GMP Consulting - agil and reliable
By GMP consulting, I provide on-site advice or take on specific tasks and roles that cannot currently be covered by your staff. My expertise covers a profound knowledge of quality management, various aspects of microbiology in the pharmaceutical industry, and especially validation of computerized systems.
1. Do you have a problem for which you lack the internal know-how?
Outsourcing does not only serve the purpose of increasing resource capacity. It can also provide access to qualified, skilled and experienced personnel at the time when they are needed most. Namely, when issues need to be resolved immediately and there is no time to train internal teams. Let me help you out quickly and easily by bringing in a Pharma Consultant. Call or write an email.
2. Do you have an urgent project for which you have no resources?
Many of your permanent employees are probably already fully occupied with their daily business. If an additional project is added, for example to increase efficiency or optimize existing processes, it may be that none of your employees has enough free capacity to work in that additional project. As a freelancer, I can step in at any time and drive the project forward for you.
3. Do you need qualified support at short notice?
Nowadays, flexibility and agility are terms that no modern company can do without. But this is not always easy to implement. In order to be flexible and agile, additional qualified personnel may be needed at short notice, which cannot be hired today and dismissed tomorrow. Dephamon GmbH can be the solution.
Maybe one of your employees would like to take a longer unpaid leave, or a longer maternity or paternity leave? As a temporary contractor I can help you out and bridge this time.
That’s why working with me is advantageous:
- GMP specialist with over 10 years of GMP compliance experience
- Successful in the GMP market for several years
- Reliable and always up to date with the latest GMP standards
- Individual and solution-oriented consulting
GMP Consulting for Quality Management
The quality management system covers all aspects that can influence the quality of a product. A well structured and organized quality management system therefore forms the basis for compliant manufacturing. Quality management in accordance with the Eudralex Vol.4 chapter includes quality assurance measures such as training of employees, self-inspections as well as a systematic process for identifying and assessing risks.
Other sub-areas of quality management are deviation management and change management. Changes to a standardized process must be documented in detail and be traceable at all times. In addition, planned changes are evaluated in advance for their risk to product quality. When dealing with deviations, risk management is essential in order to assess the impact of the deviation on product quality and define appropriate measures.
GMP Consulting for Microbiology in the pharmaceutical industry
Microbiology is an important factor in the manufacture of pharmaceutical products, relevant to patient safety, among other factors. Dephamon has extensive experience in all aspects of microbiological contamination control, from cleanroom gowning, cleanroom hygiene and environmental monitoring to optimal design of aseptic work procedures and analysis of intermediate and final products. I can provide comprehensive support for creating a contamination control strategy, ensuring your manufacturing processes meet the highest standards.
Contact me today to learn more about my services and expertise.
GMP Consulting for Computerized System Validation
(CSV)
Computer systems facilitate tasks in offices as well as in laboratories or production facilities of all kinds. Software systems used in GMP-regulated environments must be validated and meet the requirements of Eudralex Volume 4, Annex 11 Computerised Systems or CFR 21 Part 11. The validation of computerized systems according to the GAMP 5 approach is well established in the industry and contains valuable tips for the practical implementation of the regulatory requirements. Press the following button and you will find useful information on the subject of computerized system validation.
