Are you wondering how to ensure the quality and safety of every preparation within the strict regulatory framework of hospital pharmacies? This article provides an overview of Good Pharmaceutical Practices, from regulatory fundamentals to good manufacturing practices, including compliance requirements, to give you clear and practical solutions. Discover how to optimize your processes, manage the risk of errors, and enhance patient safety, while meeting the expectations of health authorities such as the ANSM.
Table of Contents
- Foundations of Good Pharmaceutical Practices
- Good Manufacturing Practices in the Pharmaceutical Industry
- Good Practices for Hospital Preparations
Foundations of Good Pharmaceutical Practices
Definition and Objectives of Good Pharmaceutical Practices (GPP)
All pharmacists, including those working in hospital pharmacies (PUI – Pharmacie à Usage Intérieur), are required to ensure a high level of quality in their practices. They must promote professional excellence in the service of public health. Good Pharmaceutical Practices (GPP) concretely embody this principle by regulating the quality of pharmaceutical preparations in daily hospital practice.
In line with international recommendations, national standards must be established to continuously improve pharmacy practice. In France, for example, the ANSM decision of August 2, 2023 sets the new binding framework for hospital pharmacies regarding Good Preparation Practices (GPP). It strengthens the requirements introduced in 2007, particularly regarding risk analysis, enhanced controls, staff training, and limits on batch production volumes, as also highlighted by the National Order of Pharmacists.
Thus, GPPs are now the enforceable standards for hospital pharmacists: they define requirements for traceability, safety, and compliance at every stage of the medication circuit. Their application is a central lever for risk management.
Regulatory Framework for Good Pharmaceutical Practices (GPP)
Requirements across member countries are converging with European practices.
In France, the alignment of the 2023 GPP framework with the GMP Guide Annex 17 on real-time release reflects a shared commitment to regulatory harmonization at the European level.
Similarly, in Belgium, the Federal Agency for Medicines and Health Products (AFMPS) published a similar guide in 2009, setting requirements for sterile and non-sterile hospital preparations.
These regulatory alignments demonstrate a common desire to harmonize practices based on robust scientific and qualitative principles. Today, hospital pharmacists are encouraged to adopt a culture of evidence rather than a culture of process, justifying each decision with traceable and enforceable data.
This approach requires organizational adaptation: standardized documentation, enhanced training, proactive risk management, and the use of efficient analytical control systems.
Good Manufacturing Practices in the Pharmaceutical Industry
Fundamental Principles of GMP
Good Manufacturing Practices (GMP) regulate drug production under strict standards. They aim to ensure consistent product quality at every stage of manufacturing, from raw material receipt to batch release. These standards are mainly defined by European regulations, including the GMP Guide in Volume 4 of EudraLex, and by World Health Organization recommendations, such as detailed in the Technical Report Series TRS 986, Annex 2.
The general GMP principles also apply to PUIs to the extent that some of their preparations are highly critical, including cytotoxic drugs, sterile preparations, or medicines under ATU (Temporary Authorization for Use). Each step requires validated procedures, qualified equipment, controlled facilities, and trained operators.
| Component | Requirements |
|---|---|
| Products | Compliance with physicochemical specifications |
| Processes | Documented validation, in-process controls |
| Facilities | Controlled clean environment, pressure, zoning |
| Equipment | Qualified, maintained, cleaned according to validated SOPs |
| Personnel | Trained in GMP, authorized, subject to competency monitoring |
In France, these requirements are adapted by the ANSM depending on the type of preparation and associated risks, as indicated in the 2023 version of the GPP.
Documentation and Batch Release
In GMP, documentation is not merely administrative—it is a core part of the quality system. Every manufacturing step must be meticulously recorded in a batch record, which is then reviewed by the responsible pharmacist before release. This record includes:
- The exact list of raw materials used, including lot numbers and suppliers;
- The equipment used for each operation, along with their qualification and maintenance status;
- Results of in-process controls (pH, osmolarity, concentration, sterility, etc.) and end-process tests;
- Any observations, deviations, and the justified decisions for release or rejection.
This systematic traceability is essential to ensure regulatory compliance and enhance patient safety. In France, final batch release is under the legal responsibility of the pharmacist, in accordance with Article R.5124-36 of the Public Health Code. The pharmacist relies on the European Pharmacopoeia and national standards to validate each release in an enforceable manner during inspections or audits.
Importance for PUIs
In hospitals, adherence to GMP is a strategic lever to secure treatments, ensure regulatory compliance, and minimize deviations during inspections. PUIs must manage operational challenges: high volumes, strained teams, diverse preparations…
To address these challenges, some PUIs use analytical control systems such as internal HPLC, enhanced manual double checks, or newer devices like QCRx, allowing finished products to be certified automatically in under 70 seconds. QCRx® provides practical solutions for traceability, efficiency, and robustness as expected by health authorities.
Learn how QCRx® controls your pharmaceuticals in less than 70 seconds.
Good Practices for Hospital Preparations
Scope and Purpose
Good Preparation Practices (GPP) apply to hospital pharmacies (PUIs) that prepare medications for a patient or group of patients. Preparations include sterile forms (cytotoxic drugs, parenteral nutrition, injectable antibiotics) and non-sterile forms (solutions, capsules, ointments).
The 2023 ANSM GPP guide strengthens PUI requirements in four key areas:
- A systematic and documented risk analysis approach;
- Expanded preparation controls, including outsourcing;
- Enhanced operator training;
- Stricter definition of batch production quantities.
Risk Analysis and Traceability
Each preparation must undergo a formal risk analysis based on the drug type, route of administration, target population, and preparation complexity. Educational annexes in the 2023 GPP guide provide analysis grids and a preparation dossier template.
Every batch must be traced: from raw material receipt to release, including in-process controls, deviations, and release authorizations. Traceability is a core aspect of compliance and patient protection.
Preparation Controls
Preparation controls may be conducted internally or outsourced to external laboratories. The frequency and nature of tests (assay, identification, sterility, pH) are risk-adapted.
The PUI is responsible for every released batch. Devices like QCRx® enable real-time analysis without sampling, with automatic archiving and digital traceability.
Operator Training and Supervision
The 2023 GPP guide emphasizes continuous training. Minimum frequencies are recommended for personnel handling sterile and toxic preparations. Operators must be regularly assessed and authorized, with competency tracked in individual records. PUIs should also provide adequate supervision to ensure process reliability and strengthen internal quality culture.
Limitation of Batch Quantities
Batch quantities must no longer be arbitrarily set; they should correspond to a predictable number of patients over a given period. This criterion aims to reduce waste, prolonged storage, or misuse.
The justification of produced quantities must appear in the preparation dossier, alongside planning and prescription details. This is a stricter requirement compared to the 2007 GPP guide.
Implementing the new Good Preparation Practices in PUIs requires structural reflection on processes, skills, traceability, and tools. By adopting a risk-based approach, hospital pharmacies establish a robust framework aligned with ANSM expectations. Technologies like QCRx® help meet these requirements while improving efficiency and peace of mind.