Implement the whole process of GMP implementation and supervise and check the implementation of GMP. Mainly responsible for supervising and guiding the implementation of GMP in all departments of the company, including the monitoring and control of the whole production process and the monitoring and management of materials and common systems, and the handling of deviations, abnormalities and change control of starting materials and production processes.
QA is responsible for production process and production elements, people, machines, materials, laws, rings for comprehensive supervision and management, and accurate records, providing reliable basis for product quality evaluation. For the starting material, the intermediate product is strictly quality control, which is due to be released. The release of the finished product is subject to strict quality evaluation, both conforming to the quality standard, and confirming that the whole production process meets the GMP requirements, no cross pollution, error, confusion, review, the quality manager further confirms, and can be released in the back of the audit sheet. QA is also responsible for the establishment of various product quality records, responsible for the collection and preparation of various quality information, and the quarterly quality analysis will be held by each quarterly organization, and the problems existing in the production and quality management are timely corrective, and the quality management and production management are in conformity with GMP requirements.
After more than 30 years of development, we have a perfect quality system and a professional quality management team. Hawk Bio. has licensed the drug production license, completed the API registration of the CENTER FOR DRUG EVALUATION, obtained the CEP certificate issued by EDQM, the ND number issued by the ministry of health of the Russian ministry of health, and completed the registration of the Brazilian anvisa, through the ISO 9001 quality management system certification, KOSHER and HALAL certification. Hawk Bio. has an independent quality control center, equipped with advanced testing equipment, which aims to provide the best products and the best service for domestic and foreign customers.
QC: Responsible for the inspection of starting material, intermediate product, finished product and retention sample observation. According to the national pharmaceutical standards, QC has prepared the quality standards and inspection operation procedures for all kinds of raw and auxiliary materials, intermediate products, packaging materials, finished products, sampling procedures, sample observation procedures, standard solution management procedures, laboratory management procedures, etc.
The Inspectors are able to perform inspections according to the operating procedures, fill in inspection records and inspection reports in a standardized manner, be true, timely and accurate, and be responsible for the inspection results. The inspection record should be filed and kept for a long time. QC assign special person to observe the sample retention of the product to check the stability of the product.
