Quality management and system qualification

Nicro completely fulfills conditions for the high quality prescribed by the pharmaceutical industry, including GMP and regulatory requirements, as well as submission of the appropriate documentation.

The quality policy is based on ISO standards:

  • HRN EN ISO 9001: 2015 Quality management system
  • HRN EN ISO 3834-2 along with application of the PED - Directive 2014/68 /EU
  • EN 1090-2, EXC3 
  • HRN EN ISO 14001: 2015 Environmental management system

We work in accordance with directives: Atex (Directive 2014/34/EU) and the PED – Directive 2014/68/EU, depending on the system requirements and conditions.

Qualification includes the preparation of the installation and protocols, performing the installation qualification, functional testing of the system and final works.

 

DOCUMENTATION

Nicro Ltd. delivers project documentation in three parts:

  • General documentation
  • Technical documentation
  • Qualification documentation

1. General documentation includes the main project documents such as the quality plan (QP) and qualification project plan (QPP), Nicro certificates, equipment certificates and specifications of all system elements installed by Nicro Ltd.

2. Technical documentation:

  • Welding documentation which includes certificates for the welders, welding equipment and additional materials, approved welding procedures (WPQR) as well as the appropriate documentation on consumable welding materials. Welding is performed using orbital welding with a closed weldhead. Manual welds are performed in only exceptional cases.
  • Isometric drawings of completed works
  • Documentation on passivation and chemical treatment along with reports, chemical certificates and work procedures
  • Documentation on final controls
  • Documentation on pressure tests
  • Documentation on weld controls – NDT control (VT, PT, RT…)
  • 3.1b material certificates and results of surface roughness tests
  • Documentation on tanks and pressure vessels along with technical information, operation and maintenance manuals, risk assessment and CE documentation
  • Other technical documentation on equipment delivered by Nicro

3. Qualification documentation:

  • Design review along with technical specifications of equipment and elements which Nicro supplies and a traceability matrix with references to user requirements and qualification tests
  • Installation qualification plan, protocol and report
  • Execution of IQ / OQ

Protocol for installation qualification includes at least verification of the following:

  • Documentation
  • Appearance of piping
  • Surface of the product in contact
  • Welding / NDT control
  • Pressure test
  • Passivation

And all in agreement with the client.