After 20 years in Clinical Quality Assurance I was actually starting to doubt myself.  A few days ago I was requested to provide a proposal for a systems audit of a service provider, but we only had one day in which to do the audit!  I explained to the potential client, that we could conduct an audit in one day, but that they would not receive the level of insight they would find useful from such a superficial audit.  We would need a minimum of two days, and ideally three days to perform a comprehensive audit of a full service provider.  Sadly, we were not asked to submit a proposal.  This was not the first time we had been presented with an unrealistic timeline.  We have turned work away because the restrictions would not have allowed a quality audit to be performed.   Part of the problem is that it is not the Quality Assurance Department that is making these requests, but a separate function focused on managing budgets, without any understanding of Quality Assurance or what is involved in an audit.

I’m not naive; I know there are budget constraints, and audits still have to be completed to avoid an inspection finding!  Am I being cynical in thinking that these restricted audits are purely to tick off that an audit had been done, and supposedly satisfy a regulatory inspector?  Has auditing been reduced to just paying lip-service to the regulatory requirements and expectations?  Have they ceased to be of any value?

When buying a new car, or a new house, or making any significant investment, would we just have a quick look and sign on the dotted line?  How thoroughly would we investigate, to make sure we knew exactly what we were buying?  Shouldn’t the same rules apply to outsourcing key regulatory activities?  The sponsor would be investing not only a great deal of money, but also trust in the service provider.  Shouldn’t they, therefore, properly investigate what they are buying into, rather than saying “yes, do an audit, but don’t spend much time or money on it”?  We often find that a supplier contract is in the process of being finalised (or has already been signed) before the pre-contract audit has been conducted.  Imagine how the auditor is received when they present critical findings to the sponsor! 

Am I being ‘old fashioned’?  Are quick, look-see audits now de rigueur in the pharmaceutical industry?  I don’t think so; at least ADAMAS’s clients still have an expectation of a thorough job!  But I do wonder what is going on in these days of financial restraint, and whether such quick, superficial audits are cost-effective in the long-term?

Caveat emptor!

The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

×
Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

×
How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

×
Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

×
Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

×
ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

×

×