GMP 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.

Laboratory Audits

Quality Control (QC) lab audits are technically demanding in addition to concerns about GMP compliance.  The laboratory auditor must be aware of the peculiarities of the laboratory and how to audit for technical competence as well as regulatory compliance.  The experts at Microbiology Network have decades of experience in these audits, both internal company laboratories and external contract laboratories.  Using the latest and most relevant guidance from USP, FDA and PIC/S for these audits, our audit team will work with your company to determine your audit needs and execute them in a timely and fiscally responsible manner.

While conducting these audits, use the Microbiology Network consultants to train your internal audit team on how to look for issues in the laboratory environment.  The competent lab audit goes far beyond the CFR to prepare your lab personnel for investigations, method reviews and best current practice.  Use the QC Laboratory GMP Audit to benchmark your lab facility.

Laboratory Investigations

The first question in any potential OOS (Out of Specification) investigation involving a microbiological test result has to be “Can we trust the data?”  Use the experts at Microbiology Network to perform an in-depth investigation of the lab data behind finished product test failures, environmental monitoring or other laboratory data deviations.  We wrote the book on the topic and can provide you valuable insight into your lab operations while training your QC lab management in effective investigation techniques.

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.