Validation of Pharmaceutical Equipment

Design Reviews and Qualification of Facilities and Equipment

PharmOut consultants can help you with the design, design review, selection and installation of the equipment. During this process we will focus on the critical parameters that impact product quality.

Laboratory Equipment Validation

We are experienced in assisting clients with laboratory equipment and method validation.

Risk Assessment

Our Risk Assessment service will:

Identify the risks associated with the process/equipment/materials
Determine the likelihood of the risk
Assess the potential impact of failure

The Risk Assessment results in a matrix document that indicates the level of qualification recommended for the equipment.

This, combined with a Validation Master Plan, defines the systems and equipment to be validated, sets out the number and format of the protocols and establishes the standards for acceptance criteria.

IQ, OQ, PQ

Our Validation Service includes the preparation of :

Installation Qualification (IQ)
Operational Qualification (OQ)
and Performance Qualification (PQ)

We then execute the protocols, analyse and interpret the data collected, resolve any deviations noted during the execution, and prepare final validation reports.

Qualification and Validation are integral steps in Quality by Design, building quality into any process or facility. PharmOut Consulting has years of experience to provide an efficient, effective, documented methodologies to ensure your process efficiencies, quality and compliance global regulations and guidelines.

ISPE Baseline Guide

PharmOut Consulting follows the ISPE Baseline Guide for Qualifications and Commissioning. This ensures Good Manufacturing Practice-compliant documentation.