The cinephiles out there may have recognized the reference in the lead to the Stanley Kubrick classic “Dr. Strangelove”. One of the best satirical films ever made guide us through the tensions of the cold war and the attempts of the politicians in the War Room to avoid Armageddon.

The movie’s terrifying background is used to portrait a scenery of chaos based on lack of control, misinformation, miscommunication and different characters involved pursuing different objectives.  

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And that’s our starting point for this reflection. Besides globalization many advantages, there is a big constraint associated with it for pharmaceutical companies worldwide, the increased complexity of their supply chains.

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This fact introduces communication difficulties and a constant lack of control and overview of our suppliers, from the critical ones to the ones that do not impact on the quality of our product.  

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Auditing may be a key tool to overcome these difficulties, if properly used. However, due to financial restrictions and increased number of audits to be executed, the temptation and the pressure for the companies to choose standardized low-cost audits is enormous.  

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These audits may suffice in complying with the regulations, however, they may fail in adding extra value to the audit exercise and to the company itself. On the other hand, customized audits may use the time on the audit day for establishing proper channels of communication, to look into specific concerns about the supplier processes and products, to identify trends and to improve the relationship with the supplier and the overview of their processes.

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It is also important to mention that increased concerns of the regulatory authorities have arisen regarding this lack of control through the recent update of EMA Questions and answers (namely, questions 3 and 9 under EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substance). This specific update demonstrates the concerns of the authorities in the independence and robustness of audits executed by third party companies.  

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Further requirements to introduce controls through effective audits have been identified in the new revision of GACP (Good Agricultural and Collection Practices) and in the draft revision of the Annex 11 of Eudralex Vol. 4, to have periodic audits for the cultivation and/or collection sites and to vendors and service providers of computerized systems, respectively. All of these may give us hints on how the authorities are approaching the importance of the audit and the way they are carried out.

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At Owlpharma, this topic is being taken very seriously because in fact it aligns with one of our core principles. As a consultancy company, we have never settled in doing things in a satisfactory manner, we’ve always put our hard work in bringing meaning to our services and in executing services that really represent an added value to our clients’ organization.  Therefore, we have added robustness to our statements of conflict of interest and to our documentation to be even more trustworthy for our clients.

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