Ding Yong，Senior Production Manager, Guangzhou Yudong Health Pharmaceutical Co., Ltd. of Harbin Gloria Pharmaceutical Group

Topic: Analysis of Risk Assessment Points of Collinear Production of Oral Solid Preparations

Speaker Bio 

More than 10 years of working experience related to pharmaceutical factory production and quality management, familiar with on-site quality control over preparations like oral solid preparations, sterile powder injection and external ointments etc. Involved in many plant construction projects; played a key role in the whole process of plant design, layout, validation and certification for solid preparation and freeze-dried powder injection etc.Familiar with relevant domestic and foreign GMP laws, regulations, guidelines; organizing quality system formulation; designed and developed pragmatic and applicable quality systems from GMP documentation, validation, changes, deviations and laboratory management etc.

Presentation Summary

With the continuous development of the pharmaceutical industry, companies hope that product manufacturing can quickly go to the market under the basic requirements of meeting product quality requirements, regulatory requirements, and saving production and operating costs. The characteristics of the production process of some dosage forms, such as the complex composition of the drug, the large amount of dust produced during the production process, and the difficulty of cleaning, especially the uncontrollable accidents, may cause cross-contamination. Such as dust, gas, vapor, aerosol, genetic material or active material, etc., all increase the difficulty of risk assessment of drugs with shared production lines.

This subject starts from the premise, facilities and equipment, takes production planning, material management and personnel management as the starting point, and carries out risk assessment on the products with shared production lines according to the principle of risk management. Focus on solving the problems in actual implementation, such as product mixture, product residue, transport operation, air particle transmission, cleaning verification, etc. to realize more economical and rapid production of various dosage forms and products with various specifications, and further improve the ability of quality control in drug production.