A documented quality system is the backbone of Good Manufacturing Practice and Good Distribution Practice.
If you need a Site Master File, a Quality Manual, Standard Operating Procedures written or reviewed, we can help. We can also assist with Product Quality Review.
We offer a bespoke service for GMP documentation needs.
Case Studies
Company A was an importing company. They had a Site Master file and a set of Standard Operating Procedures, but they were all at least 2 years out of date. They had an inspection due in two months.
Spheriqual Ltd were able to re-write the Site Master File and update all of their SOPs in time for the inspection.
Company B had Standard Operating Procedures but they were very basic, and they had no Site Master File. Spheriqual Ltd supplied a Site Master File and helped with revision of their SOPs. We also assisted with the preparation of their Product Quality Review by supplying a template and advice on the content.