Quality Assurance Professionals
Quality assurance is a vital component of drug development and contract manufacturing within the virtual pharmaceutical world. It's the branch that is responsible to guarantee that all appropriate methods and controls have been completely adhered to and that documentation is in place to ensure that scientific development was done to regulated standards.
The discipline of pharmaceutical quality assurance contains a vast array of concepts that that independently or collectively have an effect on the caliber of a product. However, it was defined quite simply and eloquently by Phillip Crosby, one our industries leading quality gurus. He maintains that the definition of quality is conformance to requirements, not as goodness.
Our At PharmaDirections, our Quality Assurance professionals understand and practice the art of conformance and are experts at evaluating it. They are available for any task large or small. We can conduct GMP audits, review your batch records or design a complete quality system.
When we manufacture with InstantGMP™, our proprietary manufacturing execution system, quality(conformance to requirements) is built in. We designed InstantGMP using a “Quality by Design” approach. The entire quality system, the SOPs and the database programming were designed and written in parallel. The quality checks required by the SOPs are built into the database application so there is a level of control that is unprecedented in electronic manufacturing systems.
Our Quality Assurance personnel can use our this unique manufacturing execution system at any qualified production facility. Our clients can see how their regulated products are progressing through secured screens that are specific for their program. They can even provide their own QA sigoff on GMP documents such as vendor certification, specifications, master production records or batch production records – all done remotely using our secured web pages.