Training and Employment Orientation Presentation

QA-PLN-0001 Version 01

QUALITY pLAN

Topics

Quality Intent Statement

Quality Vision Statement

Quality Values Statement

Leadership/ Process Approach/ Continuous Improvement/ Internal Audits

Quality Plan Overview

Quality Implementation Plan

Quality Mission Statement

Main objectives of GHCC for 2024 is to constantly improve standards of Quality, Compliance and Excellence.

Quality Intent Statement

We intend to ensure that the cell therapy administered to the patient is safe, effective, and within compliance.

Quality Mission Statement

Our mission is to cure cancer through innovative cell therapies.

Quality Vision Statement

Our vision is to provide a life-saving cell therapy for every patient in need, whenever needed. Every person battling cancer deserves a second chance at life, and the cure lies within each of us to do our best at GHCC.

Quality Values Statement

We are a team of professionals with a passion for saving lives. Our core values include making cell therapies safe and effective for our patients and positively representing our stakeholders with an innovative product.

Leadership

Engage employees and lead them toward achieving the organization’s goals. Motivate employees to work on achieving them. Therefore, improving their productivity and loyalty.

Be proactive and lead by example to all stakeholders of the business including the suppliers, customers, employees, owners, local communities, and the public.

ENGAGE

PROACTIVE

Process Approach

Emphasize achieving efficiency and effectiveness in organizational processes.

EMPHASIZE

CONTINUOUS IMPROVEMENT

Ongoing improvement of processes, services, and products.

Minimize project costs and help prevent overage.

ONGOING

MINIMIZE

INTERNAL AUDITS

Perform periodic audits to ensure compliance with regulations and laws.

Improvement of current processes and operations enhancing the quality of the service and products.

PERIODIC

IMPROVEMENT

CURRENT SITUATION

Upper management will engage and lead employees toward company goals and initiatives.

qUALITY PLAN OVERVIEW

LEADERSHIP RESPONSIBLE: CEO

TARGET

Company goals and initiatives are not visible and vocally provided to employees in a periodic manner.

PLAN Objectives

OFFSITE MEETINGS Provide two offsite meetings to the entire organization to discuss the company goals and initiatives for 2024 (Jan 2024 and August 2024). In the first biannual meeting, the CEO will present company goals and initiatives to the entire company and then each of the functional areas: Manufacturing, Materials Management, Facilities, Safety, Supply Chain, Quality Control, Information Technology, Quality Assurance, Regulatory and Human Resources will present their departmental goals related to companywide goals presented. 2nd biannual meeting will be an update of all departments on their standings to meet company goals and deliverables by the end of the year 2024.

CURRENT SITUATION

All quality control materials, supplies, and reagents utilized in the testing of GMP clinical lots are to be handled by an electronic inventory system.

qUALITY PLAN OVERVIEW

PROCESS APPROACH RESPONSIBLE: QC/QA/TECH OPS

TARGET

Materials, supplies, and reagents needed by the Quality Control Department for testing are being ordered by employees based on an Excel spreadsheet and notify Supply Chain for the purchase. No material specifications.

PLAN Objectives

INVEST AND IMPLEMENT Invest and Implement an Inventory system for QC materials by EOY 2024. QUALIFY Qualify suppliers of materials, supplies, and reagents. CREATE Create material specifications.

CURRENT SITUATION

Streamline workflows and minimize the approval signature process in Veeva (Quality Management System).

qUALITY PLAN OVERVIEW

CONTINUOS IMPROVEMENT RESPONSIBLE: QA

TARGET

Too many approval signatures within the whole workflow process in different quality systems.

PLAN Objectives

INITIATE QA will initiate lesson-learned meetings with the approval participants in Veeva to evaluate the approval signature requirements and repetitiveness. Validate Configuration updates of affected workflows for approval signatures. Applies to modules: Deviations, Change Controls, LIRs and CAPAs.

CURRENT SITUATION

Internal audit to each department of one specific process.

qUALITY PLAN OVERVIEW

INTERNAL AUDITS RESPONSIBLE: QA

TARGET

Multiple external audits throughout the year. General overview focusing on the tech transfer of processes and GHCC facility.

PLAN Objectives

INTERNAL AUDIT QA will perform an internal audit of operational areas (MFG, MM, and QC). The audit will be dedicated to one specific process to evaluate if any gaps. EXTERNAL AUDITOR Contract an external auditor to audit quality systems and determine clinical phase appropriateness.

qUALITY iMPLEMENTATION PLAN

2024BIANNUAL

FORUM QUALITY COUNCIL

UPDATES Updates at regular intervals within the Quality Council may be needed to refine to ensure optimal achievements of the objectives and business benefits.

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