Risk analysis in elaboration of environmental monitoring programs

The purpose of the environmental monitoring program is to prove acceptability of the required drug manufacture conditions, to control concentration of contaminating agents (microorganisms and particulate matter) in the manufacturing environment, to be able to detect deviations and possible sources of contamination, as well as to elaborate relevant corrective and preventive actions. The monitoring program shall guarantee immediate feedback allowing for urgent elimination of any problem detected throughout the whole process of manufacture of each product batch/lot.

In terms of manufacture of sterile drugs, GMP guidelines establish rather stringent requirements for organization and implementation of environmental monitoring. Non-conformities related to improper execution of environmental monitoring activities are expected to be classified as major or critical as they undermine sterility/microbial purity of products and, consequently, may have a negative impact on drug  safety when administered by a patient.

Taking into account risk management principles integrated into the GMP philosophy, environmental monitoring shall be considered as one of the key objects of risk management embracing the peculiarities of products manufactured, the technology of their manufacture and the equipment used in it. To properly implement risk management principles in terms of environmental monitoring in practice, it is necessary to form respective competences with personnel responsible for this process, including a pool of theoretical knowledge and practical skills in the domain.

• an overview of regulatory requirements for environmental monitoring in connection with risk analysis in pharmaceutical manufacture;
• recommendations on the application of risk analysis methods and tools when elaborating monitoring programs;
• a presentation of the key information in terms of the equipment and materials used in environmental monitoring, as well as planning and reporting about the process;
• a discussion and a detailed analysis of the most frequent non-conformities found during inspections on the environmental monitoring topic;
• an overview of current expectations of the inspectorate in terms of risk analysis application in elaboration of environmental monitoring programs according to EAEU GMP and Russian GMP.