Pharmaceutical manufacturing quality management standard (GMP) we are familiar with, the gradual inclusion of EHS into GMP, is the general trend.
The core of GMP, not only requires the final product to meet the quality standards, but also the whole production process must meet the requirements of GMP, the process technology management, batch/batch number management, output and material balance inspection, health management, identification management, deviation management as the focus. To any process affecting the main factors of product quality (man-machine material ring) to take all kinds of effective measures to prevent pollution and cross-pollution, confusion and human error, to ensure the safety of drug production, to ensure the quality of drugs. In May 2019, WHO published Environmental Aspects of GOOD Manufacturing Practices: Considerations for Manufacturers and Inspectors in the prevention of antibiotic resistance, including waste and wastewater treatment as GMP checkpoints. The issue of personnel protection is also rumored to be written into the new GMP. Occupational exposure level (OEB) protection, should cause the attention of pharmaceutical enterprises!
Occupational hazards caused by pharmaceutical active ingredients (API) are the key and difficult points of occupational hazard prevention and control management in pharmaceutical enterprises. Based on risk, general new drugs and highly active drugs, such as cancer drugs and penicillin, attract more attention, but general generic drugs do not attract much attention at home and abroad. The most difficult is that the “industrial hygiene (IH)” value of the active ingredient is difficult to determine and needs to start from toxicology and clinical. OEB control level is generally graded according to MSDS query results of compounds. If you do innovative drugs, you may need to spend your own money and energy to do related compound activity testing; For generic drugs, the limits and grades of the OEL/OEB can generally be obtained by querying the MSDS information of the compound. Related engineering control measures are generally divided into: 1. Open operation; 2. Closed operation; 3. Overall air supply; 4. Local exhaust; 5. The laminar flow; 6. Isolator; 7. Alpha beta valve, etc. In fact, we all know these from the perspective of GMP, but the starting point of consideration is generally from the perspective of pollution prevention and cross-contamination, and rarely from the perspective of industrial hygiene.
Domestic pharmaceutical enterprises should strengthen the protection of EHS personnel and introduce production equipment with API OEB grade matching. It is worth drawing lessons from that some European and American equipment suppliers have done quite well in occupational protection for their employees, requiring corresponding MSDS files and corresponding protection means preparation documents for the test products. In the past, when domestic pharmaceutical enterprises manufactured various products such as fine anesthesia and toxin release, OEB protection was not in place, which caused the health of many front-line employees to be affected. Under the circumstance that the legal awareness of employees was gradually strengthened, enterprises could not escape the responsibility for the corresponding occupational hazards.
Through the hazard analysis of API, the calculation formula of occupational exposure limit (OEL) is given, the API hazard classification system PBOEL is introduced, and the general rules that should be followed for prevention and control measures are put forward. In the future, we will analyze the control strategy in depth. Stay tuned!
Post time: Apr-12-2022