Kastango Consulting Group – Environmental Monitoring Services

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Environmental Monitoring Sampling Plan Review with Consultation

Our consultants will review a client-provided environmental monitoring (EM) sample location diagram to assess the existing sample locations and provide recommendations to sample locations. The assessment and recommendations will be based on risk to the compounded sterile preparation through the identified workflow description provided by the client, USP 797 requirements, and CriticalPoint best practices.

Sampling Plan and Program Review

Our consultants will conduct a review of client-provided environmental monitoring (EM) sample location diagram to assess the existing sample locations. The assessment and recommendations will be based on risk to the CSP through the identified workflow description provided by the client, USP 797 requirements, and CriticalPoint best practices.

Review environmental monitoring program through an analysis of the following:

• facility sampling standard operating procedures (SOP(s))
• vendor sampling SOP(s) (if applicable)
• the most recent laboratory analysis report
• data collected over the last year
• data trending program review
• environmental excursion SOP/documentation

Sampling Plan and Program Review with Onsite Risk Assessment

A consultant will conduct a one-day onsite visit to determine environmental monitoring sample locations through a risk assessment based on the facility layout, workflow, personnel observations, and CriticalPoint best practices. Before the onsite visit, program elements as described below will be assessed through a review of the documentation and data provided by the client.

Review environmental monitoring program through an analysis of the following:

• facility sampling standard operating procedures (SOP(s))
• vendor sampling SOP(s) (if applicable)
• the most recent laboratory analysis report
• data collected over the last year
• data trending program review
• environmental excursion SOP/documentation

Third-Party Laboratory/Vendor Quality Audit

A consultant will conduct a one-day remote or onsite audit of the laboratory or certification vendor providing the environmental monitoring services. The audit will access the critical components related to the environmental monitoring program, the laboratory facility, sample analysis, and related quality systems.

Environmental Excursion Investigation and Remediation

A consultant will conduct a full-day facility assessment to evaluate the current environmental state of control relative to USP Chapter <797>. The consultant’s strategy will be to assess the physical plant, cleaning and garbing activities, work practices, standard operating procedures (SOPs,) and environmental monitoring (EM)-related data. If it can be arranged the consultant will also assess EM sampling procedures, including testing collection methods and sample transport.

Environmental Monitoring Report Evaluation

Kastango Consulting Group will provide a comprehensive review of the client’s most recent air and surface sampling reports evaluating report content, accuracy, and reporting methods against industry-accepted standards.