While documents and documentation have been the mainstay of compliance in the pharmaceutical industry for years, the advent of new digital technologies is opening up vistas to a better approach to validation.
Readers are invited to participate ad contribute questions, answers, and discussion for this series – please share your successful practices with other readers. This column succeeds when we are able to address current GXP issues submitted by interested readers.
Cleaning methods for pharmaceuticals are developed and validated for use in the cleaning of manufacturing equipment. Are these same methods required to be used in the analytical laboratory for cleaning glassware, tubing, and other analytical equipment? Must these laboratory cleaning methods also be validated?
Cold chain storage practices have come under scrutiny from auditors and regulatory agency inspectors in recent years. Chamber qualification for temperature controlled equipment intended for storage or for vessels intended to be used during shipping is now a regulatory expectation.
This article illustrates product, process, production, and validation differences between the two healthcare industries, and provides suggestions on what pharmaceutical process validation guidance contents/concepts we can or we cannot borrow.
A key fundamental of any pharmaceutical quality system is that companies must fully understand how their critical data is performing. Evidence suggests that most companies do have reasonable periodic review strategies in place for Computer System Validation and Process Validation.
The writing of validation documents is often a problem in pharmaceutical and related organizations. This discussion builds on PQ Forum #10: Technical Writing for Validation (1) and more thoroughly describes a specific stepwise approach to writing validation documents. A structured approach for writing documents using technical writing principles...