There are many benefits to adding highly potent drug products to your portfolio, including increasing demand and generating potentially higher profit margins. Making the decision to incorporate highly potent drug products into your manufacturing facility can be a challenging process.
Food and Drug Administration and other regulatory agencies will focus on cross-contamination with other drug products, operator safety and environmental exposure during receiving, sampling, testing, manufacturing unit operations, cleaning, labeling, packaging and storage. In order to capitalize on this market and introduce highly potent compound drugs into an existing facility, consider these core elements:
Develop corporate guidance to safely manufacture highly potent drug products.
1. Create corporate guidelines for the manufacturing of highly potent drug products—what corporate guidelines are in place for the handling of highly potent drug products?
2. Create an occupational exposure limit (OEL) banding system—generate an OEL banding system that provides required engineering controls for unit operations based on OEL ranges and develop tools to evaluate and measure exposure.
3. Develop a work practices document—generate a work practices document that establishes best practices for facility design, manufacturing unit operations, laboratory tests, cleaning, waste disposal and storage.
Conduct a facility and process risk assessment.
4. Execute ICH-Q9 failure modes and effects analysis (FMEA)-based risk assessments—conduct an ICH-Q9 FMEA-based risk assessment for the manufacturing products that include highly potent drug compounds to cover cross-contamination, operator exposure and environmental exposure.
Develop equipment requirements and standard operating procedures.
5. Generate detailed site surveys—conduct a detailed survey of existing facilities and unit operations that are intended for use with potent compounds. Describe each unit operation, quantity of product being handled, product characteristics, duration of task, frequency, current engineering controls and personal protective equipment.
6. Develop a facility-based user requirement specification—generate a facility-based user requirement specification that describes the highly potent drug products, capacity/throughput and manufacturing unit operations.
7. Develop a process-based user requirement specification—generate a process-based user requirement specification that entails all unit operation and product handling operations; from initial receipt of materials through manufacturing, packaging, cleaning, quality control and final release.
8. Develop comprehensive standard operating procedures (SOP)—based on the risk mitigation plan outputs of the risk assessment, develop SOP for all product handling and unit operations with a focus on product quality, patient safety, operator and environmental safety.
Develop education and training programs.
9. Initiate education and training programs—establish a training program to communicate, educate and train employees on the corporate guidelines for the handling of highly potent drug compounds. This should include gowning, manufacturing unit operations, engineering controls, cleaning and waste-handling practices.
Develop EHS sampling program.
10. Establish an environment, health and safety (EHS) particulate sampling program—set up an EHS program for ongoing sampling to monitor the handling and manufacturing practices for highly potent drug products.
Deciding to manufacture highly potent compound drug products in your facility is a significant decision that requires planning and budgeting to determine if the operations can be safely integrated and separated from non-potent unit operations.
The core elements described above are intended to help you capitalize on this market and introduce highly potent compound drugs into an existing facility.
Remember, risk assessments help determine how to prevent cross-contamination with other drug products and protect the operators and the environment and corporate guidance will set the stage for communicating and training the workforce. It is imperative that the EHS develops and implements a sampling program that will monitor containment performance to determine if the engineering controls, administrative controls and SOP are being implemented correctly.