Are You 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 is anticipated that both the FDA and MHRA will 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 has 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 Director has 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.
Implementing quality systems, which comply with current regulatory requirements and cGxP, is an area of ZES expertise. ZES can provide support with the following areas of potential inspection observations, which have been a focus in recent 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.
