GxP

The term GxP is used to indicate multiple quality systems, intended for several types of organizations. GMP is the guideline for the manufacturing/testing and release of medicinal products. GDP is the guideline that applies to the wholesale and distribution of medicinal products. GLP is the guideline for (animal) laboratories involved in all types of laboratory studies. Progress has expertise in the field of GxP quality systems, which we have listed below:

GMP – Good Manufacturing Practice

Guidelines for Good Manufacturing Practice of medicinal products for human and veterinary use have been laid down by the EU respectively in EudraLex Volume 4 Good Manufacturing Practice guidelines. In addition, guidance notes, Q&A papers and interpretation documents have been developed, for example by the ICH, the ISPE, the PICs and the PDA committees.

 

Building on 25 years of experience in the pharmaceutical sector, Progress has a strong background in all aspects of Good Manufacturing Practice for medicinal products and APIs. We know the rules, keep ourselves informed and we know how to apply them. We employ people from many diverse backgrounds and share our expertise with each other. That is why you can always receive multidisciplinary input from one of our consultants.

Progress can help you optimize your manufacturing processes according to current GMP standards
Pharmaceutical technician in sterile environment working on production of pills at pharmacy factory

GDP – Good Distribution Practice

In recent years, it has been a focus for inspectors and manufacturers to control the wholesale and distribution of medicinal products. It is recognized as an important activity in supply chain management: the responsibility of the manufacturer and the wholesaler does not stop at the door.

In 2013, Good Distribution Practice was implemented in the new European Commission Guidelines on Good Distribution Practice of medicinal products for human use, which sets out the requirements for a wholesaler of medicines. Progress has experience with all aspects of these guidelines, and we can support your organization with the implementation or improvement of your quality systems, your audit program or training. We also offer (interim) Responsible Person services.

GLP – Good Laboratory Practice

The Good Laboratory Practice guidelines are intended to ensure the quality and validity of data and to promote mutual acceptance of data between laboratories. Developed in agreement with the Organization for Economic Co-operation 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: Guidelines for the Testing of Chemicals and Good Laboratory Practice standards. Regulatory bodies certify laboratories according to GLP.

Progress can support your laboratory during this certification process. We can also help you improve or update your GLP quality systems.

Progress offers various services: Consultancy, Project Management, Interim Management and Temporary Staffing.

We collaborate closely with our clients to ensure data quality and validity, and improve GLP quality systems
We collaborate closely with our clients to ensure data quality and validity, and improve GLP quality systems

We collaborate closely with our clients to ensure data quality and validity, and improve GLP quality systems

GAMP – Good Automated Manufacturing Practice

The GAMP guidelines, created by the ISPE (GAMP Good Practice Guides | ISPE | International Society for Pharmaceutical Engineering), have become the international standard for the life cycle management of electronic systems. The GAMP provides guidelines for the implementation, validation, and maintenance of all types of electronic systems. With electronic systems even more than with other systems, a clear focus on the required functionality and on risk assessment as a basis for validation and maintenance is key for a successful implementation process. Progress offers consultancy on all aspects of life cycle management. We can provide experienced project managers as well as validation engineers and QA oversight.

Records and data life-cycle model from the ISPE GAMP Guide: Records and Data Integrity
Records and data life-cycle model from the ISPE GAMP Guide: Records and Data Integrity