Quality & Regulatory
QA & QC

As a one-stop CDMO in the field of biopharm science, Thousand Oaks Biopharmaceuticals Co., Ltd. has a quality management system fully in line with the regulatory requirements of China NMPA, EU EMA, and US FDA. Our robust, well-functioned Quality Assurance (QA) and Quality Control (QC) Departments are responsible for the establishment, implementation, maintenance, and supervision of the quality system.

QA

Thousand Oaks Biopharmaceuticals Co., Ltd. has a quality system comprising of documented management files at all levels. We will win the trust of customers with excellent products and services.

Our files consist of:
  • Quality manual
  • Standard management procedures
  • Standard operating procedures
  • Standard technical procedures
  • GMP records (including batch production records and inspection records) and records that directly or indirectly affect product quality
  • External documents, such as regulations, standards, guidelines and books of related fields



QC

We have a comprehensive GLP/GMP quality system and implement quality control in accordance with the regulations of NMPA, FDA, EMA, and ICH, including:

  • Monitoring of utilities (such as water system, process gas, etc.) for production in line with GMP
  • Environmental monitoring
  • Analysis of raw materials and excipients
  • Validation and verification of analytical methodology
  • Release control and analysis of in-process products (IPC), intermediate products and final products in the production of drug substance and drug product
  • Biochemical analysis (HCP, DNA, Protein A, biological activity, binding activity, etc.)
  • Physical and chemical tests (appearance, pH, conductivity, osmotic pressure, molar concentration, fill volume, visible particulates, subvisible particles, UV protein content, etc.)
  • Instrument based analysis (glycosylation analysis, sialic acid analysis, peptide map, SEC, CEX, total oxide, polysorbate 80 / 20, titer, excipient content in preparation, etc.)
  • Microbiological test (sterility test, endotoxin test, microbial limit test, etc.)
  • Cell bank test
  • Reference standard test
  • Stability study