Blog Post
MHRA FDA or EMA Inspection Ready In 2021?
- by Zener Engineering Services Ltd
- •
- 17 Feb, 2021
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Are You Trained For The Inspection?
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 2021 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.
The 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.
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.
The 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.
For more information on regulatory inspections click
here.
How ZES Have Helped Clients
Implementing quality systems, which comply with current regulatory requirements and cGxP, is an area of ZES expertise. ZES can help with the following areas of potential Inspection observations, which have been a focus in recent inspections:
- Quality Systems
- Sterility Assurance
- Production Systems
- Qualification / Validation
- Premises and Equipment
- Computerised Systems
- Data Integrity
- GMP Experienced Personnel
- Documentation
- Quality Control
- Good Engineering Practice
- Inspection Preparation and Training
- Back Room Operations
- Supplier Documentation Reviews
- Maintenance Strategy Reviews
ZES Inspection Readiness Training
The experienced ZES FDA / MHRA Inspection trainer will deliver a valuable training course covering subject matters such as the following:
- Logistics
- Inspector Facts
- Inspection Preparation
- SME Training
- Common Pitfalls
- Question Styles
- Dos and Don'ts
- Practice Scenarios
- Case Studies
- Back Room Operations
Contact ZES with all your Inspection concerns
Let ZES take the stress out of your Inspection
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