Manual for Sterile Preparations 3rd Edition (2026)

This comprehensive manual has been updated to align with the latest international standards. The guideline details the essential components of Good Preparation Practice (GPP) for various sterile pharmaceutical preparations, including cytotoxic drug reconstitution, parenteral nutrition, IV admixtures, eye drops, and sterile radiopharmaceuticals.

Strict adherence to these guidelines is crucial to ensure the quality, safety, and efficacy of the prepared products, while simultaneously safeguarding personnel and the environment, particularly during the handling of hazardous drugs.

The third edition introduces several significant enhancements to uphold best practice standards. Key updates include revised disinfection protocols and incubation temperature specifications, detailed documentation requirements for third-party performance testing reports, and updated cleanroom classification parameters. New additions, such as a standardized Deviation Reporting Form and an evaluator comment section in the personnel training checklist, have also been incorporated to further strengthen documentation and quality assurance processes.