Protect Your Supply Chain and Speed to Market -
Conduct EHS Assessments to Assess Business Continuity and Supply Risks One

In February 2019 Rohner Chem, a Swiss contract manufacturing organization (CMO) supplying chemical intermediates and active pharmaceutical ingredients (APIs) to the pharmaceutical industry for over 113 years, was inspected by Basel's Construction & Environmental Protection Directorate (BUD).  Findings from the inspection included approximately 15 million liters of industrial wastewater that had entered the subsoil since November 2018. ?  Since they couldn't meet the regulatory requested deadlines for remediation, their customers abandoned them and they were closed by July 2019 for .
Would an EHS assessment for business continuity and supply risk have "red-flagged" this site?  Maybe.
There were indications that conditions were not optimal.  In February 2016, an explosion at the site injured two employees and damaged parts of the production facilities.  Would an EHS management system assessment have found this to be problem and "red-flagged" the company for further evaluation?  Maybe.
Most pharma companies will perform site assessments, primarily driven by Quality Assurance issues, before signing contracts with CMOs.  Quality of the drug supply is a requirement, and other project team members may participate in the process as necessary.  However, EHS (environmental health and safety) staff not always involved Due to the health, safety and environmental risks of the processes, operations, and facilities EHS participation is very important. 
SafeBridge and its affiliated companies has an experienced staff of EHS professionals and engineers with technical and practical experience in pharma and biopharma to conduct independent third-party assessments.  We can also assess the capabilities of companies to safely manufacture potent and highly potent APIs and drug products.  In addition, our SafeBridge Potent Compound Safety Certification program, has been designed to evaluate these capabilities for CMOs.  The program is comprised of 60+ elements and provides a rigorous assessment of "hardware" (containment and controls) and "software" (procedures and practices) and compares the CMO to industry standards in potent compound safety.  A SafeBridge-certified company needs to meet these standards for the drug innovator to have confidence that they are a "contender" and not a "pretender" in potent compound safety.
For more information on our capabilities to assist drug innovators and CMOs in EHS and potent compound safety facility, program and process assessments, for business continuity or due diligence, please contact Allan Ader at allan.ader@safebridge.com or Charlyn Reihman at charlyn.reihman@safebridge.com

There is Still Time to Register for 2019 Training Courses Two

SafeBridge Potent Compound Safety Boot Camp I
Shanghai, China | November 22 - 23, 2019

Click here for further information including an agenda, course content and registration form.

SafeBridge Potent Compound Safety Boot Camp® I & II
San Diego, CA | December 3 - 5, 2019

Click here for further information including an agenda, course content and registration form.
Budget for These 2020 Upcoming Training Courses 

Industrial Hygiene in the Pharmaceutical Industry
San Francisco, CA | February 18 - 19, 2020

Click here for  further information including an agenda, course content and registration form.

Practical Industrial Hygiene Exposure Assessment and Statistics
San Francisco, CA | February 20, 2020

Click here for further information including an agenda, course content and registration form.

New to Industrial Hygiene: Fundamentals
Dallas, TX | March 24, 2020

Click here for further information including an agenda, course content and registration form.

New to Industrial Hygiene: Monitoring Workshop
Dallas, TX | March 25, 2020

Click here for further information including an agenda, course content and registration form.

Potent Compound Safety Boot Camp® I & II
Arlington, VA | April 21 - 23, 2020
Berlin, Germany | June 9 - 11, 2020

Click here for further information including an agenda, course content and registration form.

Can You Handle it Safely? Understanding Potent Compounds
Philadelphia, PA | May 4, 2020

Click here for further information including an agenda, course content and registration form.


Dr. Elizabeth Vancza gave the Occupational Toxicology lecture at the American College of Toxicology's Advanced Comprehensive Toxicology course  Three

As an overview of Occupational Toxicology, Dr. Vancza's lecture reviewed the historical and regulatory timelines of the field, beginning with the first observations of occupational disease made by Paracelcus and Ramazzini and continuing through the establishment of today's NIOSH and OSHA.  
She subsequently explained the risk paradigm in the workplace, covering the three hierarchies of hazard assessment, controls, and exposure assessment, with a particular focus on the occupational toxicologist's role in each area.  
Quantitative and qualitative hazard assessment methods and documentation were discussed, along with their practical applications as well as other risk communication tools.  
She concluded with summaries of environmental/biological monitoring and medical surveillance programs, and then offered recommendations for increasing worker awareness.  


Product Safety Toxicology Support Four
 
SafeBridge has an experienced staff of Ph.D. and board-certified or equivalent toxicologists to provide technical services required to meet product safety needs of the pharmaceutical and biotechnology industries for liability prevention purposes and to meet FDA, EMA and other regulatory compliance requirements. Services provided include the following:
  1. Leachables and Extractables Toxicology Profiles and Risk Assessments - The rubber and plastic components used in medical products and devices have received increased scrutiny for potential leachables and extractables that may come into contact with drug products. SafeBridge toxicologists set permitted or acceptable daily exposure (PDE/ADE) values for these materials as a means for setting quantitative analytical targets for detecting potential leachables and extractables in drug products. SafeBridge has assisted companies seeking to evaluate product safety for Orally Inhaled Nasal Drug Products (OINDP), medical devices, injectable/parenteral products and other routes of administration by developing robust and scientifically defensible risk assessments consistent with regulatory guidance.
  2. Cleaning Limits for APIs - Health risk-based cleaning limits for product contact surfaces are developed and applied to protect product safety. In these cases, limits are developed to measure surface or rinsate levels in order to prevent potential cross-contamination in a multi-purpose plant operation. SafeBridge employs either the guidance of the International Society of Pharmaceutical Engineering (ISPE) under Risk-MaPP, or the EMA guidance on cross-contamination.      
  3. Genotoxic Impurity Toxicological Risk Assessments- SafeBridge can assist in the toxicological assessment of potential genotoxic impurities that may appear in the active pharmaceutical ingredient (API) or drug product.   Scientifically-supportable risk assessment methodologies and the ICH M7 guidance on genotoxic impurities are employed. These assessments have included assessing chemical synthetic processes, extractables and leachables, as well as potential degradants from stability testing. These evaluations have included use of in silico predictive software for determining genotoxic potential as well as recommending, coordinating and interpreting genetic toxicology testing.
  4. Impurity, Contaminant and Degradation Toxicological Evaluation - As with potential genotoxic impurities, product quality may be affected by an impurity, contaminant or degradant that may appear in the active pharmaceutical ingredient (API) or drug product.   Scientifically-supportable risk assessment methodologies and development of PDEADEs are employed to protect patients that may take the drug product.
 
The SafeBridge "advantage" is that these services are not produced "in a vacuum". All expert reports are peer-reviewed by another toxicologist. They are integrated and receive support as needed from other experts (e.g., analytical, plastic chemistry and other chemists) to provide practical and comprehensive solutions for our clients. For more information on these risk assessment services, contact Allan Ader, Ph.D., DABT at allan.ader@safebridge.com or Robert Sussman, Ph.D., DABT at robert.sussman@safebridge.com.

Come See SafeBridge At These Upcoming Tradeshows  Five

JW Marriott Desert Ridge | Phoenix, AZ | November 17 - 20, 2019
Erica Dahl, Sandra Pirela and Julia Abramov will be attending.

Sheraton La Jolla | La Jolla, CA | November 18 - 19, 2019
Karuna Sachdeva and Kent Rader will be attending.

Webinar | November 19, 2019 | 2:00 PM - 4:00 PM EST
Tracy Kimmel will be presenting on notations during the webinar.

Intercontinental Mark Hopkins Hotel | San Francisco, CA | December 4 - 6, 2019
Kent Rader and Ed Haggerty will be attending.

Surface Limits: How are they Derived and How Should they be Used in Industrial Hygiene Practice?
Webinar | December 5, 2019 | 2:00 PM - 4:00 PM EST
Tracy Kimmel will be presenting on surface limits during the webinar.

73rd Annual Northeast Industrial Hygiene Conference and Exposition
Westin Forrestal Village | Princeton, NJ | December 6, 2019
Brent Altemose, Janet Gould, Allison McCarthy, and Akash Solanki will be attending.
SafeBridge Consultants, Inc.
The premier resource for High Level Safety, Health and Environmental Support
 
Allison McCarthy
Business Development Assistant
212.727.0717 x 2407
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