The Microbiology Network was established in 1996 and provides quality assurance consulting, training and expert witness services to industry. The goal of the Microbiology Network is to provide your company with the tools needed to develop internal expertise and strengthen procedures that will improve the company’s ability to profitably meet the challenges of today’s changing regulatory climate. Our quality control/quality assurance consultants provide consulting, training and mentoring your personnel within the culture and expectations of your company to meet regulatory expectations. Come to the Microbiology Network for assistance and direction in problem solving and building internal expertise.
The Microbiology Network is comprised of subject matter experts with international reputations:
- Anne Marie Dixon – Clean rooms and personnel management
- Karen McCullough – BET and Quality Professional
- Leonard Mestrandrea, Ph.D. – Non-sterile contamination control
- David Porter, Ph.D. – Compendial issues
- Scott Sutton, Ph.D. – QC Microbiology, Contamination Control, Quality
- Robert Westney – QC Microbiology Lab Operations
Specific Consulting Services:
- Quality Assurance Reviews
Experts in documentation practices, EM trending and facility qualification and CMC review of the Common Technical Document we can provide a “new set of eyes” or additional resources for your Quality organization.
- Mock (FDA-style) Audits
Audits ranging in scale from an individual lab (internal QC or contract) through corporate level audits of manufacturing facilities. The network of experts in the Microbiology Network can handle all audit needs for your company.
- Investigations (Finished product, in-process, EM)
We will assist in conducting an investigation into existing issues whether they be finished product tests such as Sterility Test failures, Antimicrobial Efficacy Test failures (or other finished product tests), in-process bioburden excursions, or excursions of the Environmental Monitoring program or trends. We will direct the enhancement or development of a system to approach future investigations of a microbiological nature (if such is needed). Our approach focuses on the laboratory data and determination of the validity of the microbiological testing underlying the investigation. The strengthening of existent systems is key, with proactive, CGMP documentation of assays central to successful investigations, identification of root cause and CAPA.
- Objectionable Organisms
One of the most controversial areas in non-sterile product manufacture is the role and identification of “Objectionable Organisms” in the product and the manufacturing process. We will conduct a proven analysis of your process and products to develop a system geared toward manufacture of safe and profitable product.
- EM/Facility Qualification
The establishment of and environmental monitoring program as part of the manufacturing facility qualification is a specialized task and one that drives the routine EM program for years to come. Whether an aseptic facility, a sterile facility or one producing non-sterile products, the EM program is one that will be under intense scrutiny for years. It is critical to set this up correctly and use the qualification program to build a compliant program (while keeping an eye on the bottom line).
- QC Microbiology Lab
Establishment of the QC Microbiology lab requires a broad understanding of microbiology and experience in the workings of the lab. A good source document for this approach might be the book “Pharmaceutical Quality Control Microbiology: A Guidebook to the Basics” by Scott Sutton. We wrote the book on the QC microbiology Lab and can serve to audit the external lab, enhance your internal lab procedures, design and build the lab, or serve as a “virtual Microbiology Department” handling all microbiological testing (at external, qualified labs), data review and report generation. With the Microbiology Network in charge of the QC microbiology for your facility you have a proven, steady group of subject matter experts looking out for your interests. When the time comes to bring the work in-house, our training staff leads the industry in state of the art training methods and subject matter.
- Project Management
The Microbiology Network can serve as a project management resource with subject matter expertise in contamination control and product development. With a proven track record in process redesign, product development and successful product registrations, the Microbiology Network can assist in project management (MS Project)with emphasis on the technical projects.
- Rapid Microbiological Methods
Established track record in RMM – come to the Microbiology Network for a sober evaluation of currently available technologies in your regulatory environment. We will not “over-sell” capabilities or possibilities but will tailor the “desired” to the “possible”. There are many potential applications possible – we help you to determine which make business sense.
- Expert Witness
Contact the Microbiology Network for more information.
The Microbiology Network has a track record helping pharma, personal products and medical device manufacturers from start-up through major multinationals. With clients world-wide, the Microbiology Network stands ready to assist with questions of contamination control, finished product quality or regulatory compliance in all areas related to bioburden or microbiological issues. Smaller clients might also be interested in the assurance provided by having the Microbiology Network serving as their “virtual microbiology department” ensuring compliant operations.
Our webinars focus is QC microbiology in the regulated industries. These webinars range from applied topics geared to solving problems and questions at the bench, to academic presentations of current research for your continued development. We try to being meaning to the phrase “science-based regulation.”