Quality management (QM) refers to all organised measures that serve to improve products, processes or services of any kind. To ensure the quality of pharmaceutical products, companies are required by law to implement and maintain a quality management system.
"Quality as the ultimate goal" is the guiding principle of PharmSec when setting up and implementing quality systems in the GxP environment. Besides the consideration of the complete product life cycle, patient safety is the first priority. Through an individual risk-based focus on the activities carried out, the system is scaled to the necessary extent and complexity, and all this, of course, while ensuring a continuously high quality standard in compliance with regulatory requirements.
- Establishment of a pharmaceutical quality system
- Establishment of a QS system according to GDP
- Creation of the complete SOP landscape
- Creation of a QM manual
- staff training
- Support in implementing elementary management processes (document management, deviation management/CAPA, change management etc.)
During ongoing operations PharmSec supports the use of standardized processes as well as the sensible application of quality assurance systems. The optimal integration of the employees into the process landscape ensures that the individual workflows are clearly reflected. Further core aspects are the continuous improvement and development of existing processes with a focus on quality and patient safety as well as ensuring regulatory conformity and timeliness.
We would be pleased to assist you with our expertise in the following topics:
- Criticality analysis of the outsourced process
- Qualification - risk-based assessment of "GMP/GDP competence
- Contract negotiation and drafting
- Ongoing assessment of the cooperation in daily business
PharmSec offers a "complete auditing package" from planning to execution and follow-up. The audits meet the requirements of DIN EN ISO 19011 (Guidelines for the auditing of management systems) and are carried out on the basis of the currently valid GxP regulations as well as taking into account internal company requirements. Of course, individual services are also possible as an option:
- GMP audits of manufacturers of active ingredients, excipients and packaging materials, as well as contract manufacturers and contract laboratories
- GDP audits of wholesalers, logistics companies, forwarders and external warehouses
- ISO audits of technical suppliers and service providers in the secondary GxP environment
- Organizational planning (making the first contact with the organization to be audited, coordination of appointments, agenda)
- Preparation of content (determination of the audit focus depending on the customer-specific requirements, possible document review in advance)
- either independently on behalf of the client or accompanied by the client (definition of fixed roles and responsibilities)
- Creation of the audit report, execution of audit follow-up actions (for example, follow-up of corrective actions)