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
Cleaning Validation: Solubility is Important - but not a Solution
Solubility has been the most common objection for the use of Total Organic Carbon analysis for cleaning validation or verification studies for years because of the traditional, product-specific focus that is built into existing cleaning programs. This video shows how GE Analytical Instruments is are helping companies move on from solubility when it comes to cleaning validation.
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 ...
-
Validation of the Autoclave is classified into the following 1.0 OQ – Operational Qualification 2.0 PQ – Performance Qualification The valid...
-
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...
No comments:
Post a Comment