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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.

Choose Capot , choose a good professional partner!

" We can synthesize and manufacture from 1 gram to 10MT or more. "

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