Microbial data deviations are test results that exceed the established specifications or acceptance criteria in a drug application, drug master file, official compendia, good manufacturing practices, or internally by the manufacturer. This includes, but is not limited to, results generated during utilities monitoring, active principal ingredients, materials, in process control and semifinished product testing as well as during environmental monitoring. The validity of the test results is supported by a documented laboratory and manufacturing investigation. A Contamination Control Strategy (CCS) is a cyclical process designed to prompt the manufacturers to identify and resolve risk. A (CCS) should be implemented across the facility to assess the effectiveness of all control and monitoring measures employed by a company. And this is living across the lifecycle of the product/process within an effective Quality Management System.
This presentation includes a holistic approach for conducting a microbiological investigation. It provides a framework to support the investigation of the root cause of microbial data deviations, focusing on all contributing areas, such as sampling, test methodology, and suitability of the test.
An effective CCS is a key enabler to ensuring Compliance to the revised Annex 1 GMP. The preparation of a CCS is challenging and requires a multi discipline team with full process and scientific knowledge. An effective roadmap planning is needed to ensure an identification and assessment of all key components where Contamination Control applies.
FDA’s regulatory requirements for Biologics License Applications. The presentation will also cover regulatory guidance for sterile products manufactured by aseptic processing.
FDA’s application review process for biological products manufactured by aseptic processing.
FDA’s Pre-license and pre-approval inspection coverage for aseptic processing.
Aseptic processing principles following a Quality Risk Management (QRM) approach that includes Quality by Design (QbD). Resolving the conflicts of EU GMP Annex 1 and GMP for ATMPs.
Applying the ATMP manufacturing platform attributes of: Flexibility/ adaptability, digitalization, modularity, scalability and intensification together with GMP compliance in a viral vector formulation and filling process including vial and bag container formats.
Characterization of protective airflow and ‘First air’ protection in bioburden control and aseptic processing steps considering how protective airflow product products, what puts protection at risk and how to manage the limitations of environmental and process monitoring (Annex1 GMP requirement).
