V:Kit Software Platform with Dissolution Protocols
A range of test templates with SOPs for Tablet Dissolution apparatus 1, 2 and 4, for delivery and execution by V:Kit software.
The supplied protocols include Mechanical Qualification (MQ), Performance Verification Testing (PVT) and Enhanced Mechanical Qualification (EMC) tests to satisfy USP 711, Ph. Eur., ASTM and FDA requirements.
V:Kit's flexible, protocol designer tools allow users to build customised protocols for any bath/vessel/paddle/basket configuration including any associated HPLC and UV-Vis systems (Note: HPLC and UV-Vis protocols must be purchased separately).
Standard Operating Procedures
Each test design contains a SOP which is directly accessed from the software. They are centrally distributed and are only accessible by authorised users. Full version control is enabled, and obsolete versions automatically archived, preventing use of out of date procedures.
Each SOP provides instructions on how to execute the test and documents the formulae and calculations used in the data evaluation. This assists the process of data checking by Quality Assurance or external auditors.
Certificates of Analysis
COAs are directly accessed from the software, which automatically extracts and embeds the analytical data directly into the test protocol. This avoids transcription errors and prevents accidental use of out of date materials.
The COA of a batch of a standard used in a OQ/PQ test can be electronically attached to the qualification report. So no more photocopies or poor quality scans….
V:Kit COAs follow ISO guidelines regarding certified values, intended use, homogeneity, storage, hazard and quality information.
Operational Qualification Test Templates
- System Configuration
- Paddle/Basket Depth
- Rotational Speed
- Shaft Wobble
- Shaft Verticality
- Basket and Paddle Wobble
- Vessel/Shaft Centering
- Vessel Verticality
- Vessel Plate Level
- Vessel Temperature
- Preparation for PVT - Media and Standards
- Performance Verification - Prednisone, Paddle/Basket