| Die neue FDA Aseptic Guidance Teil 3: Qualifizierung / Validierung*) Hanfried Seyfarth Biopharmaceutical Quality & Compliance / Mikrobiologie, Boehringer Ingelheim Pharma KG, Biberach/Riss
The New FDA Aseptic Guidance / Part 3: Qualification/Validation To guarantee the sterility of products the various steps of the aseptic manufacturing should be validated. The FDA Aseptic Guidance makes indications to the validation of sterilization and performance of media fills as well as to several validations and qualifications. Details regarding media fill are listed, such as study design, frequency and number of runs, duration of runs, size of runs, line speed, environmental conditions, media, incubation, examination of media-filled units, interpretation of test results.
The Guidance points out that details as to the validation of sterilization processes should be taken from the corresponding special guidelines. The Guidance describes only additional procedures and practices. Validations are also required for disinfectants. Routinely used disinfectants should be effective against the normal microbial vegetative flora recovered from the facility.
Filtration is a common method of sterilizing drug product solutions and has to be validated, too. It should be demonstrated the filter is able to reproducibly remove microorganisms from the solution, producing a sterile effluent. The FDA Aseptic Guidance gives instructions for the practice of validation. It is the responsibility of the pharmaceutical producer to review the tests, even if these are conducted by the filter manufacturer. Finally, the Guidance demands the following validations and qualifications:
• qualification of air systems,
• validation of isolator systems,
• appropriate training and qualification of clean room personnel should be conducted before an individual is permitted to enter the clean room,
• validation studies for depyrogenisation of containers and closures,
• establishing time limits for solutions etc.
Key words Aseptische Herstellung • FDA Aseptic Guidance |
