ANNUAL CONGRESS A3P MIDDLE EAST 2025

In the complex landscape of pharmaceutical manufacturing, effective vendor management is critical to ensuring product quality, regulatory compliance, and supply chain efficiency. This 7-hour workshop offers an in-depth exploration of the key aspects of vendor management, designed for professionals involved in vendor oversight and quality assurance.
Participants will gain insights into the systematic process of vendor selection, emphasizing criteria that align with organization standards and regulatory requirements. A detailed discussion on vendor classification will follow, covering risk-based classification frameworks and their applications in ensuring that resources are allocated effectively across different types of vendors. The workshop will outline the essential documentation for vendor selection, providing clarity on necessary contracts, agreements, and quality assessments to meet compliance standards.

The course will then delve into the fundamentals of vendor audits, explaining the planning, execution, and follow-up required to evaluate vendor compliance with quality standards and regulatory expectations. Additionally, we will examine vendor oversight strategies to maintain ongoing quality and compliance throughout the vendor relationship. Vendor performance analysis will round out the session, focusing on metrics, scorecards, and improvement plans to ensure consistent, high-quality outputs from vendors.

Through a mix of lectures, case studies, and interactive discussions, attendees will leave with a comprehensive toolkit for managing vendors in a way that minimizes risk and maximizes quality, efficiency, and regulatory compliance in pharmaceutical operations.

During the workshop, the following topics will be addressed:

- Current regulations including new version of EU Annex 1,

- Exhaustive review of requirements in terms of process and hold-times.

- Aseptic process simulation effort depending on: Technologies: RABS vs. isolators, Pharmaceutical forms: liquid vs lyophilized products, Primary components: pre-filled syringes vs. vials,

- Understand the worst-case and bracketing approach,

- Processes and operators (re)qualification. To fully understand the concepts of APS, a case study will be submitted to attendees. The context of the case study is a new product introduction in a Contract Manufacturing Organization (CMO) having different technologies and pharmaceutical forms. The exercise will determine if additional APS is needed to introduce the new sterile product in the facility and, due to the new EU Annex 1 release, if any gaps need to be solved.

Alternative methods for bioburden monitoring are gaining more and more attention in the pharmaceutical industry. Various technologies are now available, but still it is a challenge for the user to implement these technologies since they generate data that are not correlating to the numbers generated by plate count methods. And furthermore, there are no limits defined in regulatory documentation. In this workshop we want to demonstrate, with the example of flow cytometry as an alternative and fast method, how the data can be used for IPC and QC. There are well known and already accepted methods for data interpretation and generation of limits that can be applied

During the workshop, we will examine various methods advised for characterising a Biosimilar. The significance of employing orthogonal methods to address critical Quality Attributes will be discussed

During the workshop, we will examin :

Why is it important to define Critical Process Parameters (CCP)

What are the critical CCPS´s for BFS process

How to detemine and identify the CCP´s

Working groups for different BFS products to define the CCP´s in a working group and present the results