Part 2 Good Manufacturing Practices for Pharmaceuticals
Chapter 2 Good Manufacturing Practices for Chinese Herbal Medicines
Section 5 Organization and Personnel
Quality control departments and manufacturing departments at Chinese herbal medicine factories shall be established separately.
A person shall be placed in charge of each Chinese herbal medicine factory department, and sufficient personnel shall be assigned to carry out and supervise the manufacture, processing, re-packaging, packaging or storage of each product.
The person in charge, supervisors and employees of each Chinese herbal medicine factory department shall all possess suitable educational backgrounds, and shall all undergo practical training in implementing the rules prescribed in Part 3 of this set of Standards; Microbiological testing personnel shall receive specialized trainings.
Chinese herbal medicine factories shall establish in writing sanitary standards for employees; the standards shall include the following items:
(1) Regular health examinations in accordance with the nature of the employee’s job;
(2) Measures to prevent employees with illnesses or open wounds from having a negative impact on pharmaceutical safety or quality;
(3) Rules requiring employees to wash or disinfect their hands when entering work areas, refrain from wearing jewelry, eating, drinking, smoking, or engaging in any other behavior that may impact sanitation in manufacturing areas;
(4) Standards for the types of work clothes, hoods, face masks, gloves, arm covers, and shoe covers for each job.