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15 Benefits of Quality Systems in GDP (Good Distribution Practice)

15 Benefits of Quality Systems in GDP

EU GDP Guidelines 2013/C 343/01 introduced the concept of Quality Systems to GDP operations with the overarching aim to maintain product integrity and ultimately the safety of patients.

Chapter 1, Quality Management

1.1. Principle

Wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles in relation to their activities.

As an ISO 9001 QMS Lead Auditor, I have had the opportunity to work with many organisations involved in the distribution of pharmaceutical medicines for humans and often come across Quality Systems that are badly written or comprise of encyclopaedic volumes of documentation when they should be concise and easy to read. This creates a culture with a belief that Quality Systems are bureaucratic and a burden.

Frequently generic Quality Systems are downloaded from the internet and adopted with minor alterations such as a change of address without taking into consideration the size, structure and complexity of the organisations activities.

Ideally bespoke Quality Systems should be developed as all businesses are unique and the organisations strategic objectives and business model needs to be incorporated to achieve maximum benefit.

Correct implementation of a Quality System within a GDP operation does benefit an organisation as it:

  1. Ensures principles of GDP are applied throughout the supply chain
  2. Maintains product integrity and patient safety
  3. Helps achieve consistency
  4. Reduces the risk of falsified medicines entering the supply chain
  5. Reduces distribution complaints
  6. Improves customer confidence
  7. Reduces expensive mistakes
  8. Improves efficiency and lower costs
  9. Reduces wastage
  10. Improves margins
  11. Creates a culture of continual improvement
  12. Increases market share
  13. Involves, motivates and assists in the training of staff
  14. Helps market the organisation effectively
  15. Puts the organisation in a position to exploit new market sectors and territories

Do you have a Quality System in place within your organisation?

Is it implemented?

How do you check its effectiveness?

Worse still, does your organisational Quality System just play a symbolic part as a collection of documents that lie on the top shelf collecting dust?

About the Author:

Zul Mamon
Zul is a Senior Consultant, Pharmacist, ISO 9001 Lead Auditor and GDP Trainer. He has extensive experience in the pharmaceutical sector, having worked for both the independent and national multisite organisations.

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