Qualification/Validation

Qualification:Qualification-V-Model

The erection of plants for the production or packaging of pharmaceutical products requires the compliance with the GEP as well as with the official GMP requirements. These GMP (cGMP) requirements and directives for pharmaceutical and biotechnological plants are specified by national laws and provisions such as the Medicine Law, plant regulations or international laws and directives such as the EU GMP guidelines or the FDA requirements.

Ensuring product safety and, as a consequence, patient safety requires the documented execution of a thorough qualification procedure to make sure that a plant was engineered and erected in accordance with the intended requirements and specifications and that this plant also operates as required and specified - i.e. that this plant is qualified.

A qualified plant is the essential basis for the following validation of the processes.


Validation:
Validation is the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results, i.e. that a medicine/pharmaceutical agent may constantly be reproduced in the required quality which is a basic prerequisite for the approval of a medicinal product.

UTG's Competence in Qualification:
UTG has been engineering pharmaceutical and biotechnological plants for more than two decades now and has gathered wide experience in realising projects in GMP-related areas for various well-known customers. Based on our expertise in plant design we extended our range of competence by deepening our knowledge of qualification and providing more and more assistance in this significant field to our customers.

Depending on our scope of services provided for the individual projects, we have carried out qualification activities from the DQ to the OQ such as review and approval of engineering documents, participation in GMP risk analysis, execution of acceptance tests, FATs and SATs, incoming goods inspection, carrying out installation inspections, etc. up to function tests and test runs.

Following the general tendency of the industries to minimize the number of suppliers and thus interfaces in the realisation of projects or to award contracts as an overall package to one single company, we have extended our portfolio of services and supplies to be able to offer our customers the whole range from the engineering to the qualification and validation.

Our Range of Services
  • Management
  • Assembly and leading of a validation team
  • Coordination of interfaces
  • Planning and control of procedures
  • Planning and execution of supplier audits for our customers
  • URS (User Requirement Specifications)
  • Preparation of URS in cooperation with our customers
  • Preparation of specifications based on these URS (DS, FS)
  • Classification of plants and systems (critical or uncritical in aspects of GMP)
  • Determination of GMP-critical plant units or systems which need to be qualified and examined in detail in risk analysis
  •  VMP /QMP
  • Preparation and maintenance of validation and qualification plans and determination of qualification strategies
  • Risk analysis   
  • Preparation and execution of GMP risk analysis together with the customer to identify and minimize possible product risks and determine the required qualification activities for the DQ, IQ and OQ
  • Traceability matrix
  • Preparation, distribution and control of the TM for every supplier or plant unit based on the URS, inquiry, purchase order, etc. to have documented proof that the relevant specifications have been met.
  • Test plans, Check lists
  • Preparation and implementation of test plans and check lists which are relevant for the customer-related qualification procedure
  • Qualification of Existing Equipment / Necessity Assessment
  • If required, we audit already existing plants, equipment and systems as well as the related documentation and review the possibility of a retrospective qualification.
  • Execution of retrospective qualifications
  • DQ Design Qualification
  • Planning, execution and documentation of the DQ
  • Documentation verifying that the design documents (engineering documents) meet the requirements of the validation and/or qualification plans.
  • IQ Installation Qualification
  • Planning, execution and documentation of the IQ
  • Provide documented proof and inspection that the installations have been carried out in accordance with the specifications.
  • OQ Operational Qualification
  • Planning, execution and documentation of the OQ
  • Provide documented proof that the plant / equipment operates as specified under all specified conditions.
  • PQ Performance Qualification
  • Assistance in planning, execution and documentation of the PQ
  • Provide documented proof that the entire plant with all its associated plant parts operates safely and within the specified limits.
  • Qualification Reports
  • Preparation of the final qualification reports for every qualification stage which form the basis for the successful audits of customers and/or authorities at our customer.
  • FAT/SAT
  • Planning, execution and documentation of FATs/SATs with the customer and the suppliers
  • SOPs
  • Preparation of general and assistance in the preparation of customer-specific SOPs
  • Change Control
  • Change control, management and documentation within UTG's scope of supply
  • Safety Reviews
  • Planning, execution and documentation of safety reviews (personnel and plant safety) with the customer
  • Maintenance and Calibration Schedules
  • Preparation or assistance in preparation of maintenance and calibration schedules based on the results of GMP risk analysis, safety reviews and supplier instructions
  • Training
  • Preparation of training schedules and moderation of trainings for our customers
  • Documentation
  • Preparation of a comprehensive and traceable qualification documentation

Contact:

 

Richard UmhackRichard Umhack

Qualification/Validation

E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Tel.: +43 (0)316 682720-25

Fax: +43 (0)316 682720-9