Aseptic Processing in Manufacture of Sterile Products & ATMPs
Aseptic Processing in Manufacture of Sterile Products & ATMPs

Course Description

There is a significant increase in Aseptic processing as more and more products and advance therapies are developed with biological mechanisms that are impacted by Terminal Sterilisation. The revision and implementation of EU GMP & PICS Annex 1 has significantly impacted Aseptic processing; in design, control, qualification, monitoring and product testing. It is important to understand these challenges and regulatory requirements/ trends and join the discussion on how we meet these challenges.

This 3-day online training will cover GMP regulations and regulatory expectations in Aseptic manufacturing of sterile medicinal products and ATMPs including key points in compliance to the revised EU GMP Annex 1 that encourages increased application of Quality Risk Management (QRM) principles (ICHQ9(R1)) over the product life cycle (ICHQ12). Details will be provided of manufacturing technologies to improve efficiencies and GMP compliance together with guidance on how to prepare a Contamination Control Strategy (CCS) and if required aseptic-containment strategy. The training extends into process operations covering best practices; Good aseptic technique, good Cleanroom behaviour together with good training practices (including increased use of VR (virtual reality).

The connection between Control Strategies though CMC and GMP, including Cross contamination Control strategies will be discussed for ATMPs and Biologics. Small and large molecule processing will be considered in downstream processing where bioburden control applies and connection to Aseptic process with Fill and Finish in different dose forms: Vials, Syringes, Ampoules, Cartridges and IV Bags

Changes in regulations and new GMP requirements challenge all industries but also considering the growth in biologics/ ATMPs for more targeted personalised/ individualised medicines and the paradigm shift away from big ‘block buster products’ the need to understand aseptic processing and regulatory expectations has never been more current. Vaccines have become a new ‘Block buster’ manufactured at large batch scale that use biologics requiring aseptic processing with high efficiencies provided by automation.

New aseptic processing platforms are following five ‘pillars’ that characterise an advanced approach, including: Flexibility, Modularity, Intensification, Digitalisation and Automation.

Key takeaways include

  • GMP regulation changes and their impact on Aseptic processing
  • QRM what this really means and how it is applied
  • Contamination Control Strategy (CCS) and considerations in aseptic processing
  • Barrier separation technologies, alternatives for aseptic processing of different product types e.g., Pharmaceuticals, biologicals, ATMPs and toxic products – small and large batches
  • Application of single use systems, RTU: Ready to Use product containers and closures in barrier technologies considering transfers into Grade A and bio-compatibilities
  • Application of large batch vial filling for liquid and freeze-dried products considering environmental zoning in transfers, application of UDAF, localised UDAF and Grade A air supply plus the surrounding environment
  • Integration of automation with GMP compliance in manufacturing environments
  • How to apply EM and PM as measures of collective effectiveness of contamination control measures
  • Digitalisation of data, data analysis/ trending and data to support batch release.
  • Future trends in aseptic processing

The revision of Annex 1 EU GMP for manufacture of sterile medicinal products marks a paradigm shift in regulations taking a more risk based, holistic and proactive approach to managing contamination and product quality in manufacturing. To support the paradigm shift ICHQ9(R1) QRM: Quality risk management has been revised to focus on hazard and risk knowledge before applying risk control mitigations to move away from the subjectivity of risk assessments that tend to focus on risk priority numbers (RPNs) that can lead to poor justifications of unacceptable risks. Regulators consider the full benefit of QRM is not being realised hence the revision of ICHQ9 (R1) and direct linkage to Annex 1 to engage this essential principle. Such regulatory changes impact key elements of aseptic processing and keeping current requires an understanding of these changes and impact. This essential training will cover key points to consider as result of regulatory changes and possible solutions to regulatory requirements that may be an expected or necessary process improvement.

Aseptic Processing in Manufacture of Sterile Products & ATMPs

12 - 14 March 2024, Live Online Training
€1.850,00
James L. Drinkwater

James L. Drinkwater is the current Head of GMP Compliance at Franz Ziel Germany. James is based in the UK for the global role and separately supports the Not-for-profit society: Pharmaceutical and Healthcare Sciences Society: PHSS an educational platform in GxP. James is the ex-Chairman (10 years) of the PHSS and currently Co-leads the Annex 1 and CCS Guidance focus groups.

START TIMES

1:30 PM Vienna time

12:30 PM London time

8:30 AM New York time

5:30 AM Los Angeles time

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Course Description

There is a significant increase in Aseptic processing as more and more products and advance therapies are developed with biological mechanisms that are impacted by Terminal Sterilisation. The revision and implementation of EU GMP & PICS Annex 1 has significantly impacted Aseptic processing; in design, control, qualification, monitoring and product testing. It is important to understand these challenges and regulatory requirements/ trends and join the discussion on how we meet these challenges.

This 3-day online training will cover GMP regulations and regulatory expectations in Aseptic manufacturing of sterile medicinal products and ATMPs including key points in compliance to the revised EU GMP Annex 1 that encourages increased application of Quality Risk Management (QRM) principles (ICHQ9(R1)) over the product life cycle (ICHQ12). Details will be provided of manufacturing technologies to improve efficiencies and GMP compliance together with guidance on how to prepare a Contamination Control Strategy (CCS) and if required aseptic-containment strategy. The training extends into process operations covering best practices; Good aseptic technique, good Cleanroom behaviour together with good training practices (including increased use of VR (virtual reality).

The connection between Control Strategies though CMC and GMP, including Cross contamination Control strategies will be discussed for ATMPs and Biologics. Small and large molecule processing will be considered in downstream processing where bioburden control applies and connection to Aseptic process with Fill and Finish in different dose forms: Vials, Syringes, Ampoules, Cartridges and IV Bags

Changes in regulations and new GMP requirements challenge all industries but also considering the growth in biologics/ ATMPs for more targeted personalised/ individualised medicines and the paradigm shift away from big ‘block buster products’ the need to understand aseptic processing and regulatory expectations has never been more current. Vaccines have become a new ‘Block buster’ manufactured at large batch scale that use biologics requiring aseptic processing with high efficiencies provided by automation.

New aseptic processing platforms are following five ‘pillars’ that characterise an advanced approach, including: Flexibility, Modularity, Intensification, Digitalisation and Automation.

Key takeaways include

  • GMP regulation changes and their impact on Aseptic processing
  • QRM what this really means and how it is applied
  • Contamination Control Strategy (CCS) and considerations in aseptic processing
  • Barrier separation technologies, alternatives for aseptic processing of different product types e.g., Pharmaceuticals, biologicals, ATMPs and toxic products – small and large batches
  • Application of single use systems, RTU: Ready to Use product containers and closures in barrier technologies considering transfers into Grade A and bio-compatibilities
  • Application of large batch vial filling for liquid and freeze-dried products considering environmental zoning in transfers, application of UDAF, localised UDAF and Grade A air supply plus the surrounding environment
  • Integration of automation with GMP compliance in manufacturing environments
  • How to apply EM and PM as measures of collective effectiveness of contamination control measures
  • Digitalisation of data, data analysis/ trending and data to support batch release.
  • Future trends in aseptic processing

The revision of Annex 1 EU GMP for manufacture of sterile medicinal products marks a paradigm shift in regulations taking a more risk based, holistic and proactive approach to managing contamination and product quality in manufacturing. To support the paradigm shift ICHQ9(R1) QRM: Quality risk management has been revised to focus on hazard and risk knowledge before applying risk control mitigations to move away from the subjectivity of risk assessments that tend to focus on risk priority numbers (RPNs) that can lead to poor justifications of unacceptable risks. Regulators consider the full benefit of QRM is not being realised hence the revision of ICHQ9 (R1) and direct linkage to Annex 1 to engage this essential principle. Such regulatory changes impact key elements of aseptic processing and keeping current requires an understanding of these changes and impact. This essential training will cover key points to consider as result of regulatory changes and possible solutions to regulatory requirements that may be an expected or necessary process improvement.

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Aseptic Processing in Manufacture of Sterile Products & ATMPs

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