Build the Ideal Contamination Control Strategy CCS
The CCS is designed to ensure quality risk management is built into every pharmaceutical process from the ground up, and every quality decision made has a foundation in scientific reasoning.
Tag: annex 1
CASE STUDY: Sterility Test Isolator viable non viable contamination control solution
In this video interview, the team from AUSTAR UK discuss why and how they worked with Particle Measuring Systems’ (PMS) exclusive UK distributor, EMS Particle Solutions, to provide an AUSTAR sterility test isolator customer with a complete viable and non viable particle counting solution using PMS instrumentation and equipment.
Cleanroom Monitoring System per Annex 1 draft
Cleanroom Monitoring v. Classification v. Cleanroom Qualification Per EU GMP Annex 1, rev 12 draft There is little overlap with cleanroom monitoring and qualification and classification as seen in the image here: The goal of a cleanroom monitoring system is to assess the potential contamination risk of the product. The…
Cleanroom Qualification
Cleanroom Qualification – Classification – Monitoring Per EU GMP Annex 1, rev 12 draft The definition for Cleanroom Qualification is “The overall process to assess the level of compliance of a classified cleanroom with its intended use.” That is, classification is a part of qualification. Qualification methodologies are identified in EU…