Services
Our goal at MicroGuard Consulting is to provide microbiology consulting services to the Pharmaceutical, Biotechnology and related Industries. Services may include review/revision/preparation of relevant policies and procedures to meet regulatory requirements, preparation of microbiology laboratory procedures and protocols, microbiological method evaluation and validation approaches, evaluation of laboratory practices and design, evaluation of microbial contamination and control strategies and practices, down-stream process contamination control , out-of-spec and aberrant data investigations, manufacturing practices for microbial control and aseptic technique, review of environmental monitoring and gowning practices, review of cleaning and disinfecting practices, training in aseptic technique and microbiology-related topics, assist in response to regulatory actions, resolving microbiological issues on regulatory actions, review and interpretation of microbiological and environmental monitoring results, setting of environmental limits and microbial product specifications, microbial stability requirements, etc.
GMP Documentation
Our industry is driven by documentation that is governed by regulations. Various documents prepared by your company translate these regulations into meaningful policies, practices and procedures that are designed to ensure regulatory compliance and product safety. Having a neutral, yet experienced third party evaluate the relevant documents, suggest meaningful changes as necessary, or prepare needed documents will enhance your overall compliance and product safety.
Microbiology Laboratory Services
Whether you have a dedicated, competent microbiology staff or outsource your microbiology testing to a contract laboratory, the services of an experienced Microbiology Laboratory Consultant can add an element of confidence that comes from participation in numerous client and regulatory audits resulting in a microbiology function that is best in class. MicroGuard Consulting’s Principal Microbiology Consultant stands ready to evaluate your overall microbiology laboratory function for best practices and performance. In conjunction with your Company’s QA audit function we can participate in audits of your contract laboratory providers, or vendors of critical materials such as media. This will take much of the burden off of your in house microbiology staff to free them up to devote their attention to care and release of your products.
OOS Investigations
Aberrant data and out-of-specification (OOS) results drain a great deal of time and energy from the existing staff. One sterility test failure puts the batch in jeopardy and may result in stock-out issues. Prompt response, quick investigation and implementation of corrective and preventative actions (CAPA) are paramount to your success. While significant involvement of in-house staff is required to address these issues since they are most familiar with the procedures and practices of your company, the assistance of a neutral party with many years of experience in performing investigations may accelerate the completion of your investigations or offer unique suggestions that may derive a conclusive finding, This can aid prompt resolution and get you back into production sooner. MicroGuard Consulting can review your investigations or assist in their preparation. We can make appropriate CAPA recommendations, and evaluate suitability of those actions.
Microbial Control in Manufacturing
All of the testing in the world does not make a product safe, it only confirms if the product meets the applicable release or stability criteria. Your product safety and efficacy depends on the suitability of the manufacturing process, environment and raw materials, and performance of operators. Microbial control depends on the quality of the materials, processes, personnel and practices to avoid the introduction of harmful organisms, or the removal of microorganisms before, during or after production. MicroGuard Consulting can focus on a single element of your control program, or evaluate the overall microbial control practices of your Company.
Microbiology Training & Presentations
A relevant training program and documented training are regulatory requirements. Yet many companies have only marginal training and poor documentation. This puts your company at risk of not only failure to properly execute procedures and practices, but of significant regulatory action. MicroGuard Consulting can evaluate your microbiology training materials, write training modules, enhance your microbiology training and related topics and if needed conduct training exercises for your company. This will help to satisfy both your initial training requirements and the need for ongoing staff development and continued education. Training can be conducted on site, or via a webinar to accommodate multiple sites. See Presentations for examples of relevant topics or suggest others at Contact Us.
GMP Regulatory Actions
While no one wants to see 483 observations, a warning letter or consent decree, like warning lights on your car’s console these regulatory actions alert you to the fact that your practices need attention. Your company exists to enhance the health of your clients, and in doing so to provide a meaningful return on investment. This is the reason for all of your procedures and practices. The regulations simply offer a minimum guide to achieve your Company’s goals while meeting Federal requirements. Understandably, regulatory actions can consume much time to properly address. If the observations include lapses in practices related to your microbial control strategy and laboratory practices MicroGuard Consulting can assist in responding to the observations, and remediation of the concerns.