Face-to-Face MHRA / FDA Inspection Ready?
In 2018, the FDA issued over 30 warning letters in Europe alone, with a large proportion going to Manufacturers who did not apply appropriate controls and oversight to their contracted-out operations. Also, a significant proportion of the warning letters cited Data Governance and Data Integrity as not meeting the required standard to satisfy the associated regulatory requirements. It was anticipated that both the FDA and MHRA would continue to focus on these areas in 2019 and beyond.
Why wait for the regulators to impose delays to product approvals or force the suspension of manufacturing activities to implement any necessary Facility, Utility, Computer System and Equipment remediation? ZES have worked closely with former and current inspectors to ensure GxP Facilities, IT Infrastructure, Process Equipment and Computer Systems reach the required standard for their first inspection and inspections beyond.
ZES personnel have sat in front of the FDA and MHRA during an inspection, to help facilitate a successful inspection outcome. If you need help with inspection preparation, implementing quality systems or validation, ZES have experienced GMP engineers ready to support you with your GMP requirements.
Face-to-Face Inspections to Restart
With the easing of restrictions in the UK and U.S., the MHRA and FDA are free to tackle their pandemic-induced backlog of site inspections in person.
Pharmaceutical firms need to prepare for on-site inspections, as it's expected that regulatory inspectors will adopt a risk-based approach to prioritise face-to-face inspections, whilst maybe conducting parts of the inspection process remotely in the short term.
Regulatory Authorities may determine which aspects of an inspection can be performed remotely, maybe through electronic access to documentation in advance of the face-to-face inspection. Face-to-face meetings during the inspection may be minimized, with the potential of video conferencing including on-site personnel in a different location.
How can ZES Help Before, During and After the Inspection?
ZES can provide support with the following areas of potential inspection observations, which were a focus in pre-pandemic inspections:
- Quality Systems
- Sterility Assurance
- Production Systems
- Complaints and Recall
- Qualification / Validation
- Premises and Equipment
- Computerised Systems
- Data Integrity
- Personnel
- Documentation
- Quality Control
- Good Engineering Practice
- Inspection Preparation and Training
FDA inspection or MHRA inspection concerns? Supported by ZES, GxP clients achieve successful outcomes.
ZES have worked with former FDA inspectors.
