Subject Matter Experts (SME) | Getting the best from your Experts

Subject Matter Experts (SME) | Getting the best from your Experts

The therapeutics goods industry is stuffed to the gunnels with very smart people; those who know the inside and out of all the processes and procedures in their field. They are the people that you want on board to ensure a thorough and educated approach to document writing and are commonly referred to as Subject…

We have a Pharmaceutical Quality System, why do we then need a Quality Culture?
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We have a Pharmaceutical Quality System, why do we then need a Quality Culture?

Once the Pharmaceutical Quality System (PQS) (as per ICHQ10: Pharmaceutical Quality System) is implemented, it must be ensured that it continues to be effective, and for this to happen there has to be a clear commitment from senior management to a Quality Culture. There are several ways senior management can demonstrate their commitment to the…

Continuous Improvement – An integral part of the Pharmaceutical Quality System (PQS)
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Continuous Improvement – An integral part of the Pharmaceutical Quality System (PQS)

‘Continuous Improvement’ or ‘Continual Improvement’ within a quality system can be described as a process of ongoing improvement of products, services or processes through incremental and/or breakthrough improvements. Within the Pharmaceutical Industry, it’s important that companies ask themselves how continuous improvement has been built into the Pharmaceutical Quality System (PQS). The term may appear in…

Technical writing is a science, not an art
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Technical writing is a science, not an art

Technical writing, in the context of the therapeutic goods industry, applies to those documents which instruct, define or report on regulated manufacturing activities; that is Standard Operating Procedures, forms, validation reports, and Design History Files, to name so very few and which are also referred to as “controlled documents”. So that these documents can be…