Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices | Videos
Contract Research & Services
Contract Services
Return to: PBR Home | Contract Research & Services | Contract Services | Suppliers

NSF: Learn from a Fabulously Successful GMP Remediation Program

Published 06 March 2017 | By NSF Health Sciences Pharma Biotech PBR

This White Paper describes a remediation program that appeared at first to be impossibly daunting, expensive and unattainable. The company had received a range of critical and major GMP deficiencies from the UK regulatory body, MHRA, and was facing a referral to MHRA’s Inspection Action Group. Manufacturing had to be suspended pending a risk assessment of the non-compliances; evaluating the effect of the non-compliances in terms of risks of misbranding and adulteration of the products. Shifts were cancelled, the supply chain was suspended and an urgent remediation program begun.

Available Downloads

NSF: Learn from a Fabulously Successful GMP Remediation Program