Why Every GMP Pharma Manufacturer Needs a CPV Software Solution — And What to Look For
The Problem With "Good Enough" Process Verification Picture this: your batch data lives in three different spreadsheets. Your QA manager is manually calculating Cpk values every quarter. Your regulatory team scrambles to pull together CPV reports before an FDA inspection. Sound familiar? Approximately 20% of pharmaceutical manufacturing companies are likely not complying with current GMP requirements when it comes to CPV, while 50% are complying but not using the full outcomes of the information their data provides. Rephine That means only around 30% of manufacturers are truly getting the most out of their process verification programs. If your organisation falls into the first two categories, you are not alone — and you are not without options. What Is CPV, and Why Does It Never End? Continued Process Verification is the collection and analysis of end-to-end production components and process data to ensure product outputs are within predetermined quality limits. ISPE What m...