Maintaining a GMP compliant facility requires fastidious attention and due diligence. In addition to assuring that the product(s) you generate are meeting the standards you demand, as well as regulatory requirements, you must make certain that the manufacturing and storage areas at your facility do not harbor an environment capable of contaminating the products you have worked so hard to produce.
Designing and executing a well thought out and effective environmental monitoring (EM) program can provide peace of mind, allowing more time to perfect your product(s) and processes. Finding the right partner to help execute this EM program is vital to streamlining your system, keeping costs down and allowing employees to focus on their intended roles.
Q Laboratories can provide a number of testing services to help you achieve the goals of your EM program and assist you in meeting full GMP compliance.
- Enumeration of Bacteria and Fungi from Air Settling Plates- USP <1116> Processing Environments
- Enumeration of Bacteria and Fungi from Air Settling Plates- USP <797> Pharmaceutical Compounding Environments
- Enumeration of Bacteria and Fungi from Surface Contact Plates- USP <1116>
- Total Aerobic Microbial Count from Swabs- USP <61>
- Total Yeast and Mold Count from Swabs- USP <61>
Water can be a significant part of production, cleaning and sanitization. Performing tests described in USP <1231> – Water for Pharmaceutical Purposes, will prove to be a valuable part of your environmental monitoring.
- Heterotrophic Plate Count –Pour Plate <1231>
- Heterotrophic Plate Count– Membrane Filtration <1231>
- Total Coliform- Standard Methods for the Examination of Water and Wastewater, 22nd Ed.
- Bacterial Endotoxin Test <85>
- Water Conductivity <645>
- Total Organic Carbon <643>