A Best Practice Approach For a Compliant Annex 1 Biocide Qualification
Learn about the most important aspects of biocide qualification to minimize workload and comply with the regulator’s expectations.
Intermediate to expert
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Determining the efficacy of biocides is critical for maintaining the bioburden levels under control to have a safe, robust and reproducible pharmaceutical process.
However, qualification of biocides is a challenging process, which requires you to consider many parameters and regulatory requirements. Not doing it correctly may lead to contaminations and regulatory complications, which could lead to business shut-down.
This training will help you consider the most important steps in biocide qualification on the surface and accomplish the authorities’ expectations.
This will ease the work of the operators and SME to understand how the biocide will maintain the bioburden of the facility under control.
Completing this course will help you:
Who is the training for?
The webinar will be highly beneficial to anyone involved in a GMP aseptic production. That includes quality professionals, productions operators, validation experts, Contaminations Control Strategy SMEs, auditors and regulators.
- Type of microorganisms.
- Contact time.
- Log reduction.
- Cleaning vs disinfection (differences).
We will highlight the keywords of the Annex 1 draft in regard to biocides.
- Typical standards followed in EU (EN13697, EN 16615)
- To identify the microorganisms found during the environmental monitoring in critical areas. If not possible, take ATCC standard strains. Do not forget to test Pseudomonas or other water-related microorganism, and fungi.
- To study the historical data and trending of the microorganisms.
- Contact time
- Adequate supplier qualification.
- Acceptance criteria of the biocide efficacy.
- How many biocides batches to test.
- Scientific variables to consider.
- What to do when biocide passes the laboratory qualification.
- Bad gowning procedure or bad quality of the fabric.
- Operators training.
- Biocide concentration mistakes.
- Residues of biocides not cleaned.
- Biocides rotations not clear.
- Poor material transfer.
- SOPs unclear /not robust.
- Non robust environmental monitoring.
- Not respect contact times
About the speakers
Yan is a GMP quality expert and the managing director at Qualistery GmbH. Through his vision, the company takes complex GMP topics and transforms them into engaging and enjoyable GMP training videos and training programs that captivate the audience. As a result, GMP professionals retain more information, which they can successfully use in their workplace. This is highly beneficial for the employer as for the career of employees.
Marc García Gómez
Marc is an expert on the qualification of disinfectants and sporicides and validation of cleaning and disinfection processes of Pharmaceutical Facilities. Marc is the author of various articles in Spanish pharmaceutical magazines about cleaning and disinfection. Marc has performed training sessions in dozens of pharmaceutical manufacturing sites about personnel behaviour, hygiene and gowning, cleaning and disinfection of surfaces, Contamination Control Strategy and Risk Analysis following ICHQ9 principles.