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Quality control standards and pharmacopoeia compliance

Change from ISO compliant to GMP compliant

Question

We'd like to replace reagents used for development with materials for pharmaceutical manufacturing.
Is it possible to make change in quality management system from ISO to GMP?

Answer

We will examine the possibility of changing quality management system.
In order for product to be controlled under GMP, it requires various validation. We will make a proposal after having discussion with customers.

Outcome

We have provided the GMP compliant product after the customer's evaluation of the material.

Compliance with the pharmacopoeias (JP, USP, Ph. Eur.)

Question

Is it possible to supply products that comply with not only the JP but also USP and Ph.Eur.?

Answer

We will examine the possibility of conforming to not only the JP but also USP and Ph.Eur..
We will also consider the compatibility with other pharmacopoeias such as ChP, and for additional tests such as endotoxin tests.

Outcome

We supplied a product comply with USP and Ph.Eur addition to JP, and supplied products with adding endotoxin test in the specification.