RAPS

Euro Roundup: EMA consults on planned update to computerized systems annex of GMP guide

The European Medicines Agency (EMA) is seeking feedback on the planned revision of the good manufacturing practice (GMP) annex on computerized systems. The agency wants to revise the existing text, ...
RAPS

EMA Consults on GMP Reflection Paper

The European Medicines Agency (EMA) this week released a draft reflection paper for consultation outlining the good manufacturing practice (GMP) responsibilities applicable to marketing authorization ...
JD Supra

Dutch authorities to focus on computerised systems during GMP inspections

The Dutch authority carrying out GMP inspections, the Health and Youth Care Inspectorate (IGJ), announced it will carry out a series of pilot inspections focussing on the validation of computerised ...
PharmTech

Risk-Based Life Cycle Management of Master Production and Control Records to Strengthen Data Integrity and GMP Inspection Readiness Part 1: Regulatory Framework, Inspectional ...

Regulatory expectations align across WHO, EU, PIC/S, and Health Canada; US 21 CFR 211.186/211.188 define MPCR content and faithful BPCR reproduction. Inspection trends highlight uncontrolled page ...