Testing According to Pharmacopoeias
It is a legal requirement to test medicines in accordance with pharmacopoeia to ensure they have the required level of pharmaceutical quality. When it comes to checking the quality of relevant substances – raw materials and finished products – CURRENTA Analytics offers you a broad spectrum of techniques for which we have been accredited by AMG as a pharmaceutical testing laboratory.
We are a GMP-certified laboratory that is also registered with the FDA. The analysis covers quality features such as identity, active ingredient content, purity and physical tests.
Our services in the area of pharmacopoeia testing
CURRENTA Analytics has a comprehensive range of equipment, highly qualified staff and an outstanding QA system. This makes us the perfect contract laboratory to take on analytical tasks for all your quality assurance requirements.
We use chromatographic, spectroscopic, elemental analysis, wet chemical and physical techniques to test pharmaceuticals in accordance with all standard pharmacopoeia to ensure high quality:
- European Pharmacopeia
- U.S. Pharmacopeia / National Formulary
- British Pharmacopoeia
- JPE monographs
- Japanese Pharmacopeia
Verifying pharmacopoeia tests
Although analytical methods described in pharmacopoeia are generally deemed to be valid, their suitability for a manufacturer’s specific products often has to be verified.
For instance, a method’s suitability may depend on the analysis equipment and reagents used in the laboratory, but also on the synthesis pathway of an active ingredient or the procedure for producing a finished product. This kind of verification is not a complete revalidation, but does involve identifying selected process parameters that would also be examined during validation.
The scope of a verification is dependent on factors such as the complexity of the analytical method and the product being tested.
We can offer pharmacopoeia test verification as a complete package at your request – from planning right through to the final report. We test and document whether the pharmacopoeia method in our laboratories is suitable for your product. We will work with you to coordinate the scope and procedure of this verification and will gladly offer you well-founded suggestions.
Numerous audits have been conducted on behalf of pharmaceutical companies to verify that our activities comply with GMP requirements (GMP compliance). In our current GMP certificate, you will find an overview of the methods for which we are certified as a pharmaceutical testing laboratory pursuant to § 14 (4) AMG.
Consulting on pharmacopoeia testing
Drug safety and quality take top priority in the pharmaceutical industry. We are happy to use our analytical expertise to offer you advice and support with pharmacopoeia testing. Of course, we can also help you when it comes to analytics for other issues, such as cleaning validation or stability studies.