Qualification and Validation; PV and CV – risk based approach

We offer comprehensive and protocol based support to your team to meet with the overall requirement of qualification and validation of the Organization. We follow science and risk based approach, integrate performance qualification with process validation, containment, bio-safety, contaminants from the entire realistic sources in the manufacturing of pharmaceutical, bio-pharmaceutical and optical fibre.

Qualification and Validation:

Risk based approach – Conventional and ASTM 2500E for Facility, Equipment, System, Practice and procedure;

Formation VMP from detailed engineering to the state of validation - protocol & report and periodic assessment;

Qualification, Re-qualification based on performance history and impact assessment;

Integration of Periodic performance validation, change management and compliant documentation;

Oversee Facility, Utility, Equipment, Instrument, Storage, Containment, Software qualification and validation to ensure ‘fit-to-use’ state in close co-ordination with the Vendor;

Development and review of URS, DQ, IQ, OQ, PQ, RQ, etc and practical training.

Process Validation – perspective & concurrent:

Process design;

Process Qualification;

Scale-up validation – laboratory scale, engineering scale, exhibit and commercial scale;

Leachable, extractable, containment validation.

Cleaning Validation and Clean down Verification:

Worst case based on solubility, safety and toxicity for MACO, health-based exposure limit (HBEL) of product as per current guidelines;

Dirty hold, clean hold, Deactivation, existing molecule and addition of new molecule;

Domain NCE/API, OSD, Sterile, Bio-pharmaceuticals.