USDM subject matter experts share the Top 10 observations they see when conducting audits in the United States and abroad.
No matter what the audit platform, there are significant reoccurring themes that continue to plague life sciences companies.
- There is no annual review of environmental monitoring data, nor is there an assessment of the appropriateness of the actions and alert limits that are in place.
- Environmental monitoring programs do not have established investigations or actions for alert limit excursions that occur during a discrete time period.
- Supplier qualification processes are based on annual procurement cost rather than GxP requirements for safety, quality, identity, purity, or potency.
- Supplier qualification processes that allow too long a time period between initial qualification audits and subsequent re-qualification audits.
- Supplier qualification processes that do not take into account supplier performance history and the adjustments to audit frequency.
- Process qualification of critical quality attribute ranges that are not justified based upon design of experiments (DOE) or other science-based rationale.
- Computer system validation to support quality or production systems does not include a periodic review process to evaluate the collective impact of change controls and validated state of control maintenance.
- Recall procedures that do not provision for a mock recall to verify lot genealogy/traceability.
- IT back-up processes that use automated tools and utilities do not include a manual review of backup logs to verify that there were no failures or skipped files. Also, there is no process to investigate or escalate these failures to IT managers.
- Cleaning validation processes do not consider limit of detection, limit of quantification, various materials of construction, and risk parameters (for example, worst-case model compound, solubility, number of difficult-to-clean areas, and total product contact area).
Why Trust USDM?
USDM Life Sciences has a combination of over 100 years in regulatory compliance, quality assurance, quality systems, and auditing. USDM’s Global Audits Practice Team perform audits for pharmaceutical, biotech, and medical device companies in the United States and abroad.
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