GMP & Manufacturing License
GMP-compliant quality management is the foundation of every pharmaceutical manufacturing site. Good Manufacturing Practice requirements apply to suppliers as well as manufacturers. They define the specifications for careful and quality-assured pharmaceutical production.
Similarly, ISO 13485 defines the normative framework for quality management in the development and manufacturing of medical devices.
Development of QM system
A GMP certificate certifies the quality of GMP-compliant manufacturing processes and is issued for the first time for a new site with a manufacturing authorization in accordance with § 13 of the german AMG. The GMP certificate is then renewed through inspections by the local authorities, usually every 3 years.
But the GMP certificate says nothing about the efficiency with which the GMP guidelines are implemented. We work with you to create a quality management system that is lean, practice-oriented and reliably meets the requirements of the GMP regulations. We are happy to provide you with our templates for pragmatic Standard Operating Procedures (SOPs), which we have created especially for small and medium-sized companies.
Manufacturing authorization
Do you need a manufacturing authorization for a new or the expansion of your existing manufacturing facility? In addition to the requirements for the premises and the QM system, the granting of a manufacturing authorization for medicinal products in accordance with § 13 AMG also requires personnel requirements in the form of a production manager, quality control manager and qualified person must be met.
We are happy to take responsibility for the establishment of an efficient and pragmatic QM system based on our SOP templates and, together with you, for the creation of your process SOPs.
We also regularly take responsibility for communication with local authorities. We are often personally known to your authority representatives.
If your company does not have its own Qualified Person according to § 15 AMG, we will take on this responsibility on your behalf so that you can obtain the manufacturing authorization according to § 13 AMG as quickly as possible.
Authority inspections
We prepare you for inspections by the authorities and support you after the issue of a deficiency letter: As independent consultants, we examine the processes in your quality management system as part of a gap analysis, highlight any serious or critical deficiencies that may have arisen and draw up an action plan for how you can implement the regulatory requirements in your existing QM system in a way that is compliant, reliable and economically viable. We also help you respond to deficiency letters from the authorities, analyze the causes with your team and implement sustainable and reliable preventive measures (CAPA) in your quality management system.
We are also happy to take over communication with representatives of the authorities in the event of conflicts with the authorities, e.g. non-granting of a manufacturing authorization in accordance with § 13 AMG or critical deficiency letters following inspections by the authorities.
We support you with our expertise and experience in production.
Qualification and validation
We provide support in the qualification of equipment and production facilities as well as in the validation of GMP processes and computerized systems (cGAMP).
Troubleshooting
As pharmaceutical technologists with extensive production experience, we solve technical production challenges professionally and efficiently.
Interim management
If managing positions are temporarily vacant in your company, we take on responsibility – for example as interim managers or qualified persons. We are also happy to mentor junior managers.