A validation plan (VMP) outlines the scope of the work to be done, responsibilities, the approach to be taken etc. It may relate to a new product or a new system or the qualification of your computer network.
The validation protocols are the documents with tests and instructions that are executed for a process, equipment validation or analytical method validation etc. These are cited by the VMP as being required.
A VMP is not always required and is dependant upon the size of the project, whereas you will nearly always have validation protocols in some way shape or form.
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
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