Creation of process descriptions (SOP)
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.