Steps in the Validation Process

What are the stages of the Validation Process?

First up, we have the VMP (Validation Master Plan): This is a key document in the pharmaceutical and medical device industry that is subject to GMP and FDA regulations. This document relates to all processes in the facility, such as validation of a process, or certification and validation of a facility and services, certification of equipment, or the validation of cleaning and computer systems.

This document presents a structured approach to validation projects and includes:

  • Details of the basic principles for the certification of a production facility.
  • Defining which areas and systems should be validated / verified.
  • A written plan for the establishment and maintenance of a certified facility.
  • Justifications based on risk assessment regarding the inclusion / omission of systems from the validation program.

Equipment Qualification – Why do we need Qualification?

Next up, we have Equipment Qualification, which is important due to the following:

  • Ensures compliance with regulatory requirements.
  • Ensures control over equipment and facilities.
  • Reduces errors, accidents, rework, product recalls and customer complaints.

User Requirements Specification (URS)

Next in line: the URS is a document that constitutes a basis for validation and which was written at the preliminary planning stage by the user. It includes:

  • Definition of technical requirements, quality requirements and required documentation from the equipment supplier.
  • Assessment of the degree of conformity of the equipment from a technical / regulatory / commercial aspect to an official specification.
  • Acceptance criteria for compliance with the defined requirements.

DQ – Design Qualification

This is the stage at which the equipment is chosen based on the specifications, and includes:

  • Specific capabilities such as range of operation, and capacity.
  • Defined requirements such as dimensions, and material resistance.
  • Additional qualities such as ease of use, manufacturer reputation, previous experience with similar models, warranty, and support services.

IQ – Installation Qualification

At this stage, the IQ determines the following:

  • Checks the status of the equipment upon reception – that the correct item has been received in its entirety (including accessories), there are no defects, and documentation dates / time of receipt.
  • The intended location is examined in terms of dimensions and requirements of supply voltage (adjustment of plugs, voltage / current adjustments).
  • Checks whether the equipment passes an initial setup – including booting up / electrical safety check.
  • Schedules maintenance, calibration and cleaning schedules.

OQ – Operational Qualification

At this stage, the OQ includes:

  • Ensures the equipment is operating as defined by the manufacturer by checking the relevant operational parameters (such as whether the equipment is running at the set temperature, and if the temperature is stable).
  • Checks the operation of the alert system when exceeding defined limits.

For more information – please contact our validation experts.