Pharmaceutical preparation
The pharmaceutical preparation begins with the taking of a medical prescription (Rx), which serves as a personalized roadmap within an internal use pharmacy (PUI) for patients with chronic or acute illnesses.
At the heart of a hospital pharmacy service, good pharmaceutical preparation helps guarantee the safety of patient care by eliminating any risk to their health and administering quality medications, adapted to each pathology.
Each pharmacist, in direct contact with the prescriber, rigorously selects the substances and controls the dosages according to the pharmacopoeia and public health standards. Whether they are magistral injectable preparations, in capsules, in ointment or other products derived from hospital preparations, these formulas respond to a broad therapeutic spectrum of diseases, from the most common to the rarest, thanks to harmonized protocols.
Definition and distinctions
According to the European Pharmacopoeia, pharmaceutical preparation includes all the formulas intended to manufacture a drug for a specific therapeutic use. We distinguish:
- Magistral preparations: extemporaneous formulas, customized by the pharmacist and validated by the physician to treat a specific condition.
- Hospital preparations: prepared in PUI (Personal Intensive Care Unit) to meet the most common needs.
- Manufactured pharmaceutical specialties, reimbursable and validated by the ANSM, compliant with the pharmacopoeia.
- Sterile and non-sterile products, from tablets to injectable solutions, available to treat numerous conditions.
These hospital preparations, listed in the National Formulary or produced in the absence of equivalent specialties, also include certain sterile medical devices, such as capsules, acid solutions or sterile ointments, depending on clinical needs.
Learn how QCRx® controls your pharmaceuticals in less than 70 seconds.
Challenges for the pharmacist
The hospital pharmacist faces major challenges on a daily basis: he must first ensure compliance with the standards and best practices defined by the ANSM and the pharmacopoeia, while coordinating his teams of preparers, interns and hospital stakeholders.
In particular, it manages the timing and release times of parenteral bags, to remain responsive as soon as a therapeutic emergency is taken care of.
Under heavy pressure and often understaffed, it must maintain a high level of quality and traceability, even in critical situations. It is precisely to meet these challenges and optimize productivity that the QCRx® system was developed, automating control without sampling and drastically reducing preparation times.
Finally, as guarantor of Good Pharmaceutical Practices (GPP) for preparations, the ordering hospital pharmacist must also trace the costs for Health Insurance.
Specificities of PUI preparation
In PUI (Internal Use Pharmacy), pharmaceutical preparation is particularly rigorous: the pharmacist works closely with the clinical physician to adapt each dosage according to the patient’s condition and illness. In particular, he ensures the quality of raw materials and the secure storage of poisonous substances within the internal use pharmacy.
The challenge is to ensure the safe use of medicines, without unnecessary delay.
Every step, from the receipt of substances to their release, must be tracked. This ensures patients benefit from consistent quality and optimal use of hospital preparations. Communication between healthcare services, pharmacies, and physicians is essential for adjusting protocols in real time and securing the treatment pathway.
Procedures and best practices
Patient safety depends on the rigor applied to each product. From the moment a doctor prescribes the product, the pharmacist checks for compliance with health and safety standards. Raw materials and excipients are weighed precisely, ensuring the absence of any contamination.
An interim analysis checks the pH, concentration, and absence of particles. Quality assurance validates each preparation before release to the department, for immediate use with the patient.
- Verification of the prescription (Rx) and validation by the pharmacist.
- Selection of raw materials and excipients, rigorous weighing.
- Preparation in a controlled environment, observance of pH and addition of acid if necessary.
- Final analysis and visual inspection to ensure the absence of any contamination.
- Packaging in solution or capsules and release after ANSM authorization.
- Archiving of the checklist and traceability of each preparation.
This procedure, which complies with the European Pharmacopoeia for both reimbursable and non-reimbursable preparations, guarantees the rigorous application of Good Pharmaceutical Practices (GPP). It governs each stage of hospital preparations, from the selection of raw materials for pharmaceutical use to the final packaging of the medicines.
Regulatory and legislative framework
European Directive 2003/94/EC and ANSM requirements define the standards for all pharmaceutical preparations. Marketing authorization is required for each specialty and each medication.
The principles of quality assurance and traceability guarantee the absence of any iatrogenic risk linked to a disease. Resources are available to support pharmacists in the proper use of hospital preparations.
- Release authorization signed by the responsible pharmacist.
- Quality assurance and traceability of materials and substances.
- Compliance with good manufacturing practices and European standards.
- Proof of the absence of contaminants that could aggravate illnesses.
- Monitoring of the use and administration of hospital preparations.
Coverage by the French Health Insurance for hospital preparations, in the absence of equivalent pharmaceutical specialties available on the market, is subject to strict conditions. This includes compliance with Good Preparation Practices (GPP) as well as manufacturing standards established by European legislation and the French National Agency for the Safety of Medicines and Health Products (ANSM).
These requirements aim to guarantee the quality, safety and efficacy of medicines prepared in in-house pharmacies (PUI).
QCRx®: innovation and analytical control
- Quick control and release after authorization.
- Automatic archiving of the fulfillment list.
- Intuitive interface for pharmacists and healthcare teams.
- Compliance with ANSM standards and the pharmacopoeia.
Training, digitalization and perspectives with QCRx®
To support pharmacists and technicians in achieving ever-increasing safety and performance, Icônes Services offers training modules 100% dedicated to QCRx®. These interactive sessions cover:
- Intuitive handling of the QCRx® interface,
- Configuring assay and analysis protocols,
- Best practices for integrating automated analytical control into PUI workflows.
These modules anchor GMP preparation practices in a practical and secure digital environment.
Thanks to the QCRx® software architecture, every step is fully digitized: from label entry to automatic results archiving, including real-time monitoring of quality indicators. One-click reports facilitate monitoring and traceability, while eliminating the need for double visual inspection.
These technological advances make analytical control not only fast (less than 70 seconds per sample), but also accessible to all team members, regardless of their experience level. Ultimately, QCRx® paves the way for a more agile PUI, where training and innovation translate into significant time savings and a reduction in human risks.
Learn how QCRx® controls your pharmaceuticals in less than 70 seconds.
Practical case: trastuzumab bag
In an oncology department, a preparation of trastuzumab 150 mg/250 ml in NaCl solution was subjected to quality control via QCRx®. The analysis revealed 99.9% control, validating the drug concentration and the absence of particles. This rapid analysis allows for the immediate release of preparations, thus ensuring the safety of patients with oncological diseases by eliminating any risk associated with underdosing or overdosing. This approach ensures optimal traceability of hospital preparations, regardless of the products handled.
A study showing that after checking over 100,000 preparations, 5 to 7% of preparations have a deviation of >10% with a double visual check. QCRx® eliminates this.
Therapeutic innovations thus benefit from optimal traceability in hospital preparations, regardless of the products handled.
Pharmaceutical preparation requires rigor, traceability, and innovation to protect patient health. By combining best practices, compliance with the European framework, and advanced technologies, each pharmacist ensures the quality of the medications dispensed and the best therapeutic use.
Icones Services offers you QCRx®, a complete quality assurance solution proven to guarantee each specialty, whether reimbursable or not, whether it concerns hospital pharmaceutical preparations.
Adopt QCRx® to optimize your manufacturing, ensure error-free delivery, and strengthen quality assurance in your hospital pharmacy department.