Good x Practice (GxP) inspections are critical to ensuring that life science companies comply with industry benchmarks for safety, data quality and product efficacy. Cleanrooms are often the focus of these types of reviews due to their role in ensuring patient safety. They need to prove that they are consistently cleaned and sterilised to reduce the risk of harmful bacteria and viruses.
This level of cleanliness is outlined in numerous global regulations, including those of the Medicines and Healthcare products Regulatory Agency (MHRA) and the Food and Drug Administration (FDA). Regulations require manufacturers to demonstrate and certify that they are conducting environmental monitoring and providing risk-based contamination control strategies.
To continue operations, it is essential that the cleanrooms pass inspection, thereby ensuring they meet regulatory requirements. It is essential to understand what to expect during a GxP inspection, including the observation of operational documentation, real-time cleanroom performance, environmental monitoring (EM) data, and trace material and personnel flows. Procedures and evaluated practices must align to avoid failing the inspection.
Additionally, there are ten areas that pharmaceutical companies should keep in mind, ranging from conducting a risk assessment to verifying materials and workflows, which will help them pass their FDA, MHRA and EU Annex 1 inspections, including:
Tip 1: Self-review and risk assessment
Teams can prepare for their GxP inspection by conducting a mock regulatory audit. They should conduct a full cleanroom walk-through, ask operators to explain their aseptic behaviours, and verify that flows and practices align with SOPs. The walk-through should include key test areas, including HVAC performance, Contamination Control Strategy (CCS) implementation, EM data integrity and cleaning routines.
Tools like ICH Q9 can aid in this preparation by identifying vulnerabilities that need to be fixed before the real inspection. Additionally, account for the different regulations depending on where they operate. For the FDA and MHRA, teams should be ready to proactively identify contamination risks and common GMP deficiencies.
Tip 2: Data integrity and security
Data Integrity is imperative, regardless of what a company is or what industry it operates in. Cleanroom monitoring generates records, including viable and non-viable particle counts, equipment qualification data, environmental monitoring (EM) results, and pressure differentials.
Regulators will review records for compliance both digitally and on paper to ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
Plan to provide trend reports and raw data during the inspection. Additionally, teams should ensure that computer access is restricted by role and that critical systems are audited, as this is imperative for data security. All team members must be trained and able to effectively explain data for a successful audit.
Tip 3: CCS and environmental monitoring programme
While not mandated by the FDA, it is essential to have a robust CSS, as the EU Annex 1 requires it. This Annex includes viable and non-viable monitoring of ≥5.0 µm particles during routine operations for Grades A-D. CCS should be maintained so they are current in conjunction with EM and septic controls. Note that the FDA will focus on the EM and aseptic controls only for control particles ≥ 0.5 µm.
Tip 4:
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