Microbiology Gap Analysis
Mock FDA Audits
External mock audits offer several advantages for a company. First of all, the incoming inspection team is experienced in auditing a wide range of different companies, event different industries, and so can offer confidential insight into potential compliance weaknesses in your system. Secondly, being external CGMP audit experts they are not subject to the constraints internal company experience might place on an internal team. Finally, the turn-key nature of an external team offers rapid scheduling and reporting of CGMP compliance. If your need is for a GMP audit in the related pharmaceutical industries, medical device or personal product industries we can help make internal and external lab CGMP audits an effective means to ensure compliance and to train your personnel.
Compliance has to make sense from both a scientific and a business perspective.
Facility Audits
The network of experts at Microbiology Network excel at systems-based facility GMP audits. Our expert comprehensive review balances the time on-site, report of findings, and if needed, corrective action SOLUTIONS that will assist the client is a successful inspection. This cost-effective direct approach helps our clients experience a successful inspection and license. By using a structured review of the production facilities, utilities, validation, testing and other manufacturing documentation, the PAI Team makes the most efficient use of on-site auditing, report writing, and if requested, corrective actions.
Take advantage of the extraordinary breadth of skills offered by this experienced team with seasoned, proven advice.
Regulatory and cGMP Compliant Document Review and Preparation
Whether it’s a regulatory submission, environmental monitoring program, or cleaning validation protocol, the Microbiology Network can provide quick, expert review of your program documents to ensure the most current regulatory compliance is applied. Years of personal experience ensure that documents submitted to the FDA are of the utmost quality — helping to improve the chances for a smooth and rapid product approval.
Audits and Reviews
Leveraging our extensive experience in compliance, science, and technology, our network of experts can perform a wide variety of audits and reviews of good practices for drug and device manufacturing, laboratory management, marketing and promotion, and more.
Due Diligence Audits
In addition to working directly with pharmaceutical, biologic, medical device, and dietary supplement companies, the Microbiology Network delivers support to venture capital firms or other companies seeking acquisition of technology, products in all phases, facilities, businesses, and other assets. The Microbiology Network provides cost-effective reviews of program compliance and milestones.
Preparation for Pre-approval Inspections
Pre-Approval Inspection (PAI) Preparation services are offered by a collaboration of experienced, independently successful GMP consultants. The team assembles the requisite skill sets for the particular job and can handle the largest facility audit or the start-up who wants a quick review prior to the Agency visit.
Microbiology Lab Operations
The Microbiology Network can handle all QC laboratory consulting needs. Our experts have extensive experience in:
Lab Design
With decades of experience in industrial applications, our consultants wrote the book on QC microbiology lab design. Use our expertise to help design and build your lab, or refine the existing facility.
Lab Management
The Microbiology Network consultants are all established leaders and consultants in the pharma-related industries. Use our expertise in training your lab management, or in assisting in getting the lab on a strong track for compliant science. We wrote the book on QC Microbiology.
Lab Investigations
Microbiology lab investigations are difficult and rely on an in-depth understanding of the GMPs, the process, methods used for QC testing and the science of microbiology. Critical to this effort is adequate proactive documentation. Let us assist in setting up your systems to allow for efficient investigations using a solid, proven approach.
SOP Structure & Generation
The establishment of a strong SOP system is critical to the success of the lab and the reliability of the data generated by that lab. Consistent data interpretation, comprehensive training program results, valid test designs all rely on the adequacy and completeness of the SOP system. Beyond this, a defensible rationale for policy decisions may make the difference between successful audits and 483 observations, or worse, Warning Letter citations. Let us assist your facility in review of your SOP system design for compliance and scientific completeness:
GMP and Technical Training
Supplement your training program with in-house courses specific to your needs. Alternately, contract for a specific webinar course for your specific needs. Whatever the level of your training situation, the Microbiology Network can provide a specific and appropriate solution.
