Quality Is Our Sustainable Asset
Need of Qualification
Qualification Startup
To initiate the qualification of pharmaceutical equipment a frame work before startup is required:
Qualification service
Facility Qualification Scope includes: Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ)
User Requirement Specification
User Requirement Specifications consist of Design Specifications and Functional Specifications. Design Specifications provide explicit information about the design requirements for equipment e.g. the dimensions, material of construction, layout, etc. Functional Specification denotes how each feature of the equipment/system must function.
GOST Company Introduce all wide types of testing as next:
Installation Qualification
Installation qualification test consist of checking of:
Presence of all components of the equipment ,Damages to the component ,Design features of all critical component e.g. dimension, make, model, Material of Construction etc. ,List of Instruments requiring qualification, Utility connection against applicable specification, Availability of required documents , Verification of drawings, Assembly of components against the manufacturer’s recommendation.
Operational Qualification
Performance Qualification
The PQ integrates procedures, personnel, systems, and materials to verify that the pharmaceutical grade use, environment, equipment, or support system produces the required to be output. This output may be the product or product contact use (cleanse compressed air, purified water, etc.) or environment (HVAC system). Acceptance criteria should be clearly indicated in the PQ document.
The PQ is the final stage of qualification, which demonstrates how equipment/system will perform under simulated or actual production or operating conditions.
This series of tests is designed to demonstrate that the equipment/system is capable of consistently operating and manufacturing product of specified quality in the worst case. This phase can only be undertaken once the operating parameters have been defined and approved.
Re-Qualification
Re-Qualification is an activity involving complete or portions of ‘elements’ of qualification activities, like IQ, OQ and PQ.
Re-Qualification carried out for one or more of the following reasons: To address deficiencies observed in an executed qualification, To qualify changes done in the equipment or a process involving the equipment, Failure, CAPA, Findings/Recommendations from Inspections/Audits/ PQR, etc. Inputs from Preventive Maintenance/Calibration Program, Equipment Up-gradation.