New GMP Document In Response To COVID-19
Zener Engineering Services Ltd • 18 December 2020
World Health Organization
In response to the recent urgent need for the fast development of health products in the treatment of COVID-19, the World Health Organization (WHO) are in the process of developing a Good Manufacturing Practice (GMP) document to address the manufacturing of developmental batches, pilot batches and the sequential stability data that is submitted in product applications (dossiers) for marketing authorization and the prequalification of medical products.
There are currently no regulatory guidelines which address this matter, although the data collected from these batches influences the following aspects of the product:
- Stability
- Process validation
- Analytical method development and validation
ZES clients in the Research and Development (R&D) sector will benefit from this document.
Once approved ZES will be able to help its clients achieve the required GMP standard to safeguard the R&D company and its patients.
How have ZES Supported Research and Development Companies Recently?
ZES continue to help R&Ds along their product development journey and have a strong track record of working in the sector. ZES work to solve problems and accelerate successful GMP outcomes that generate health for our clients' patients. These activities include, but are not limited to:
- Process Scale up.
- Gap Analysis and Risk Assessments highlighting areas for improvement.
- Lease agreement review.
- Mentor in GMP engineering culture approaches and practice.
- Review maintenance approaches, including critical calibration tolerances.
- Mentor in GMP Validation, including CSV.
- Development of documentation to GMP standards.
- Mentor in technical engineering issues.
- New facility design reviews from a technical GMP-level perspective.
- Project management.
- Manage suppliers and activity reviews.
- Look after the GMP Quality engineering interests of the client R&D company.
Quality and Reliability
ZES provide a first-class comprehensive engineering service, covering a wide range of Pharmaceutical, Medical Device manufacturing operations and Healthcare provider services.
We provide a specialist engineering service for projects, maintenance and consultancy enabling engineering tasks (large or small) to be outsourced to a single point of contact.
GMP Quality and Reliability are at the centre of everything ZES do.
Speed and Flexibility
ZES provide speed and flexibility whilst responding to the changing needs of our clients, from small single drawings to project management of large capital projects.
The ZES business model allows us to operate all over the UK, whilst being able to promptly deliver a first-class quality engineering service.
All aspects of pharmaceutical and medical device manufacturing are covered, to the highest of standards.
FDA / MHRA Experience
ZES personnel have worked with former FDA inspectors and have fronted FDA and MHRA inspections.
ZES have worked to ensure a successful inspection outcome.
Inspection preparation and remediation are areas of significant experience for ZES.
Value for Money
ZES deliver by utilising hands-on approaches, drawing on the professional experience of our consultants to provide our customers with a flexible and value-for-money partner.
All ZES clients have access to our management team at no extra cost.
Through careful use of ZES resources, we can deliver the same level of service as provided by much larger companies, more quickly whilst delivering a better service. Our business model allows ZES to pass on savings.
- Expert Advice by Utilising Proven Experts
- Consistently High Standards and Service Levels
- Transition and Education for Client Staff
- Dedication and Passion from Industry Experts
- Speed and Quality of Service and Delivery. (Small or Large Projects)
- Assurance to Executives of our Credentials and Practices
- Leaders' Assistance in Assessing and Managing Risks
- Consultants with Integration Expertise
- A Fresh Perspective
- Best Practice Recommendations
Just GxP Engineers
ZES only utilise GxP engineers who hold relevant qualifications and possess hands-on experience in engineering or science. Our clients also enjoy complimentary access to the ZES senior management team, on an ad-hoc basis, during the engagement. All ZES engineers have proven GxP experience.
ZES do not utilise dedicated sales persons, recruitment agencies or other non-engineering bodies.
ZES utilise a network of over
150 experienced GMP engineers.
GxP Engineers Providing Services Direct
Whatever your requirement, ZES can provide a professional compliant engineering service, that is streamlined and suitable for its purpose, whilst accommodating your business needs.
Come directly to the GxP Engineering Experts!
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