Quality system

Dedicated to delivering the highest quality products

Our Quality Management System

Our Quality Management System (QMS) ensures that all of our GMP manufacturing activities comply with global regulations. This includes regulations from the FDA, EMA and CFDA in raw material and supplier control, manufacturing control, data integrity and control, GLP and GDP, etc.

Our GMP facilities, equipment and personnel are closely governed, monitored, and documented, to ensure that we can provide the best support to our clients throughout all stages of development and commercial production.

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Quality
System

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Governing
Structure

QMS Governing structure

Our carefully constructed core QMS governing structure consists of a quality manual, quality policy, SOPs and records, forms, protocols and reports.

The quality manual is the highest-level document in Porton Advanced’s quality system. It governs the rest of the levels of quality document. In the case of a conflict, the quality manual prevails unless otherwise stated. The quality policy describes the management strategy for different aspects of the QMS, derived from the 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.

Applying the QMS

The QMS regulates all our operations and should be applied as appropriate to all projects and products at all stages.

The QMS guides:

  • Management responsibilities
  • Resource requirements and management
  • Personnel/Human Resources management
  • Material management and control
  • Facility and Equipment management and control
  • Control Outsourced Operation control
  • Work Environment control
  • Manufacturing Operation control
  • Project management
  • Instrument maintenance
  • Cleanroom
  • Nonconformance investigation and continuous improvement
  • Quality Control Testing Management

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:

Process and analytical testing method tech transfer

Our technology transfer activities include both technology and knowledge transfer of the product, manufacturing process or analytical methods from throughout R&D and manufacturing stages.

The methods can be transferred between different manufacturing facilities, as well as from clients external to Porton Advanced.

We have established robust technology transfer procedures (SOP-SZCC-0047; SOP-SZQC-0048), built on planned, controlled transfer activities, which enable us to obtain products and analytical methods that meet the requirements of our clients.

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 (CL-SZPP-0001; CL-SZPP-0002) 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:

  • IND/BLA Support
  • FDA IND/BLA and regulation support
  • EU IND/BLA and regulation support
  • Chinese IND/BLA and regulation support
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