Good pharmaceutical practices (BPP): quality and safety of preparations

What are good pharmaceutical practices?

The term “good pharmaceutical practices” refers to all the standards governing the quality of pharmaceutical work. For preparations, the reference text in France is the guide to Good Preparation Practices (BPP). Article L.5121-5 of the Public Health Code requires every medicinal preparation to be made in accordance with good practices whose principles are set by decision of the ANSM.

The guide covers the three categories of preparations defined in article L.5121-1 of the same code: magistral, hospital and officinal. It is aimed at hospital pharmacies, whose missions include making preparations (article L.5126-1), community pharmacies, and organizations that carry out preparations or controls under subcontract.

Hospital pharmacists are encouraged to adopt a culture of proof rather than a culture of process.

In practice, this means standardized documentation, ongoing training, anticipated risk management and control resources able to demonstrate, preparation by preparation, that the product complies.

What the 2023 edition changes

The ANSM decision of 21 July 2023, in force since 20 September 2023, replaces the edition of 5 November 2007. The revision incorporates Council of Europe resolution CM/Res(2016)1, the French Nuclear Safety Authority's regulations for nuclear medicine and the IGAS recommendations on pediatric parenteral nutrition. It was drafted by a committee of hospital and community pharmacists, inspectors and academics.

The 9 chapters of the guide

The guide consists of nine general chapters, annexes giving implementation examples, guidelines specific to certain types of preparations and a glossary.

1. Pharmaceutical quality system management
2. Staff
3. Premises and equipment
4. Documentation
5. Preparation operations
6. Pharmaceutical quality control
7. Outsourced activities (subcontracting)
8. Complaints and recalls
9. Self-inspection

The guidelines are cumulative. The preparation of injectable cytotoxic chemotherapies, for example, follows the general chapters, guideline 1 (sterile preparations) and guideline 2 (substances that may present a risk to health and the environment). See the guide on cytotoxic preparations.

BPP and GMP: what is the difference?

Good Manufacturing Practices (GMP) govern the industrial production of medicines, from the receipt of raw materials to batch release. They are defined at European level by EudraLex (volume 4) and, internationally, by WHO recommendations. They apply to pharmaceutical companies. In hospital pharmacies and community pharmacies, the BPP apply.

Both standards share the same logic: a documented quality system, qualified premises and equipment, trained staff, and release based on evidence.

What the BPP mean for hospital pharmacies

Risk analysis and traceability

The risk assessment of each preparation determines the resources to be deployed. Each batch must be traced, from receipt of raw materials to release, in a batch record checked before any decision.

Control and release strategy

The BPP do not impose a single control method: the type of controls and the release strategy follow from the risk analysis (points 1.9, 6.59 and 6.70). For high-risk preparations such as injectable chemotherapies, the SFPO recommends checking every preparation and replacing visual double-checking, as far as possible, with analytical, gravimetric or digital methods (recommendation no. 17).

This is where analytical control of the finished product comes in: the QCRx® verifies the molecule, concentration and solvent in under 70 seconds per IV bag, then archives a time-stamped report that goes into the batch record.

Training and quantities produced

The guide insists on ongoing training, with operators regularly assessed and authorized. The quantities prepared per batch must correspond to a foreseeable number of patients treated over a given period.

By adopting a risk-based approach, hospital pharmacies equip themselves with a robust framework, in line with the ANSM's expectations. Analytical control of the finished product makes it possible to meet them without slowing down releases.

Frequently asked questions