QUALITY SYSTEM
Dedicated to delivering the highest quality products
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.
QMS Governing structure
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.
Application of QMS
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:
Robust quality and regulatory support
Through years of operating as a CDMO, we have established a robust quality management system, with collective experiences in numerous key areas:
Technical Transfer, including Process and Analytical Method Transfer
Our technology transfer activities include both technology and knowledge transfer of the product, manufacturing process or analytical methods throughout R&D and manufacturing stages.
The methods can be transferred between different manufacturing sites, as well as from clients to Porton Advanced.
We have established robust Technology Transfer procedure, based on planned and controlled transfer activities, which enable us to obtain products and analytical methods that meet clients’ requirements.
Purchasing, Import and Export Support
Our robust procurement process clearly defines the procurement of materials and related services required for development and manufacturing operation activities. This ensures that the purchased materials or services are of high quality, are traceable, and that suppliers can provide reliable and accurate input and value-added services.
Our import and export processes ensure that our import and export activities are compliant, smooth, and ensure the timely delivery of special goods, including microorganisms, human tissues, biological products, blood and its products, and biological materials of animal resource.
The established procedure also defines the documents required for customs inspection and related processes.
Global CMC Registration Support
Our registration team have many years of global regulatory experience, such as with ICH, FDA and EU registrations. We also have established eCTD templates for IND and BLA registration.
We are able to provide:
• Registration Service Consultation
• Provide preparation of Chinese/FDA/EU IND&BLA
• CMC application document service
• EU IND/BLA and regulation support
• Chinese IND/BLA and regulation support