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Consulting Services

Mock FDA Facility and Lab Audits

External mock audits offer several advantages for a company or pharmacy. 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.

Audits are available for laboratory, facility, pharmacy or 503B concerns. 

 

Bioburden Contamination Control

 

Development of a contamination control plan is critical to the success of aseptic, terminal sterilization and non-sterile manufacturing facilities.   Microbiology Network can provide a team of consultants, each expert in planning and executing an effective contamination control plan to address potential issues in your sterile or non-sterile manufacturing facility.  This plan can help provide a consistent approach and rationale to one of the most frequently-cited area of GMP compliance.

 

Environmental Monitoring for Sterile and Non-sterile Manufacturing

Recent regulatory changes have resulted in some confusion in how to conduct compliant environmental amonitoring programs which will also serve the business needs of the company.  Developing expectations for those industries regulated under 21 CFR 211 and 21 CFR 610/612 for aseptic manufacturing, terminal sterilization and nonsterile manufacturing are difficult enough.  However, adding to this are concerns over compounding pharmacies (USP <795> and <797>) and 503B Outsourcing Facilities and you have a situation where regulators and industry are trying to sort out the best program for a given situation.

Let the experts at Microbiology Network help you develop your monitoring system to be defensible and appropriate to your facility needs.

 

Microbiology Laboratory Operations

Microbiology is where we began.  Call on the Microbiology Network to assist in all training, corrective action, investigations and laboratory design questions.

We are simply the best in handling microbiology questions in a pragmatic manner.  We are not the cheapest, unless you include the cost of vague recommendations, lost time, wasted resources and false starts.  Contact Microbiology Network for clear, practical recommendations for your questions on Quality and CGMP concerns.

 

Objectionable Organisms

There is a great deal of interest in the topic of "Objectionable Organisms" in the regulated industries.  A central question in this topic is "how do you determine if an organism in your product is objectionable?"  This has been a source of concern for years in the pharmaceutical and OTC sectors.  Now it is becoming a source of concern for cosmetics manufacturers, personal care products and even compounding pharmacies.   

The Microbiology Network has several national experts in non-sterile Quality Control (QC) microbiology.  Let us help you come to a focused policy on objectionable organisms and procedures to meet your business needs.

 

Alternate Microbiological Methods

The use of rapid microbiological methods (RMM) is one that has been popular in conferences and the pharma literature for over 30 years.  However, this popularity in the speaking circuit has not been matched by a popularity in proactice for pharma, OTC, personal care products or medical device manufacturers.   There are many contributing factors to this slow adoption, but chief among these an over-optimistic expectation for the capabilities and returns on the RMM investiment from a corporate perspective.

Let the experts at Microbiology Network, Inc. help you sort through the marketing hype of vendors and consultants alike to provide a pragmatic approach to APPROPRIATE MICROBIOLOGICAL METHODS to meet your business needs.

 

Insourcing Laboratory Workers

Insourcing technical expertise in the pharmaceutical industry is another tool in the mix for bringing badly needed talent while minimizing risk and cost. The insourced resources can be highly skilled and experienced in their technical field, and work at the facility. However, they are not employees of that company but rather a third-party contract research organization (CRO). In addition, this staff can acquired at far less cost than full-time employees or temporary workers.

 

Compounding Pharmacy Services

Compounding pharmacies have seen a great deal of regulatory attention lately with FDA embarking on an aggressive inspection schedule that is producing multiple 483 findings.   This is directed not only at the new category of 503B Outosourcing Facilities but also at traditional compounding pharmacies operating under USP <797> requirements.

Microbiology Network, Inc. has several nationally recognized experts that can provide assistance to the pharmacy or 503B in meeting regulatory requirements with the understanding of business realities.  We can assist with:

  • 483 responses
  • Corrective actions
  • Preparation for the audit
  • Qualification of contract facilities to protect the pharmacist

Contact us to learn how partnership with Microbiology Network, Inc. can provide an extra layer of protection for your business.

 

Expert Witness

Expert witnesses from Microbiology Network, Inc. are drawn from nationally recognized practioners with experience in the Pharmaceutical, Compounding Pharmacy, Biotech, OTC and personal care products industries.  Many are ex-FDA or current members of USP.  No matter the specifics of your situation, we have someone who can provide expert witness consultation.