Validating pharmaceutical

17-May-2019 12:13

The HGP consultants will support you here not only as experts in Gx P compliance and validation but also from the commercial aspect of cost efficiency. CSV strategy A good CSV strategy is tailored to your processes, your organisation and IT and automation landscape.

This is what you can achieve: CSV Audit We audit using a standardised method, taking international requirements into account. For example, an audit for preparing an official inspection can therefore be carried out, (e.g. We start by identifying the current situation with the help of a standardised method, e.g.

Essential Sections of Any Validation Plan Instrument validation begins with a validation master plan that defines the steps in each process.

Traditionally, these steps can be categorized into 5 separate qualification categories (DQ IQ OQ PQ CQ), which include: Creating a Calibration process that encompasses all the requirements can be time-consuming and cumbersome.

Our cleaning validation analytical programs include method development (or method transfer) and method validation where we focus on the critical aspects of LOD, LOQ, precision, linearity, selectivity, recovery-spiking, consistency of recovery.

With many years of experience in partnering with manufacturers around the world, we are able to develop highly specific methods for the more common residues, but also for the more complex, such as reaction by-products and degradation species.

Such skills are especially important with computer systems validation (CSV; see COMPUTER VALIDATION sidebar below).

Validation services can help you save both time and money by streamlining your validation procedures.

Validation of computerised systems according to Gx P Guidelines (CSV) has been a basic requirement in the healthcare industry for many years.

To address the need for ongoing training in validation, many scientific and engineering professional associations, such as ISPE, have developed programs designed to ensure competence in key areas of practice.

Within Puerto Rico, industry leaders have gone one step further, by establishing a “Validation Academy” within the Polytechnic University of Puerto Rico’s Continuing Education Department.

Such skills are especially important with computer systems validation (CSV; see COMPUTER VALIDATION sidebar below).Validation services can help you save both time and money by streamlining your validation procedures.Validation of computerised systems according to Gx P Guidelines (CSV) has been a basic requirement in the healthcare industry for many years.To address the need for ongoing training in validation, many scientific and engineering professional associations, such as ISPE, have developed programs designed to ensure competence in key areas of practice.Within Puerto Rico, industry leaders have gone one step further, by establishing a “Validation Academy” within the Polytechnic University of Puerto Rico’s Continuing Education Department.Regulatory agencies around the world have strict requirements for quality, procedures, performance testing, safety checks and the like, for a wide range of products.