Quality Management System
Our Quality Management System (QMS) is documented on four levels:
- Level 1 Quality Manual and Site Master File
- Level 2 Standard Operating Procedures
- Level 3 Records and Documentation
- Level 4 Review of Records and Documentation
The QA Manager is responsible for liaising with the relevant departments to carry out the following activities in order to meet necessary requirements for our services:
- Implementation and maintenance of the QMS
- Preparation of various quality plans (including training, and quality improvements)
- Review of the QMS
- Planning, scheduling and coordination of internal and external quality audits
- Identification and preparation of quality records
All key tasks in the organization have been described in Standard Operating Procedures (SOPs). The SOPs are fully compliant with current GxP and are issued to all personnel defined as being affected by the procedure.
The performance of the QMS is examined at least once a year by a management review team. Internal audits of the Quality System are undertaken at regular intervals to confirm that SMERUD’s applicable procedures are compliant with current regulations and that the function concerned is adhering to SMERUD’s procedures. A comprehensive audit program is compiled at least a year in advance however, should particular needs be identified, the audit program can be amended as appropriate at the discretion of the QA Manager.
The policy of the company is to ensure that all personnel are trained and experienced to the extent necessary to undertake their assigned activities and responsibilities effectively. The company generally procures and recruits employees capable of meeting the technical skill, experience and educational requirements of the company’s activities. All staff participates in an annual training program, which covers i.a. all key SOPs and GCP refresher training. Full records are maintained of all training undertaken by employees.
ICH-GCP and Monitoring
Strict compliance with ICH-GCP is key to our operations. Our QMS is fully compliant with ICH-GCP R2. A complete set of SOPs is available to cover all aspects of ICH-GCP. Our staff receives a full GCP refresher training every two years and is trained on the GCP compliant SOPs to ensure that all our work is conducted in accordance with GCP. Further, our CRAs ensure that site staff is properly trained on GCP and that the site activities are GCP compliant. Work performed by the site (incl. GCP compliance) is continuously monitored by the CRA. Work performed by SMERUD project staff (incl. GCP compliance) is supervised by a SMERUD project manager. In addition to the hands-on, project specific follow-up, compliance is monitored by internal audits.
As a result of being a consultancy we are frequently audited by our clients, which gives us a valuable independent review of our GCP compliance. Audits from the last three years have revealed no major or critical findings related to our company’s GCP compliance.