FAQ

Particle Analytical – Frequently Asked Questions

From GMP and Hauser ratio to sample submission. And more.

Particle Analytical is aimed to provide you with valuable information. Whether you have questions about a Quality approach, Scientific definitions or simply need practical information, e.g. for the sample delivery – take a second to browse through the FAQ section. 

In order to secure a smooth sample registration process, please fill the Sample Submission Form and add it to the sample delivery. Besides the necessary sample information, we need to get the Material Safety Data Sheet for the Material in order to evaluate the safety for the lab technicians. For any questions rearding your sample delivery, please feel free to get in touch.

If you are interested in getting a quote, please fill in our quote form, and we will get back to you with a concrete quote for your request. It’s free to get a quote.

If you are not yet ready for getting a quote, give us a call or send us an email, so we can help you finding the best way forward.

We are proud of our GMP (Good Manufacturing Practice) certification. If you are interested in seeing our certificate, for all EU-European companies, you can find GMP certficates in the database EudraGMDP, where it’s free to download.

It is GMP requirement to have method validated before product release. 

 

It recommended to have a method for each product.

In the ICH guidelines, several references to determination of particle sizes are found (e.g. ICH Q6A, Q8 & Q9). Please visit our section on ICH guidelines to get more insight.

The European Pharmacopoeia (Ph. Eur.) is a legally binding collection of quality standards for medicines used in Europe. Every 3 years it is updated by the European Pharmacopoeia Commission.

The European Pharmacopoeia covers the quality and purity requirements for active substances, excipients, and medicinal products, as well as analytical methods for their testing. Pharmaceutical manufacturers, regulatory authorities, and laboratories across Europe, reference the European Pharmacopoeia to ensure compliance with quality standards. 

Yes, Particle Analytical is following the guidelines according to European Pharmacopeia. We are GMP certified and FDA approved.

If a result is out of of specification (OOS), we are from a legally perspective  obliged to investigate internally. The purpose of the internal investigation is to find the root cause – was it an laboratory error or was it maybe the sample condition who lead to rsult out of specification?

If an OOS occurs, the Particle Analytical team follows the following procedure:
Quality Control informs the customer

  • QC opens an internal OOS investigation
  • QC & the responsible technical specialist do lab investigation
  • QA finally approved the OOS report
  • Customer received per e-mail as pdf the OOS report and the Certificate of Analysis
  • Customer decides, if a reanalysis shall be carried out 

The customer will receice the Certificate of Analyses and the outcome of the OOS as pdf by E-Mail. Any additional anaylses on the OOS – sample is an individual customer decision. 

Yes, customer can choose if they prefer a remote audit or an On-Site – Audit. As an audit is requires additional QA ressources,  laboratory and QC time we will charge the customer for an Audit.  

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Knowledge Hub

Explore our Knowledge Hub for regulatory guidelines, publications and events. Find also answers on frequently asked questions.

How we can help

We can find the root cause for problems in development or manufacturing processes. Our experts will listen to your need and offer tailored solutions.

Why choose us

By choosing Particle Analytical, you chose highest quality standard. We are a GMP certified contract laboratory, specialised in pharmaceutical drug development and manufacturing testing.