SOP Drafting or Review and Revision
Writing SOPs can be a huge undertaking. Or maybe you just want an expert review of you existing SOPs and some guidance improving processes and procedures. Pure Microbiology can help with drafting and revision of SOPs.
Quality System Implementation
Each organization’s quality system is unique and starting one from scratch can be overwhelming. By partnering with Pure Microbiology we will work together to put a system in place that is both comprehensive and functional for your business’s needs.
Microbiology Laboratory Audit
Not sure if your microbiology lab is able to meet your needs? Let our consultant help. They will conduct a one-day remote or onsite audit of the contract microbiology lab providing analysis viable air and surface sampling, sterility testing, endotoxin testing, and other product testing. The audit will access the lab’s facility layout, sample analysis, training program, and the quality management system. An audit report will be generated with observations, which the client can submit to their lab. The consultant will also assist the client in the follow up of any observations.
Laboratory Gap Analysis
Are you looking to offer USP <797> microbiology testing services at your lab? The consultant will assess your current incubation and testing capabilities and make suggestions on how you can best serve USP <797> customers.
Abby Roth has been an invaluable resource for our organization’s sterile compounding program. Abby’s extensive knowledge of USP <797> regulations, best practice compounding skills, and environmental monitoring practices has guided our organization successfully for many years. Abby’s support has been instrumental in helping to develop and implement improved policies to promote rigorous oversight in our sterile compounding program. Abby is extremely efficient with great attention to detail when reviewing certification reports or viable environmental results. I would recommend Abby Roth and Pure Microbiology to anyone in the sterile compounding field who wants a successful and compliant program.
My management staff and I have had the pleasure of working with Abby for ISO17025 audit / accreditation support. Additionally, she has consulted with us on various projects within the Quality and Microbiology world, and has been an excellent outside resource to our organization.
Abby has been my go-to microbial expert. Her knowledge of microbial contamination, EM reports, and sterile facilities, is one of the best in the Industry. She has helped me through the years and I have learned so much about sampling and contamination control from her. Whenever I or a customer have a question, she is always receptive and educational.