SAFC’s Verona plant has just been awarded SafeBridge Certification. But what does this mean, and what does the process involve? SafeBridge President and Chief Executive, John Farris, tells all in the following interview with SAFC Live.
SAFC Live: Hi John. Could you start by telling us a little about SafeBridge?
John: We are a group of senior occupational health professionals and analytical chemists, all of whom used to work in big pharma companies. We founded the company back in 1997 as a group of environment, health and safety professionals from Syntex Corporation in the San Francisco Bay area. We opened a second office in New York City in 2004 with people from Pfizer and Warner Lambert, and then opened a further office in Liverpool, UK a year later. We have about 20 consultants and analytical chemists who carry out potent compound safety and risk assessment services for the pharmaceutical, biotech and fine chemical industries.
SAFC Live: What is SafeBridge Certification?
John: It certifies that a company is competent in the safe handling of potent pharmaceutical compounds. It covers four broad areas:
- Program management
- Hazard Identification and Evaluation
- Hazard Control
- Communication, Education and Training (CET)
Around 60 criteria are spread across these four areas and are weighted according to their relative importance. For example, program management is weighted at 10%, hazard identification and evaluation 20%, hazard control 50% and CET the remaining 20%. The benchmark is to meet the level of standards routinely in use at big pharma companies. As well as the facility features and containment hardware, it is also important to have full commitment from top management, with budgetary support, a strategic plan, and all the necessary technical skills either inside the company or via consultants. There has to be a hazard assessment process so that compounds are properly evaluated in order to determine that the necessary controls are established ahead of time, and also written standard operating procedures that the workers are trained in.
SAFC Live: How do you go about assessing a facility?
John: At first we try to get to know the company and assess whether they are actually proficient or just learning when it comes to handling potent compounds safely. We are happy to work with the companies who are new to this area to help them improve, but a full assessment would not be an effective use of time and money at this stage. When we come to carry out an assessment, two of our occupational health professionals visit a site for two or three days and study the facility itself and its containment and control equipment, and the softer aspects such as management systems, their ability to evaluate hazards, measure exposures, and their communication and training procedures. We delve deeply, and arrive at a score for each of the 60 criteria, which are listed as statements rather than questions.
A score of 80–100% means the statements are “almost always true”, an assessment of “routinely true” scores 69–70%, “somewhat true” or needs improvement is given between 21 and 64%, and if it is “almost never true” or non-compliant, it scores between 0 and 20%. The weighting system is then applied, and we come up with an overall score. To gain Certification, they must have an overall average of 65%, with no scores below 55%. This initial Certification is good for two years, and in the intervening year the company must carry out a self-assessment (note: This applies to North American and European facility locations. Facilities outside these geographies are considered on a case-by-case basis and may have different requirements).
SAFC Live: How did the fact that Madison is already SafeBridge certified affect the assessment for Verona?
John: The two sites are on the same certificate. We assess each situation individually, and if there are two sites under the same management, as is the case for Madison and Verona, we usually fold them together into one Certification because we know those running the plant will know what they are doing. Had they been run by separate management teams, they would have been certificated separately. Most large plants, like Madison and Verona, have a section of the facility that is dedicated to potent compounds, and it is also important to note that it is only the part of the plant that handles potent drug substances that has the certification, along with the ancillary support areas such as analytical labs.
SAFC Live: What is a potent compound and what are the particular risks involved in manufacturing them?
John: When answering this, it is important to consider occupational potency, not just therapeutic potency as there are some drugs that are not as potent therapeutically but still present an undue risk to a healthy worker. The risks of these compounds include effects on the reproductive system, a developing fetus, or drugs that have “genic” properties such as causing chromosomal damage that can lead to cancer. Those whose properties are completely unknown because they are so new must also be considered potent as a failsafe. With all of these, there is a risk that workers’ health will be affected at a low level of exposure. A drug is considered occupationally potent if it has an occupational exposure limit beginning at 10 µg/m3 in air or less. As a point of comparison, the edge of visual acuity for particles in air is approximately 100 µg/m3 under conditions of bright light and good contrast. The safe level for a drug in the air with an occupational exposure limit of 10 µg/m3 is 10 times less than this, so it cannot be seen, and workers cannot tell if they are being overexposed. This is why careful precautions are necessary to prevent occupational exposure. There is also a risk to the environment with some of these drugs, such as endocrine disruptors and antibiotics. So while our focus is primarily on occupational health, we do also look at environmental control.
SAFC Live: How is the industry changing in terms of the number of potent compounds being developed?
John: Well, nobody is working on the new aspirin! Pharma companies are working on new targeted oncology drugs, drugs for unmet health needs, compounds that are very specific and targeted, and active at very low doses. The lower the dose, the lower the chances of side-effects, and the more long-lasting in the body a drug is, the less frequently patients have to take it. While these are great therapeutic characteristics for patients, they do mean you have to control exposure in the workplace to lower and lower levels. This is a clear trend that has been going on for several years as there have been a higher percentage of potent drugs in development and on the market.
SAFC Live: What are the additional challenges facing CMOs who make many different products?
John: The first one is to have a system for critically evaluating the health hazards of each product customers bring along. Often times these are products they did not develop themselves. Big pharma companies will have worked with a compound for many years before it gets scaled up and have a good idea of the hazards it presents, but for a CMO it is completely new and unknown. A company must also be candid about what it can and cannot handle. Smart companies realize that they can handle certain things because of the controls and procedures they have in place, but they may not have the additional level of control that they would need for others. This can help CMO’s in the decision making process when evaluating requests for compounds they are not qualified to handle. The challenge for a CMO is to keep the plant productive and with a pipeline of incoming products, which means making a lot of decisions about what they are and are not going to take on. I believe that by working with us, companies have seen significant advantages to their businesses by taking a systematic approach. If you were to talk to the people in Madison, you would find they have seen a continuous improvement in their programs and processes since they have been involved with us. They have also been able to influence the other parts of the organization in a positive manner.