Achieve seamless fulfilment of GMP compliance
Good Manufacturing Practice is a core condition in pharmaceutical manufacturing worldwide, but not an easy task. Rules and interpretations differ from country to country, and they change frequently. If quality considerations are not integrated in to your projects early enough, delays and quality issues are also certain to arise. Quality documentation and validation on the other hand demand a lot of resources.
With our certified and pharmaceutically trained professionals, NNE Pharmaplan offers you seamless fulfilment of GMP. We have the expertise and international experience to handle the ever-more complex quality demands through GMP compliant design and solutions, the quality documentation and validation in projects.
ENSURING INSPECTION READINESS
With our extensive knowledge of cGMP guidelines, drug regulations from FDA, ICH, WHO, PIC, EU and all relevant industry standards we help you succeed with all audits carried out by agencies, accredited bodies or customers. We provide services to many customers to ensure ongoing regulatory compliance – for example mock-up inspections, gap analysis, audits of suppliers or training and implementation assistance. We have assisted several customers in solving inspection issues from FDA 483s or warning letters, and have a vast experience in the science and risk based approach to quality issues, process validation and many other issues.
QUALITY BY DESIGN
Pharmaceutical manufacturing and development is entering a new paradigm. When applied correctly, it can be highly effective and increase flexibility, product quality and overall efficiency. It is part of the regulatory harmonisation between the USA, Europe, Japan and other countries.
NNE Pharmaplan has been involved in the preparation and implementation of QbD concepts and related practices for several years. We have carried out training, consulting and implementation for customers to ensure cost-effective solutions and compliance with future regulatory requirements.
FDA’S NEW PROCESS VALIDATION
The requirements for process validation are changing. FDA issued a new guideline in 2011 and the European GMP regulation for process validation is currently changing. There are many similarities between the new principles, and NNE Pharmaplan has been part of the training and implementation of these principles for several years. New concepts for commissioning, qualification, FAT, SAT and the verification standard ASTM E2500 enable a cost-effective alternative to the conventional DQ/IQ/OQ/PQ approach. This can save you both money and time while improving quality and increasing patient safety. Our experts have helped several customers transform their traditional qualification and validation approaches to the new guidelines.
Pharmaceutical manufacturing is not possible without technology transfer, but it is still a challenge. Some manufacturing companies have limited resources for tech transfer. That is why NNE Pharmaplan can provide you with an international, interdisciplinary team, who can cover everything from GMP compliance and regulatory demands to startup of production, qualification of transferred process and project management.
WHY PARTNER WITH NNE PHARMAPLAN?
- We are born out of GMP and have 25 years of experience in the field.
- GMP is an integral part of the work our trained engineers deliver.
- We integrate with your existing quality systems.
- We apply customer-audited quality systems that support your GMP.