validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
Monday, January 1, 2018
Understanding the Three Stages of Process Validation
While most professionals know there are three stages of the process validation lifecycle, many are unaware of the activities dictated by each stage. As part of IVT's pre-Validation Week webinar, Paul Pluta, Ph.D., explained the prescribed endeavors of Stage 1, Stage 2, and Stage 3 of process validation as recommended by the US Food and Drug Administration.
Subscribe to:
Post Comments (Atom)
Pharmaceutical Validation Documentation Requirements
Pharmaceutical validation is a critical process that ensures that pharmaceutical products meet the desired quality standards and are safe fo...
-
K. Dashora, D. Singh, Swarnlata Saraf and S. Saraf *. Institute of Pharmacy, Pt.RavishankarShuklaUniversity, Raipur 492 010. *Author for ...
-
Cold storage is a relatively simple cold room that is commonly used to store material between 2[degrees] to 8[degrees]C. Such cold rooms a...
-
Validation of the Autoclave is classified into the following 1.0 OQ – Operational Qualification 2.0 PQ – Performance Qualification The valid...
No comments:
Post a Comment