ones to challenge you and your colleagues, you might want to try the updated one!

(5) Comments
  1. 89%. Disagree with set answer for #14 though, the format of reports is something that typically does go into the validation plan.

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