Manufacturing organization qualification procedure

Facilities to produce medicinal products for human use need to be qualified according to cGMP requirements.

Health Authorities qualify, after inspection, that production take place in conformity to cGMP standards.

According to national and international regulations, an applicant need to provide that his qualified cGMP manufacturing site has a Qualified Person at his disposal.

Staff should be qualified, competent and in compliance with legal requirements for production and controls.

Personnel should be adequate in number and qualified and trained for his specific mansion.

Operations, equipment and utilities need to be qualified to assess that results are as expected.

Qualification process includes: design qualification, installation qualification, operation qualification, performance qualification.

Procelltech can offer consultancy for drafting required documentation for Heath Authorities, including operative procedures, Site Master File and Qualification protocols for assays and processes.

Procelltech can assist in designing facilities in compliance with requirements for cGMP qualification.