Our modern quality management approach regulates all audit-related matter
Neutral QM supervisory board (APM board).
The APM Board, which is composed of 3 members from a pharmaceutical background with extensive experience in the areas of auditing and quality assurance, ensures we have a functional quality management system that in turn guarantees the quality of our audits.
Valid processes and procedures – based on experience.
Audit Programme Management (APM) ensures seamless implementation of the valid processes and procedures.
Experienced, qualified, independent auditors.
Passionate auditors are permanently employed or linked to our quality management system on a contractual basis. The APM board verifies their qualifications and suitability for the task at hand. In each case, the independence of the auditors in respect of the party being audited is guaranteed.
Valid auditing procedure:
Our audits are performed on the basis of a long-established, valid process:
Phase 1: Preparation
- Offer specifying audit content and scope
- Selection of auditors based on content and standards to be applied
- Clarification of audit details
- Scheduling and travel planning
- Creation of audit plan (agenda)
- Audit plan is sent to the company-to-be-audited at least 4 weeks before the audit,
Phase 2: Auditing
- Introductory talk, introduction of participants
- Introductory presentation by auditee
- Tour of operating premises (incoming goods warehouse, production, quality control, final product warehouse)
- Examination of documents (SOPs, batch records, training, quality review, etc.)
- Closing discussion with all participants
Phase 3: Follow-up
- Creation of audit report (up to approx. 4 weeks after the audit)
- Communication of findings to auditee and preparation of planned measures
- Final assessment of corrective actions by the head auditor (up to approx. 10 weeks after the audit)
- Follow-up on implementation of planned corrective and preventive actions by the auditee for major and critical defects
Introduction of the APM board members
Dr. Dieter Bloß (Head of APM Board)
Dr Bloß has a PhD in Chemistry and has had a long career in medium-sized pharmaceutical companies. He held a number of positions at G. Pohl Boskamp, including Head of Quality Control, Vice President of Scientific Affairs, Senior Director of Quality Control and 10 years as Qualified Person before retiring in 2015. Today, Mr Bloß dedicates his time to the pharmaplace QM system.
Dr. Marcus Niehörster (APM Board member)
Dr Niehörster has worked all over the world as an auditor, expert advisor and consultant for authorities and pharmaceutical companies for over 25 years. He spent more than 20 years working as a consultant, auditor and trainer for PCS GmbH in his role as Managing Director. He is a professionally qualified Senior GMP Compliance Expert and Senior GMP Auditor, and has been a GMP expert for the Swiss Accreditation Service SAS for 15 years.
Dr. Bernd Hasken (Head of APM + APM Board member)
As an employee of pharmaplace AG, Dr Hasken has been successfully heading up the company’s audit programme since 2015. A qualified auditor with a PhD in Chemistry, he co-founded and established the shared audit programme and the APM Board in its current form. In addition to managing the audit programme, he works all over the world as an auditor for pharmaplace.