VALIDATIONS AND QUALIFICATIONS

KIRANTONI SRL provides services for the qualification of equipment in the pharmaceutical industry in accordance with GLP / GMP requirements and regulations.

 

GLP principles ( Good Laboratory Practice  )  are principles of good laboratory practice, that are consistent in a  system of rules and regulations aimed at ensuring the consistency and reliability of laboratory results.

 

The Good Manufacturing Practice (GMP) principles ensure that products are manufactured and controlled consistently to the quality standards appropriate to their use and to the requirements of the Registration Certificate or the specification of medicines, medical devices, diagnostic products, food, food additives and active ingredients.

 

Validation is the action that proves, in accordance with GMP principles, that any procedure, process, equipment, material, activity or system actually leads to the expected results. In the specific case of equipment, qualification is the main tool of the validation process.

 

Qualification consists in performing the specific tests and drawing up the related validation protocols: IQ; OQ; PQ - Qualification of Installation (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).

 

Installation Qualification Protocol (IQ):

The Installation Qualification Protocol verifies the proper installation and configuration of a System. This can include ensuring that necessary files have been loaded, equipment has been installed, the necessary procedures have been approved, or the appropriate personnel have been trained. The requirements to properly install the system were defined in the Design Specification. Installation Qualification must be performed before completing the Operational Qualification or Performance Qualification..

 

Operational Qualification Protocol (OQ):

The Operational Qualification Protocol is a collection of test cases used to verify the proper functioning of a system. The operational qualification test requirements are defined in the Functional Requirements Specification. Operational Qualification is usually performed before the system is released for use..

 

Performance Qualification Protocol (PQ):

Performance Qualifications are a collection of test cases used to verify that a system performs as expected under simulated real-world conditions. The performance qualification tests requirements defined in the User Requirements Specification (or possibly the Functional Requirements Specification). Sometimes the performance qualification is performed by power users as the system is being released. Depending on your needs and the complexity of the system, Performance Qualification can be combined with Installation Qualification or Operational Qualification.

 

KIRANTONI SRL provides qualification services, which consist in performing the specific tests and drawing up the related validation protocols for the following types of devices:

 

  • gas and liquid chromatographic systems, whether or not coupled to mass spectrometry detectors
  • sectrophotometric absorption and / or emission spectrophotometric systems
  • dissolution test systems; disintegration tests; tests of hardness determination, friability, equipment for research and development;
  • autoclaves, ovens, incubators, climatic rooms;
  • material testing machines;
  • weighing apparatus; balances, thermogravimetry;
  • titrators, pH meters, oxygenometers, etc.

 

KIRANTONI SRL has an experienced staff, trained and authorized by the manufacturing companies in the field of installation, use, maintenance, qualification of laboratory equipment, offering promptness at competitive prices.

 

KIRANTONI SRL specialists will be available throughout the complete validation / qualification process to harmonize the requirements of internal or external auditors