What is a qualification in the pharmaceutical industry?


Qualification in the pharmaceutical industry

This article will try the qualification of equipment and services in the pharmaceutical industry. The purpose is to give an introduction to the world of qualifications. Given how extensive is this, it is impossible to treat in this article, so we will discuss the most relevant aspects and basic steps in the qualification of an installation.

The rating of a team, or facility, is a set of checks and tests performed on equipment in order to ensure that the requirements applicable regulations are met, is properly installed, operates and performs as expected, without have affected the product quality, patient health and safety of the operator.
These checks and resultadas test must be properly documented, following a series of very specific rules.

Phases of a qualification

A qualification has several phases that are listed below:

  • basic design
  • Detail design
  • Construction / Installation
  • Start up
  • Delivered to the user
  • Operation

Basic design phase

  1. User System Requirements
  2. Impact Analysis
  3. Risk analysis

Then we develop each of these stages.

Requerimientos User (URS - User Requirements Specifications)

This document describes the set of user requirements, technical and policy to design the equipment or installation. The URS is expected to describe what the system does, but not technical solutions to achieve it. Requirements should be as far as possible something that can be measured, as this facilitates verification of the following steps.

Each request shall be classified according to whether or not it is critical to product quality, patient health and safety of the operator.
All user requirements must be verified during the qualification system. It may be the case that a requirement be evaluated in over the qualification phase, or even parties.

For example, consider a requirement that is critical and is based on the temperature that must be maintained of the process in a reactor. At DQ will verify that the design of the system has taken into account the installation of a temperature transmitter, IQ will verify that is installed correctly identified and calibrated, and OQ will check your signal reaches SCADA. Further we develop the concepts of DQ, IQ and OQ.

Impact Analysis (IA - Impact Assessment)

This document describes the impact that the system can have on product quality, patient health or safety is assessed. It is classified according to the system the following relationship:

  • Direct impact: the agitator of a reactor.
  • Indirect impact: the CIP system of an installation, a line valves purified water.
  • No impact: TAR effluent pump drive.

System boundaries must be clearly defined before the analysis. For example, a HVAC system It consists of an air conditioner, chiller, conduits, valves, probes, etc.).
The result of this analysis will determine whether a team qualifies or commissions. Teams with direct impact will be qualified.
Teams with or without impact indirect impact will be installed and commissioned designed according to Good Engineering Practice (GEP - Good Engineering Practice).

Analysis riesgo (RA - Risk Assessment)

This document has the following functions:

  • Assessing the probability of failure, the impact and probability of detection of a requirement, according to the GMP criticality of risk associated with each request.
  • Defines the actions to take to reduce the risks of each requirement. These actions define the scope of the qualification and acceptance criteria for the test. They must be approved prior to execution of design qualification.
  • Dar trazabilidad de los requerimientos de usuario a las fases siguientes.
  • Comprobar que las acciones propuestas se han llevado a cabo durante la cualificación.

Detailed design phase

  • Plan de cualificación.
  • Cualificación del diseño.

Plan de cualificación (VP – Validation Plan)

At this stage will be established the strategy Installation Qualification. Aquí se determinarán los documentos que deben generarse, sus códigos, alcance, formatos, etc.
Se designan los departamentos intervinientes en la cualificación, sus funciones y sus representantes. Se presenta el timing del proyecto.
Aquí también se definirán los formularios para documentar las no conformidades y los controles de cambios dentro de la cualificación.

Cuando el resultado de un test no sea el esperado se debe documentar como una no conformidad. Éstas pueden clasificarse de acuerdo a su criticidad y a si permiten continuar o no con la cualificación. El registro consistirá en una descripción del por qué, una justificación de su clasificación, una propuesta de solución a la no conformidad y cuándo está previsto solucionarla.

When you should be amended facility design por algún motivo constructivo, de cumplimiento de normativas, etc. debe registrarse como un control de cambios. El registro es deberá indicar el motivo del cambio, el antes y el después y la fecha de implementación.

Cualificación del diseño (DQ – Desig Qualification)

The Design qualification It focuses on verifying that the user requirements according to risk analysis should be checked at this stage of qualification, are correct and have been implemented in the design of the facility.

The checks ensure that proposed by the supplier of the installation design meets user requirements and existing standards (GMP, safety). In addition to meeting the operational requirements and the purpose for which it was conceived.

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