Standard Operating Procedures (SOPs) should comply with regulatory requirements (e.g. GCP, GDP, GMP) through corresponding conception, design and implementation.
We give answers to frequently ask questions about
- GDP, Wholesale license
- GVP, GCP processes and compliance
- GMP tasks, terms and definitions,
- links to other areas such as Regulatory Affairs, as well as
- uptodateness and completeness, validity
and support you with
- SOP preparation,
- review, assessment and update of SOPs,
- planning and completion of underlying processes,
- integration in your Quality Management system,
- establishment of interfaces with other areas (e.g. Regulatory Affairs),
- and efficient training.
We further give advice and implement solutions if
- oversight and links between processes are missing,
- SOPs are physically available, but do not reflect reality,
- SOPs are not regularly checked for uptodateness,
- SOPs are not updated in time or
- SOPs are not trained in time before release
- appropriate communication of process documents is missing,
- employees do not work with the current version.
Please feel free to contact us for a personal consulting. We are looking forward to your enquiry.