eipg Archives - European Industrial Pharmacists Group (EIPG)

Real-world evidence for regulatory decision-making


by Giuliana Miglierini Digitalisation is rapidly advancing also in the regulatory field, as a tool to improve the efficiency and accuracy of processes used for the generation and use of data to inform the regulatory decision-making. To this instance, real-world Read more

Webinar: Implementation of Contamination Control Strategy Using the ECA template


The next EIPG webinar will be held in conjunction with PIER and University College Cork on Friday 21st of October 2022 (16.00 CEST), on the implementation of Contamination Control Strategy (CCS) using the ECA* template. This is the second Read more

ACT EU’s Workplan 2022-2026


by Giuliana Miglierini The implementation phase of the Accelerating Clinical Trials in the EU (ACT EU) initiative, launched in January 2022 by the European Commission, started with the publication of the2022-2026 Workplan jointly drafted by the Commission, the European Medicines Read more

Webinar: Implementation of Contamination Control Strategy Using the ECA template

, , , , , , , , ,

The next EIPG webinar will be held in conjunction with PIER and University College Cork on Friday 21st of October 2022 (16.00 CEST), on the implementation of Contamination Control Strategy (CCS) using the ECA* template. This is the second presentation on the CCS, given by Walid El Azab, Senior Manager Technical Services for the Life Sciences Division of STERIS Corporation, an Industrial Pharmacist and a Qualified Person (QP), member of the ECA task force on the revision of Annex 1 and leading expert on the subject.

Manufacturers are required to develop a set of control strategies to confirm their process performance and product quality. Annex 1 introduces a “Contamination Control Strategy” (CCS) approach to ensure process performance and product quality by preventing microorganisms, pyrogens, and particulate contamination.

The presentation explains the implementation of a CCS across a facility and deep dive into the ECA guideline on CCS. An example of CCS implemented by various manufacturers and the ECA CCS template will be presented. This will be followed by a discussion around the future challenges manufacturers may face with the principle of a holistic approach and how novel technology and data science combined with statistics may help in overcoming the future challenges.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.

  • European Compliance Academy

 


Webinar: Contamination Control Strategy, an Implementation Roadmap

, , , , , , ,

The next EIPG webinar will be held in conjunction with PIER and University College Cork on Friday 23rd September 2022 (16.00 CEST), on the implementation roadmap of Contamination Control Strategy (CCS). This presentation is given by Walid El Azab, Senior Manager Technical Services for the Life Sciences Division of STERIS Corporation, an Industrial Pharmacist and a Qualified Person (QP), member of the ECA task force on the revision of Annex 1 and leading expert on the subject.

Manufacturers are required to develop a set of control strategies to confirm their process performance and product quality (EU Annex 2, EU Annex 14, USP1115, USP1116, FDA aseptic guideline, ICH Q10, Q11). The draft Annex 1 introduces a “Contamination Control Strategy” (CCS) approach to ensure process performance and product quality by preventing microorganisms, pyrogens, and particulates contamination.

The presentation explains the implementation of a CCS across a facility. It proposes an implementation roadmap to formulate and deploy a successful CCS. Also, it discusses the processes and environments that must be scanned to formulate a CCS. Then, the presentation proposes a method to make the strategy work as intended by implementing the correct control strategies. Finally, it discusses how a company can assess its CCS level over time and improve it.  During the presentation, an online survey will be launched to assess CCS implementation practices amongst the attendees.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.

 


Webinar: Implications and Opportunities of ICHQ2(R2) and ICHQ14

, , , , , , , , ,

The next EIPG webinar will be held in conjunction with PIER and University College Cork on Wednesday 15th June 2022 (17.00 CEST), on the implications and opportunities of the revision of ICHQ2 (on validation of analytical procedures) and the ICHQ14 (on analytical procedure development). Our speaker Phil Borman, Director and Senior Fellow at GlaxoSmithKline, pioneered the adaptation of Quality by Design principles to analytical procedures and currently co-leads the EFPIA ICH Q2(R2) and ICH Q14 guidance on Quality by Design, will explain why these guidelines are being developed and will highlight their implications and opportunities.

The revision of ICHQ2(R1): Validation of Analytical Procedures and the development of ICHQ14: Analytical Procedure Development reached the key ICH milestone of Step 2 publication for public consultation in March 2022. The combined topic Q2(R2)/Q14 represents an opportunity to provide guidance on how to apply enhanced development approaches (‘Quality by Design’) to analytical procedures and how to use the knowledge obtained to support routine use of procedures. Q2(R2)/Q14 will also have the potential to facilitate the selection or identification of development approaches that will reduce the risk incurred by post-approval changes to analytical procedures discussed in ICHQ12: Pharmaceutical product Lifecycle Management. This webinar will explain why these guidelines are being developed as well as highlighting the implications and opportunities.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.


Academic Research in industrial pharmacy field

, , , , , , , , , , ,

By Anni Svala

Dear Colleague,

As a part of our University of Helsinki Industrial Pharmacy specialization studies we are conducting a research of remote audits.

The purpose of our academic study is to gather information and knowledge about remote audits together with the company practices and remote audit policies. The study consists of an audit survey created with the Webpropol® survey platform.

On our studies, we research both the Auditor and the Auditee experiences and points of view.

The supervisor of the study is Professor Anne Juppo from University of Helsinki, Faculty of Pharmacy (e-mail: [email protected]).

All responses are anonymous and the respondents cannot be recognized by the survey results.

In case you have experience in both Auditor and Auditee perspective, we would highly appreciate it if you could answer the survey twice, once for each point of view.

The survey material is solely collected for the study purposes to which this invitation to response also includes. All study material is archived and kept on our personal computers for 6 months after the study publication, after which the material is destroyed.

Answering the electronic survey will take approximately 15-20 minutes. Link to the survey is at the end of this letter. This survey has been sent as a sampling to Auditors and quality professionals working in pharmaceutical companies and wholesale distribution companies.

Our study will be completed during summer 2022 and it will be published in an academic journal. Our research is also stored in the publication archive of the University of Helsinki, where it is freely readable.

Please fill in your contact information via separate link after answering the survey questions if you wish to receive the publication when available.

The survey is open until 17 April 2022.

If you have any questions regarding our research feel free to contact us by email.

Link to the survey: 

https://link.webropol.com/s/Uni-Helsinki-audit-survey2022

Our utmost gratitude for giving a moment of your time to answer to our survey.

Kind regards,

Terhi Liukko & Anni Svala

University of Helsinki, Faculty of Pharmacy

Industrial Pharmacy Specialization students
[email protected], [email protected]


Continuous Manufacturing of Pharmaceuticals: Higher Quality, Greater Flexibility

, , , , ,

The next EIPG webinar will be held in conjunction with PIER and University College Cork on Wednesday 30th March 2022 (17.00 CEST), on Continuous Manufacturing of Pharmaceuticals. Giustino Di Pretoro a subject matter expert and drug product development lead will provide his expert practical experience of continuous manufacturing. Our speaker is Giustino Di Pretoro the Scientific Director at Janssen Pharmaceutica, a Johnson & Johnson Company. He is a subject matter expert and drug product development lead for continuous manufacturing, and coordinator for a series of academic collaborations within the field.

For more than 50 years, pharmaceuticals have been produced using a method known as “batch manufacturing,” a multi-step, lengthy process that usually involves the use of large-scale equipment. However, recent advances in manufacturing technology have prompted the pharmaceutical industry to consider moving away from batch manufacturing to a faster, more efficient process known as “continuous manufacturing”. The Regulatory Agencies are taking proactive steps to facilitate the pharma industry’s implementation of emerging technologies, including continuous manufacturing, to improve product quality and to address many of the underlying causes of drug shortages and recalls. Our speaker will provide his expert practical experience of continuous manufacturing.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.