Frequently Asked Questions (FAQs)

General Questions about Schmidt GMP-Compliance

  • Schmidt GMP-Compliance is your personal partner for GMP excellence. With over 30 years of international experience, I offer Swiss precision and a 100% focus on your project. Unlike large consulting firms, where projects are often passed around, I personally dedicate myself exclusively to your assignment to deliver optimal, trustworthy results.

  • I provide specialized GMP and GxP compliance consulting for the pharmaceutical industry, medical devices, cosmetics, and logistics (GDP), as well as the cannabis industry (GACP). My expertise is tailored to the specific requirements of each of these regulated sectors.

  • Whenever possible, I offer transparent flat-rate pricing that gives you full cost control and planning security – with no hidden fees or surprises. For complex projects requiring a detailed preliminary discussion, I will be happy to provide you with a custom quote.

  • Yes, my expertise is global. I've conducted audits and projects in various international markets, including USA, Switzerland, Germany, France, India, and Canada. My services are tailored to global standards and requirements.

  • I offer practical GMP training tailored to your team's needs, covering a wide range of critical topics. This includes the "GMP Foundations Express" (a 4-hour session for fundamentals), the "Advanced Compliance Workshop" (a full-day session for in-depth topics), and custom multi-day programs. Key training areas include: Data Integrity, Deviation Management, Hygiene, CAPA, Audit Readiness, and Good Documentation Practice (GDocP).

  • All training sessions can be conducted in either English or German, as per your preference.

  • Online training is more efficient due to the elimination of travel time and costs, as well as reduced logistical effort on my part. I pass these efficiency gains to you in the form of a 10% discount. The quality of my expertise and the content, however, remains consistently high.

  • Simply book your desired training online on my website. You'll immediately receive a booking confirmation via email with the next steps. I'll then personally contact you within 24 hours to coordinate the ideal training date and time that fits your team's schedule, ensuring maximum flexibility and convenience. After the date is mutually agreed upon, you'll receive a final confirmation email with all details.

  • Yes, upon successful completion of each training session, all participants receive a qualified certificate of participation.

Questions about Audits

  • I conduct independent third-party audits for suppliers and contract manufacturing organizations (CMOs), including GMP audits (for pharma and medical devices), GDP audits (for logistics), ISO 13485 audits (for medical devices), ISO 22716 audits (for cosmetics), and GACP audits (for cannabis).

  • My audit services cover the D-A-CH region (Switzerland, Germany, Austria) as well as the rest of Europe, North America, Asia, and South America.

  • My structured audit process includes: initial contact with the auditee, pre-audit review of relevant documents, development of a tailored audit plan, on-site audit execution, creation of a detailed audit report, discussion of findings with you, and submission of the final report to the auditee.

  • No, Schmidt GMP-Compliance cannot guarantee the successful outcome of any audit or regulatory inspection. Any consulting firm that provides such a guarantee acts unprofessionally. My services are designed to maximize your compliance and inspection readiness, minimize risks, and prepare you optimally. The final decision, however, always rests with the auditing party or the competent authority.

Questions about Documentation and Health checks

  • I create and optimize comprehensive GMP documents in accordance with Good Documentation Practice (GDocP), including Standard Operating Procedures (SOPs), Site Master Files (SMFs), Test Methods & Work Instructions, Job Descriptions, Qualification and Validation Plans, and complete Quality Assurance (QA) System documentation.

  • A GMP Documentation Health Check involves a focused review of up to 5 of your critical GMP documents or SOPs. You'll receive detailed feedback on compliance gaps, structure, and audit readiness, as well as concrete recommendations for action.

  • A Deviation Management Health Check provides a comprehensive review of your deviation and CAPA management processes. I analyze your root cause investigations and corrective actions, offering practical recommendations to optimize your system's compliance and efficiency.

  • A GMP Gap Analysis is a comprehensive on-site assessment where I evaluate your current Quality Management System (QMS), operational processes, and documentation against specific GMP, GACP, or other GxP regulatory requirements. It's crucial for identifying compliance deficiencies, understanding associated risks, and developing a strategic roadmap for effective remediation and continuous improvement. It provides a clear snapshot of your current compliance status and a path forward.

Do you have experience with digital GMP systems like LIMS or Trackwise?

  • Yes, I possess in-depth expertise in digital solutions such as Laboratory Information Management Systems (LIMS), Enterprise Resource Planning (ERP) systems, and digital deviation and CAPA management tools like Trackwise.

  • I advise and support you in the selection, implementation, and optimization of digital quality systems to efficiently, paperlessly, and with high data integrity map your GMP processes. The goal is improved compliance and process efficiency.

Here you'll find answers to the most common questions about my GMP compliance services, training programs, and audit solutions. If your question isn't covered here, please don't hesitate to contact me directly – I'm here to provide personal assistance.

Questions about Training