Menovo Pharmaceutical：A EHS reliable CDMO partner for your APIs

 

Recently, Menovo Pharmaceutical had one of its sites successfully audited by a PSCI member. The Pharmaceutical Supply Chain Initiative (PSCI - https://pscinitiative.org/) is a group of pharmaceutical and healthcare companies who share a vision of better social, health, safety and environmental outcomes in the communities where we buy. With 5 cGMP inspected sites (4 for API manufacturing and 1 for finished oral dosage forms), Menovo got its EHS system’s compliance status reconfirmed.  The Anhui Menovo Pharmaceutical EU-GMP inspected and ISO14001 certified site, located in an Industrial Park in Guangde city, a safe region that has not experienced any natural disaster in the past 50 years, is dedicated to the manufacturing, quality control and storage of APIs and Intermediates for Human and Veterinary medicines. The ring-fenced site has 24/7 security CCTV surveillance and controlled access in key areas. The site has received several EHS awards (such as safety standard level 2 and greener production site) and has a clean compliance record, without a single fine or violation notice for more than a decade. Such unblemished performance is the result of a strong EHS culture, supported by policies and procedures, training and continuous improvement and assessment of ongoing compliance with Health and Safety, Environment, Business Ethics and Labor Regulations. This culture is also extended to our suppliers, through a purchasing policy that guarantees alignment with sustainable procurement principles and responsible business practices.

 

On the long-term, Security of Supply is guaranteed by the Business Continuity Management procedure, which compiles the risk management plans by 15 different business functions, complemented by dual sourcing strategies and supplier safety periodic evaluations, renewal of environmental and operating permits, evaluation of major facility dependencies, etc. Just like in process and equipment change control,  HSE, ethics, labor and organizational changes are all covered by change management procedures.

 

Business Integrity and Fair Competition Policies are part of every employee onboarding handbook, including codes of conduct regarding anti-corruption practices, privacy obligations and investigation of employee concerns.  Menovo’s labor policies clearly prohibit child labor, forced labor and any kind of discrimination or harassment. Besides freedom of association and freely chosen employment, the company sets its wages and benefits according to HR policies and individual labor contracts, including voluntary and paid overtime, vacations and parental and sick leave terms.

 

 

Our Emergency Preparedness and Response systems include emergency response plans, reviewed by external experts and approved by local authorities, fire and smoke detectors in raw material warehouses, flammable liquid storage tanks and waste storage areas and two large water tanks, for fire protection, with over 1,200 m³ capacity, just to name a few. The fire-fighting control room team is trained and officially certified and monitors the fire alarm system 24/7. Our volunteer fire brigade teams conduct regular training and participates in the annual fire drill with the professional fire brigade and local authorities.

 

 

 

Because Health and Safety matters, we set and review Health and Safety objectives, recording and investigating accidents, incidents and near misses, providing and documenting EHS training to all new employees and refresher training to everyone else. We promote safe behaviors, provide adequate sanitary and hygienic facilities and fresh potable water to all employees. We have no dormitories on site and provide adequate safety and personal protection equipment (PPE). Before introducing new products or process changes, we perform SDS evaluation, PHA and HAZOP safety assessments and thermal runaway risk-assessment, through calorimetry studies using DSC, RC1 and ARC. Outcomes are translated into actions, investing and implementing engineering safety systems. We conduct dust safety testing and operate flammable liquids, vapors, powders and gases under inert conditions (nitrogen and degassing), with electric grounding and in ATEX areas, with regular maintenance inspection of the safety systems. Electric work, welding, heat and confined space operations, require documented authorization and supervision. External maintenance and other subcontractors are pre-approved, trained and regularly checked. Equipment safety and protection systems, such as guards, wheel chocks, dock locking, etc. and sensors like oximeters are subjected to periodic checking. Occupational Health and Industrial Hygiene plays and important role in the protection of our teams. OELs and exposure risk assessments are performed for our APIs and raw materials, with exposure monitoring of solvent vapors, noise, pharmaceutical powders as well as low oxygen atmospheres and working ergonomics. We post these results in the workplaces and perform risk-based medical testing to guarantee the surveillance of our employees’ health. We invested in powder transfer systems, hard and soft isolators and local exhaust ventilation systems. First Aid training is in place following standards of local Red Cross.

 

Menovo’s Environmental commitment, to effectively treat and control emissions and continuously improve performance, is expressed in our Environmental Policy and demonstrated by our renewed environmental permits, awards and patented environmentally friendly processes. Our site Environmental Impact Assessment (EIA) includes the impact assessment of our operations in the surrounding community. Our operations are designed and executed to avoid pollution, comply with legal requirements and to reduce consumption of water, energy and other natural resources. The company has adopted management procedures on PIE (Pharmaceuticals in the Environment) based on PSCI Principles. Our process water is pre-treated using state-of-art procedures, including catalytic Fenton oxidation (minimizing sludge production), biologically treated, sedimented and sent to the Guangde #2 sewage treatment plant for further treatment. Modern scrubbers are used to treat gaseous emissions from both the workshops and waste treatment units. We’ve invested in emergency collection tanks and tank farm containment and keep our warehouses and storage areas in good conditions, with fire prevention and fire-fighting systems in place. At Menovo we aim zero accidents and 100% compliance.