Ensure Successful Batch Release, Regulatory Compliance with Experienced Qualified Persons

Streamlining a CMO’s manufacturing process helped ensure GMP compliance for EU batch release and USA inspection readiness.

A contract manufacturing organization (CMO) needs to have a reliable quality management system in place to meet clients’ needs and comply with Good Manufacturing Practice (GMP). Additionally, in Europe, a Qualified Person (QP) is required to certify every batch before it can be released to the market.

Find out how ProPharma Group supported the CMO by streamlining the manufacturing process to ensure that it was GMP compliant for EU batch release and assisting with USA inspection readiness.

Case Study

Share

Infographic

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Webinar

Free Webinar: Effective FDA Engagement

FDA faces challenges (like new technology) and new review models (like real world evidence) that stretch agency standards and practices. At the same time, imperatives like product safety and efficacy...

Infographic

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...