6A-0414:00-14:40Key Points in Process Design During the Basic Planning of API Plants

The main challenge in the basic planning of pharmaceutical API is the process of constructing the manufacturing scale process flow from pilot scale test results. For pharmaceutical APIs, most processes are batch processes from a quality assurance perspective, and the rates of heat transfer and diffusion affect the process productivity, which in turn significantly impacts the plant scale and project cost.
In this presentation, we will outline how the documents created during the basic planning phase relate to each other from the perspective of process optimization. We will then discuss the impacts of rates of heat transfer and diffusion on plant scale using specific calculations.

SpeakerTakashi Yahiro
Head of Engineering & Design Division, Engineering Business Department
CM Plus Corporation

4C-0313:00-13:45Project Execution Incorporating the Concept of Lean Qualification Approach

Lean Qualification Approach (LQA) is a method proposed by CM Plus for efficiently conducting qualifications during the installation phase of pharmaceutical and medical device manufacturing facilities while complying with regulatory requirements. In 2015, PIC/S Annex 15 was revised to specify requirements for validation. Additionally, ISPE’s Baseline Guide Volume 5 Commissioning and Qualification introduced the idea of utilizing FAT and SA for qualification. Based on these concepts, CM Plus has developed LQA as a qualification method incorporating risk assessment and has been refining it through practical application.

This presentation will explain the benefits of adopting LQA and provide an overview of the methodology.

SpeakerTakashi Ito
Head of Professional Services Division
CM Plus Corporation

4C-0515:45-16:30Addressing Contamination Control Strategy (CCS) Following the Revision of PIC/S GMP Annex 1

This session will organize the basic concepts and requirements pertaining to the key term “Contamination Control Strategy (CCS)” introduced in the revised PIC/S GMP Annex 1 in 2022. We will explain how to formulate and document a CCS, referencing guidelines like the ECA, and introduce examples of CCS documentation.

SpeakerNoriki Sakata
Head of Validation Department, Professional Services Division
CM Plus Corporation