- No annual review of Environmental Monitoring data and assessment of the continued appropriateness of current action and alert limits.
- Environmental monitoring programs which do not establish investigations or actions for a number of alert limit excursions which occur during a discrete time period.
- Supplier qualification processes which are based criticality of supplier on annual procurement $ spend rather than GxP criticality dimensions such as safety, quality, identity, purity or potency.
- Supplier qualification processes which allow too long a time period between initial qualification audits and subsequent re-qualification audits.
- Supplier qualification processes which do not take into account supplier performance history and the need for adjustments to defined audit frequencies.
- Process qualification of critical quality attribute ranges which are not scientifically justified based upon DOE or other science based rationale.
- Computer systems validation of key systems used to support quality or production systems which does not include a periodic review process following initial validation to evaluate the collective impact of change controls and the maintenance of the validated state of control.
- Recall procedures which do not include provisions for a mock recall to verify lot genealogy/traceability.
- IT back-up processes which utilize automated tools/utilities with no manual review of backup logs to verify that there were no failures or files skipped. No process for investigation or escalation of backup failures to IT management.
- Failure of cleaning validation to consider limit of detection, limit of quantification, various materials of construction and risk parameters such as worst-case model compound, solubility, number of difficult to clean areas and total product contact area.
About the Author:
Robert (Bob) Lesnefsky is the Global Vice President of Quality Assurance and Regulatory Compliance and Auditing at USDM Life Sciences. He is a seasoned quality assurance and regulatory compliance professional with 30+ years of experience in quality assurance and regulatory compliance in the pharmaceutical, biotechnology, medical device, nuclear and petrochemical industries. Bob is sought out as the GMP/DEA compliance expert in providing compliance opinions and interpretations of cGMP to manufacturing, operations, quality and client services to ensure compliant drug product manufacturing operations.
USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.