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.
If your particular situation requires investigation and determination of corrective action and prevention (CAPA), why not go to the group of independent, successful consultants who can address you needs in an effective and practical manner? Investigation and root cause analysis for issues of biological contramination is a technically demanding area. Let Microbiology Network help.
Consultants from the Microbiology Network are drawn from national experts with experience in the Pharmaceutical, Biotech, OTC and personal care products industries. No matter the specifics of your situation, we have someone who can help.
FDA concerns over GMP in compounding pharmacies has resulted in a large number of 483s issued in this area – the most common citation being that procedures to prevent microbial contamination of medicines are not existent or not followed. Let Microbiology Network consultants guide your compounding pharmacy to effective microbial contamination control.
Numerous court cases have been centered on product contamination leading to sickness or death. Microbiology Network consultants can serve as expert witness support in case preparation or testimony.
Historically, diverse markets such as pharmaceuticals, compounding pharmacies, medical devices, diagnostics and personal care products have operated under very different CGMP. However, the considerations for contamination control are similar and can be approached from the perspective of root cause analysis. This type of “Cause and Effect” diagram can be an excellent learning tool for the contamination control team as well as leading to valuable insights in the determination of likely routes of contamination after the fact, but can also be used as a proactive learning tool for the development of the Contamination Control Plan
The Microbiology Network can assist in all aspects of contamination control. Our network of internationally-recognized experts will assist in developing your Contamination Control Plan as a proactive step to prevent issues, or as part of remedial activities to correct a situation recently brought to light.
Contact Microbiology Network to see how we can help.