Quality Control and Quality Assurance of GMP
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Quality Control and Quality Assurance of GMP

BOC Sciences adheres to the concept of quality first and customer first, and gives full play to the role of quality control and quality assurance to ensure that product quality meets the requirements of high quality. Our quality department can be divided into two parts, one is quality assurance, responsible for policy control. The other is quality control, responsible for technical control.

Why Do We Need Quality Control and Quality Assurance?

Quality control and quality assurance are the key links in the production of enterprises to ensure that products meet the intended purpose, and play a vital role in the quality of product production. The management of product quality ensures the safety, effectiveness and quality of products, and ensures that all products meet the quality requirements. Strict control of potential hazards in aspects involved in production, such as inspection of materials, intermediate products, products to be packaged, factory inspection of finished products, equipment, personnel, and laboratory testing, is the basic condition that enterprises must meet.

Our Quality Assurance

Our GMP grade amino acid, peptide, PNA monomer and resin products are manufactured under the supervision of professional quality assurance personnel. Our GMP operations strictly adhere to our comprehensive quality management system to ensure product quality in compliance with global quality policies.

  • Standard operating procedures in compliance with quality policy

We have a strong integrated quality management system and have developed a set of standard operating procedures in line with our quality policy to ensure that GMP operations operate within the guidelines of the standard operating procedures. We deliver excellent products and services to high standards and at a high level.

  • Certified clean room

Our advanced GMP clean room area isolates the upstream and downstream processes of product manufacturing, greatly reducing the risk of cross-contamination.

  • Customized product specifications and analytical methods

We produce amino acids, peptides, PNA monomers and resins according to quality regulations. With a wealth of professional knowledge, we tailor-made products of specific specifications required by customers according to the intended use of the products.

  • Good manufacturing practice

Our synthesis laboratory is equipped with advanced synthesizers, which can easily realize the synthesis of standard amino acids, special amino acids, highly modified complex peptides, PNA monomers, and resins for solid-phase synthesis. Our products are manufactured under strict quality management system and are of high quality.

  • Comprehensive batch records

All GMP manufacturing operations are documented in comprehensive batch production records, ensuring products meet specifications.

Our Quality Control

We pre-determine product attributes and their acceptance criteria, ensuring that the final GMP-grade product meets requirements.

We strictly implement release testing and environmental control testing, and conduct comprehensive quality control testing and characterization of the final product. We perform method development and validation according to customer requirements, performing validated analytical methods, stability tests and robust degradation.

Our quality control offers a variety of optional testing methods, including appearance, molecular weight, sequence analysis, purity, enantiomeric purity, assay, water content, bioburden, toxins, residual solvents, metal content and more.

Examples of some of our quality control testsExamples of some of our quality control tests

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