QA: Quality Assurance

Capot is committed to ensuring product quality meets the ISO9001:2015 standards and considers GMP standards an extension of quality assurance to ensure our quality management system is more comprehensive, rigorous, and professional.

To this end, we have established a strict quality assurance system that includes the following activities and responsibilities:

• Formulating and validating agreements to ensure compliance with qualification standards for release;
• Issuing various documents, such as specifications, master batch records, standard operating procedures, etc., to ensure accurate transmission of information;
• A robust batch review, release, and archiving mechanism to ensure timely release and proper archiving of batch records;
• Strengthening change control, deviation control, and investigation mechanisms to ensure stability in the production process;
• Approving validation protocols to ensure the effectiveness of each validation activity;
• Focusing on employee training to enhance the team's professional level;
• Conducting regular internal audits and compliance reviews to ensure the smooth operation and compliance of the system;
• Strict supplier qualification reviews and audits to ensure the quality of the supply chain is controllable;
• Professionally handling claims, recalls, etc., to protect customer rights.

QC: Quality Control

In the laboratory and production workshop, we integrate ISO9001:2015 and GMP standards into our quality control system to ensure that every batch of products meets the high standard requirements of our customers.

Activities and responsibilities include:

• Developing and approving high-standard specifications to ensure product design meets the highest standards;
• Conducting strict sampling, analysis, inspection, and release of raw materials, intermediates, and cleaning samples to ensure product quality;
• Precise sampling, analysis, inspection, and approval of finished products to guarantee the qualification of every batch;
• Focusing on the maintenance of qualifications and equipment to ensure the normal operation of laboratories and production facilities;
• Professional method transfer and validation to ensure the controllability of the production process;
• Approving documents, such as analytical procedures and standard operating procedures, to ensure the standardization of the production process;
• Stability testing and stress testing to ensure the stability and reliability of products under different conditions.