The term GxP is used to indicate multiple quality systems, intended for different types of organisations. GMP is the guideline for manufacturing / testing and release of medicinal products. GDP is the guideline applicable to the wholesale and distribution of medicinal products. GLP is the guideline for (animal) laboratories involved in all types of laboratory studies. Within Progress-PME expertise is present on GxP quality systems, we have outlined these below:
GMP – Good Manufacturing Practice
Guidelines for the Good Manufacturing Practice of medicinal products for human and veterinary use are laid down by the EU in Commission Directives and of course Volumes 4 and 5 respectively. Additionally, notes for guidance, Q&A papers, and interpretation documents have been developed, for example by the ICH, the ISPE, the PICs and the PDA committees.
Building on 20 years of experience in pharma, Progress-PME has a strong background in all aspects of the Good Manufacturing Practice of medicinal products and API’s. We know the rules, keep ourselves up to date and we know how to apply them. We employ people from many different backgrounds and share our expertise amongst each other. Therefore you always have opportunities to receive multi-disciplinary input from any of our consultants.
GDP – Good Distribution Practice
In the past years, it has been a focus point for inspectors and manufacturers to bring the the wholesale and distribution of medicinal products under control. It has been recognised as an important activity in the supply chain management: the responsibility of the manufacturer and the wholesaler does not stop at the door.
In 2013 the new Commission guideline on Good Distribution Practice was implemented, laying down the requirements for a wholesaler of medicinal products. Progress-PME has experience with all aspects of these guidelines and we can support your company with the implementation or improvement of your quality systems, your audit program, or training. Also we offer (interim) Responsible Person services.
GLP – Good Laboratory Practice
Good Laboratory Practice guidelines intend to ensure the quality and validity of data and promote mutual acceptance of data between laboratories. developed in accordance with the Organisation for Economic Cooperation and Development (OECD), the EU has adopted these principles and the revised OECD Guides for Compliance Monitoring Procedures for GLP as annexes to its two GLP Directives. Regulatory bodies certify labs according to GLP.
Progress-PME can support your laboratory during this certification process. Also we can help you improve or update your GLP quality systems.
GAMP – Good Automated Manufacturing Practice
Created by the ISPE, the GAMP guidelines have become the international standard for the life cycle management of electronic systems. The GAMP provides guidance for the implementation, validation and maintenance of all types of electronic systems. With electronic systems even more than other systems, keeping a clear focus on the required functionality and on risk assessment as the basis for validation and maintenance is key to a successful implementation process. Progress-PME offers consultancy in all aspects life cycle management. We can provide experienced project managers, as well as validation engineers and QA oversight.