Pharmaceutical analytical control

Faced with the growing demands of hospital pharmacy, where risk management is central, analytical control has become the pillar of safe and compliant dispensing.

The QCRx® analytical control offers you a complete analysis of your chemotherapeutic preparations in just a few minutes. This gives you the certainty that your bag perfectly matches the prescription, while protecting your patients. It is applicable for hospital preparations, as well as compounding.

What is analytical control in pharmacy?

These techniques confirm the identity of active substances and the compliance of critical excipients before any batch release, thus guaranteeing the reliability of the drug circuit.
The ANSM’s 2023 GPP guide specifies that “no preparation is released and dispensed before the radiopharmacist in charge of this release has certified that it meets the specifications established in the preparation file”; each phase (formulation, control, release) must therefore receive a documentary visa from the pharmacist in charge.

Each step includes the management of results from quality control and physicochemical analyses.

Why is pharmaceutical analysis crucial?

A systematic pharmaceutical analysis is required by Good Preparation Practices 2023: “The decision to make or have these preparations made is taken after pharmaceutical analysis and in compliance with the CSP.”

The validation of analytical methods, described in ICH Q2(R2), must demonstrate that the procedure is “fit for purpose” for batch release and stability testing, thus ensuring the shelf life and quality of the finished product.

The clinical literature points out that dosage, dilution, and labeling errors are among the major causes of adverse drug events; their incidence decreases significantly when analytical control precedes dispensing.

The strengthening of labeling, considered an essential step in preventing dosage errors in compounding pharmacies, is an integral part of this control.

Finally, implementing a deviation management system coupled with staff training reduces rework and improves the overall efficiency of the release flow.

In practice, this rigorous analysis allows:

  • To limit errors in dosage, dilution, or labeling;
  • To protect patients by immediately detecting any non-compliance;
  • To optimize your workflows: fewer reworks, more peace of mind thanks to training (video or in-person) focused on managing discrepancies.

See the QCRx® in action.

Schedule an online demonstration:
REGISTER

Meet European standards, effortlessly

In an environment where pharmaceutical quality is measured by compliance with the strictest standards, your control method must naturally align with:

  • GMP / GMP: Good Manufacturing Practices, guaranteeing a robust process;
  • ISO 9001 and ISO 13485: quality management and medical devices;
  • GPP 2023: Good Preparation Practices, specifically strengthened for PUIs;
  • ANSM: French traceability and batch release requirements;
  • EMA: European directives harmonizing risk assessment.

To learn more about how to integrate these standards without burdening your processes, visit our page Quality Assurance and Compliance.

QCRx® Technology: UV-VIS/Raman spectrometry for precision

To meet these standards, Icones Services has developed the QCRx®. This solution combines robotics and UV-VIS/Raman spectrometry to control the quality, quantity, and solvent of your preparations in less than 70 seconds. You get an objective, traceable, and immediately usable reading.

Control process: before, during, after preparation

Let’s see how this technology fits into your daily routine. QCRx® intervenes at every step to secure the chain:
  1. Before: Calibration and validation of analytical methods in accordance with ISO 13485;
  2. During: Applied by technicians holding a professional license in the pharmaceutical industry trained in GPP practices;
  3. After: Results management and archiving meeting quality and environmental requirements.

Concrete applications

QCRx® controls your finished products and adapts to a wide spectrum of pharmaceutical products: chemotherapies, eye drops, parenteral nutrition, injectable solutions, monoclonal antibodies, diluted capsules, etc. This gives your team a cross-functional tool suitable for all production units.

Benefits for your hospital pharmacy

  • Release time savings: 30 heterogeneous preparations are released in 35 minutes, twice as fast as FIA (1 hour) and nearly four hours earlier than routine UHPLC.
  • Operator load reduced by a factor of six compared to gravimetry: staff are confined for only 7 minutes 30 seconds; the rest of the time they can return to the preparation room or make logistical adjustments.
  • Zero interpretation & zero re-entry: QCRx pushes the results directly into the prescription software, whereas other methods require human analysis and re-entry for archiving.
  • 3-in-1 control: QCRx checks the quality, quantity, and solvent of the preparation, then archives the results automatically. PUI Versatility: Even conjugated antibodies or opaque preparations (nutrition, eye drops) can be passed through the same line without changing the protocol.

See the QCRx® in action.

Schedule an online demonstration:
REGISTER