Our Quality Management System (QMS) ensures that our quality system complies with FDA, EU and NMPA GMP requirement regarding material & supplier management, manufacturing management, data integrity, Good Documentation Practice (GDP) management, etc.
Our GMP facilities, equipment and personnel are strictly governed, monitored, and documented, to ensure that we can provide the best support to our clients covering all stages from development to commercial production.
Our carefully constructed core QMS governing structure consists of Quality Manual, Quality Policy, SOPs, Records, Forms, Protocols and Reports etc.
The Quality Manual is the highest-level document in Porton Advanced’s quality system, and any document shall not confilct with or be inconsistent with it. In case of any conflict, Quality Manual shall prevail unless otherwise stated. The Quality Policy describes the management strategy for different aspects of the quality system on the basis of Quality Manual. All Standard Operating and Management Procedures, Quality Specifications, Process Procedures or Job Descriptions are included in the documents that guide operations. Finally, Records, Protocols, Forms and Reports are the cornerstone of our quality system and are used to demonstrate that the quality system is in good operation.
Based on risk and science, the QMS regulates all of our operations, should be applied as appropriate to all projects and products at all stages.
The QMS Guides:
The regulations, including PDA Technical Report No. 56 (Revised 2016) titled "Application of Phase-Appropriate Quality Systems and cGMP to the Development of Therapeutic Protein Drug Substances (API or Biological Active Substance)" and the China GMP Annex: Drugs for Clinical Trial (Trial), highlight the need for companies to implement different quality control strategies at various stages of product development. Following these regulations, Porton Advanced developed the document "Quality Control Management for Products at Different Manufacturing Stages" (SOP-SZQS-0088) to outline the quality management requirements for transfer batches, engineering runs, and commercial batches.
Any minor changes during early clinical phases must be documented in the batch record for change control. If document updates or changes affect multiple sections, they should be implemented according to the corresponding Standard Operating Procedure (SOP). Key and major changes are to be implemented based on the change control SOP. For pivotal clinical trials, process performance qualification (PPQ), or commercial batches, changes must also be implemented following the change control SOP.
In terms of safety management, the strategies employed are consistent across both clinical phase I and commercial stages. These strategies include selection of raw materials and vendors, personnel training and management, facility utilities, and equipment.
IIT cell products are manufactured in a GMP facility that follows GMP quality management practices. This includes personnel training and education, infectious disease screening, instructional and measurement equipment validation, and periodic maintenance. Each project is assigned its own production suite, which is cleaned, sanitized, and monitored regularly. Due to the inherent uncertainties in the process, any process-related deviations must be recorded in the batch record. Changes should be documented according to GMP protocols.
The quality management system for cell banks must align with the specific stage they are supporting. In general, the cell bank is intended to support viral vector manufacturing up to the commercial stage, it should adhere to Good Manufacturing Practice (GMP) standards.
Typically, viral vectors serve as intermediates for cell therapy, while plasmids act as the starting materials for these viral vectors. Therefore, plasmid production should be held to the GMP-like standard at the clinical and commercial stages.
If mRNA is used as a final product in patient treatments, the quality management for mRNA should be held to the same standards as that for cell therapy products. If mRNA is used as raw materials used for cell therapy gene modification/gene editing, the quality management for mRNA should be held to the same standards as that for intermediate products.
In general, viral vectors serve as raw materials for manufacturing cell therapy products. However, the document "Cell Therapy Production Inspection and Guidance" released in January 2025 states that the guidance also applies to viral vectors used for cell therapy modification or other applications. Therefore, during manufacturing, quality control testing, and product release, viral vectors should adhere to the same management standards as those applied to cell therapy products.
Microbial banks should support plasmid manufacturing through to commercial stages. Since the commercial stage plasmid must be manufactured under GMP-like quality control management, microbial banks should be managed using the same approach.
The registration batch should be manufactured in a GMP (Good Manufacturing Practice) facility. All systems, including the air conditioning system, water system, periodic environmental monitoring, material release, equipment maintenance, and personnel management, must be managed in accordance with GMP regulations. If any deviations occur during system operation, the procedure should be followed as outlined by GMP standards.
Due to process uncertainties, any deviations in the process should be recorded in the batch records. Any changes can be modified according to the Good Record Keeping protocol and documented in the change sheet of the batch record or updated in similar documents.
