home > > autumn 2019 > unfamiliar grounds

Unfamiliar Grounds

Audit preparation can seem like a daunting task, especially when the subject area is complex or unfamiliar. It is often a balancing act between competing priorities and expectations, as well as being vigilant that the audit remains a quality assurance exercise (i.e., scratching the subject surface and verifying compliance through information sampling).

Know the Audit Scope

Very rarely are auditors in a position to attend an audit with little preparation. To do so would only set the audit up for disaster as essential audit objectives may not be met, with time spent on activities that were not a priority for the audit outcome.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:

There are no comments in regards to this article.

About the author

Iain Pulley is a GCP auditor with over 12 years of experience auditing both global pharmaceutical organisations and clinical trials. With a BSc (Hons) in Product Design, he is passionately process-orientated and places a strong emphasis on ensuring quality management systems add value to achieve right-first-time results. Iain has also successfully assisted and coached various organisations in preparation for receiving regulatory authority inspections.
Print this page
Send to a friend
Privacy statement
News and Press Releases

Optimizing pharmaceutical processes

An increase in requirements from regulatory agencies around the world, combined with a growing demand for drugs in prefilled injections systems – a trend that industry experts have projected will continue – has led pharmaceutical and biotech supply chains to gain in significance. Well established and optimized processes are crucial for offering uninterrupted market supply. To satisfy its customers a CDMO must foster flexibility, efficiency and safety throughout the entire supply chain. The most important goal for all parties involved in the bio-pharma business is maximization of product quality where even small decisions can make a big difference. Future-oriented pharma processes can add value to any compound.
More info >>

White Papers

Key to Outsourcing Method Development and Validation: A Pragmatic Approach


In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation. As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP). Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
More info >>

Industry Events

World Vaccine Congress Europe

18-21 October 2020, Barcelona, Spain

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>



©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement