[Ashiqur]

What are the most critical check points for facing EU GMP audit?

[aid]

Hi Ashiqur!
Here is the top 10 check points for facing EU GMP audit:

1. Job Training
2. Quality Policy
3. Good Housekeeping Program
4. Equipment Qualification and Calibration Program
5. Cleaning Validation
6. Test specification and control
7. Inventory and Vendor Control Program
8. Process Validation Program
9. Reprocessing/ Reworking Procedure
10. Complaint Handling and Customer Satisfaction Program

The above list is not complete but will be important for audit preparation.

[FRD]

Is it sufficient to get approval from any EU members for whole EU market?

[Pharma Digests]

In the European Union (EU), there are two main routes for authorising medicines: a centralised route and a national route.

Under the centralised authorisation procedure, pharmaceutical companies submit a single marketing authorisation application to EMA.

This allows the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation.

EMA’s Committee for Medicinal products for Human Use (CHMP) or Committee for Medicinal products
for Veterinary Use (CVMP) carry out a scientific assessment of the application and give a recommendation on whether the medicine should be marketed or not.

Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States as well as in the EEA countries Iceland, Liechtenstein and Norway.

If a company wishes to request marketing authorisation in several EU Member States for a medicine that is outside the scope of the centralised procedure, it may use one of the following routes:
– the mutual-recognition procedure, whereby a marketing authorisation granted in one Member State can be recognised in other EU countries;
– the decentralised procedure, whereby a medicine that has not yet been authorised in the EU can be simultaneously authorised in several EU Member States.

[FRD]

Are EU and FDA GMP audits similar?

[Pharma Digests]

Both the EU and the FDA aim to ensure that pharmaceutical products meet the highest standards of quality, safety, and efficacy, thereby protecting public health. However, there are some differences in their regulatory frameworks, focus areas, and inspection processes.

Such as, EU strongly emphasis on quality risk management (ICH Q9) and quality systems but FDA strongly focus on data integrity, process validation, and compliance history.

[Author]

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