Environmental Verification allows the company to quantify in an objective manner, the risk of substances transfer from one area to other. It also measures the effectiveness of the existing cross-contamination preventive measures.
Different techniques and organizational measures will be verified, such as pressure cascade, SAS effectiveness, staff training, dress code, etc.
Environmental verification is a vital complement to the risk analysis, established by EMEA and on chapters 3 and 5 of GMPs Mars 2015.
Considering UNE regulations, Qualipharma develops an environmental verification plan break down in the following 3 phases:
1. Development and verification of the measuring plan
Drawing up a protocol allow us to define the project scope, strategy and methodology, and to establish the range and set parameter limits such as the Work Exposure Limit(WEL) for APIs.
2. Plan implementation
Carry out the measuring tests in the facilities with the proper equipment. APIs measuring test in the laboratory station.
3. Conclusions and results report
Verification of the obtained data. If a correct measurement result, a favorable report is issued. If a leak of transference of APIs between production zones is detected, we must find out the possible root causes and apply corrective measures.
Data obtained has twofold relevant uses to both, the quality department (risk assessment) and the prevention department (safe working zones).
- Scientific and evidence-based approach
- Twofold role: QA and PRL