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QUALIFICATION AND VALIDATION

Uniservice is one of the few companies ready to provide customers with services for performing this type of work. Our company's specialists were involved in this type of activity even before the company's establishment and were pioneers in the field of qualification and validation in pharmaceutical manufacturing enterprises.

We conduct qualification of all systems and equipment in the chemical-pharmaceutical, biotechnological industries, laboratories, medical device manufacturing, and healthcare sectors. Our experience can also be applied in the electronic and mechanical engineering industries. Our company possesses a wide range of certified equipment and trained qualified personnel.

The company's specialists always collaborate with the client in the form of validation groups. Before commencing qualification and validation, we prepare validation protocols according to the customer's requirements. Upon completion of testing, we develop a report on the performed work, describing the testing process, documenting measurement results, and evaluating the entire qualification.

We perform all types of qualification and validation according to GMP requirements and ISPE directives, which include the following components:

  • Development of a Validation Master Plan (VMP)
  • Project Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Process Qualification (PQ)
  • Process Validation (PV)
  • Cleaning Validation (CV)
  • Requalification
  • Revalidation

During equipment delivery, additional testing is conducted both at the manufacturer's factory and subsequently at the installation site (Factory Acceptance Testing - FAT and Site Acceptance Testing - SAT).

In the pharmaceutical industry, we conduct qualifications, validations, requalification, revalidation, and monitoring of all systems and equipment:

1. "Systems for generation and distribution":

  • Water for Injections;
  • Purified Water;
  • Clean Steam;
  • Compressed Air;
  • Vacuum;
  • Process Gases;

2. Systems and Components:

  • Product pipelines and material pipelines;
  • Air preparation for manufacturing (including 'clean') rooms and zones;
  • Cleanroom Constructions;
  • Systems of automation, dispatching, visualization, and archiving of operational parameters of engineering systems;

3. Primary and auxiliary technological equipment and systems;

4. Validation of analytical methods, equipment cleaning methods, and manufacturing process technology.

Proper qualification and validation not only ensure compliance of equipment, systems, elements, processes, etc. with industry standards but also contribute to optimizing the Customer's costs (both capital and operational). This is achieved by substantiating and providing proper empirical evidence of compliance for various engineering solutions, which may not always be technically complex and/or costly to implement.