As a chemical engineering office, we have focused our focus on pharmaceutical quality assurance and manufacturing. We are happy to support you in various issues not only around pharmaceutical quality management but also around the topics of process optimization, audit preparation or supplier qualification.
Data integrity is increasingly becoming the focus of authorities and, as apis labor GmbH, we have acquired extensive expertise in the areas of computer validation and project management for systems such as ERP, MES or LIMS.
If you need our support on site, we can also help you with complex questions. We would be happy to advise you in the areas of quality assurance and quality control. You can benefit from our many years of experience in pharmaceutical companies. Our experts cover the entire pharmaceutical spectrum and have experience in a wide variety of official requirements (EMA, FDA, AGES, ANVISA, etc.).
CSV - Software Validation.
Computer System Validation (CSV) / Software Validation. Computer-aided systems today play a central role in the development and manufacture of pharmaceuticals and medical devices. Authorities and notified bodies are increasingly making the subject of CSV the subject of audits. We are happy to help you from the concept phase to the implementation of projects.
analytical Project management
There is no definition in the form of an official guideline for the transfer of analytical methods. In the context of the transfer, parameters such as devices and equipment, methods, acceptance criteria of the laboratories involved are defined indirectly. This makes the topic quite extensive and can lead to significant delays in product calibrations.
QM Management
What Good Manufacturing Practice (GMP) means for the pharmaceutical industry, HACCP means for the food or dietary supplement industry. A functioning quality management system is the guarantee for high-quality products. Stay on the ball with apis labor GmbH when it comes to deviations, change notifications or work instructions. We would be happy to support you in setting up and maintaining your QM system.
Auditing
Have you found your perfect supplier, but no resources to qualify them through an audit? We are happy to take care of this for you! The know-how in the implementation of supplier qualifications ranges from the packaging material to the active ingredient manufacturer. We are also happy to support you in conducting customer and authority audits, as well as in self-inspections.
GMP Shooling
Qualified employees are your key to success! And it is important to stay on the ball and continuously develop the company's own GMP processes. Since June 2011, eight of the nine chapters of the EU GMP guidelines have been completely revised, only the chapter on self-inspections has remained unchanged. There are also a number of other new European regulations.
Consultant activities
If you need our support on site, we can also help you with complex questions. We would be happy to advise you in the areas of quality assurance and quality control. You can benefit from our many years of experience in pharmaceutical companies. Our experts cover the entire pharmaceutical spectrum and have experience in a wide variety of official requirements (EMA, FDA, AGES, ANVISA, etc.).
