Validation
A comprehensive on site service is provided by our validation department. Primarily focused on, but not limited to validation of pharmaceutical applications (PSC-PSR stability and PSC photostability models).
Overseas our extensive dealer network conduct on site validation activities utilising Weiss Gallenkamp. generated protocols.
Validations are conducted utilising the following protocols: IQ-OQ-PQ protocols for validation of new and existing installations. PQ protocols for validation of Weiss Gallenkamp . or non Weiss Gallenkamp . installations. PV protocols for periodic re-validation of installations. Protocols are based upon a standard industry format and contain one test per page. Each page typically contains the test objective, method, acceptance criteria, equipment reference, comments section, corrective action section and validation engineer and customer sign off sections.
Initial and periodic validation allow the customer to build an auditable history for their equipment. Therefore demonstrating compliance with ICH (International conference on harmonisation -Tripartite guidelines. Stability guideline (Q1A) and photostability guideline (Q1B).
Our validation clients include many of the largest pharmaceutical companies in the world. We have specifically trained validation engineers who are fully conversant with product specifications, instrumentation, and regulatory and audit requirements.
To assist users less familiar with our validation activities we can offer a Validation master plan (VMP) which outlines, each protocols typical content, aims, objectives, acceptance criteria etc. Customer's specific document numbers are incorporated in all protocols to conform with validation requirements.
On site validation activities take typically 4-5 days (IQ-OQ-PQ). Within our standard price regime, two twenty four PQ tests are conducted. Tests are conducted at one temperature and humidity setpoint, loaded and unloaded or two temperature and humidity setpoint conditions loaded. Each PQ test has a five-minute intrusion test as standard.
PQ/PV testing is conducted utilising 21 CFR part 11 compliant dataloggers. Therefore each customer has total assurance regarding the validity of datalogged results, as all files are binary encrypted, secure, unalterable files. We are able to datalog upto 18 temperature and 12 humidity points.
We also regularly undertake Performance qualification of pharmaceutical storage facilities from other manufacturers. Examples being low temperature freezers, refrigerators, ovens, and incubators.
