Edition 3 / September 2020
As a leading CDMO, the evaluation of CordenPharma facilities and people is business critical for providing confidence with contracted activities to our customers. The intention is to ensure the facility and staff are adequately controlling manufacturing operations, and to assure an outcome of patient safety and quality medicines.
Onsite interactions are mandatory elements of customer oversight. Conducting this activity remotely offsite – in the same exact manner as onsite – is arduous for the working relationship between auditor & auditee. Misunderstandings will and do arise because of the change in working environment. The virtual conferencing options, camera equipment, time allocated to the audit, and physical environment for both auditor & auditee are diverse and complex aspects to the performance of the working relationship.
CordenPharma seeks to optimize performance through the systematic application of best practices, now integrated within the framework of audit and inspection management. The lessons we learned over the past few months center around the fact that the training, experience and education we are accustomed to for in-person audits are not instantly transferable to remote auditing. Constant reflection and discussion are needed between auditor & auditee about the dynamics of remote interpersonal interaction, and handling of data shared electronically. Our learning to place an absolute focus on the human overcomes limitations stemming from the lack of in-person discussion. This new ‘remote workspace’ culture is allowing innovation.
With travel & health restrictions, employees of customers, regulators & CDMOS are looking for equivalency in evaluating remote or virtual alternatives. While companies and regulators initially deferred field visits during the first period of the outbreak, a global realisation now exists that we need to work in an altogether different way for some time to come.
CordenPharma has successfully facilitated three regulatory and five customer virtual audits in the past six months. Our main takeaway is to remain focused on the changing human interactions, and not solely on providing technical or software tool alternatives to in-person interaction. That is not to say digitalisation isn’t enabling success – it is – but we recommend placing more emphasis on the human element.
Auditors and auditees will experience emotional ups and downs as they work together remotely. Our experience shows that bringing more awareness of this to both parties plays an important role in minimising adverse interaction. Also, since body language on camera is not the same as in-person, and audio quality can affect tone of voice, transparency and trust may be affected by misconceptions about the scope of the audit.
We have seen initial hesitancy from some auditors to provide a list of topics to the facility to prepare in advance of the scheduled audit date. Auditors naturally want to have flexibility and the ‘element of surprise’ to move between quality systems and product topics at their discretion. While more possible with in-person audits, remote assessments require more formalised work upfront from both sides to fine-tune the focus. We recommend using quality risk management to ensure an efficient process, along with multiple communications by video directly with the auditor to address misconceptions, test internet connections, and address potential concerns in following this proposed new approach.
Some customers outsource to third party companies to perform their audits. Third parties also provide GMP consulting services and maintain large knowledge management databases of SOPs, layouts etc. to do their other business. We have in some cases received requests to send third parties large numbers of IP files. There is a natural hesitancy to do so.
Although a third party auditor request is very understandable, the auditor, having never visited the facility nor being an employee of the customer, has no prior product knowledge, so wants to prepare as much as possible before the video call. What we are doing now, is to help the third party auditor prepare in advance whilst maintaining our own internal policies with regards confidential documents not leaving our control.
In efforts to secure and protect IP (for example how to prevent screenshots on secure PDFs), we noted the publishing world solved this problem years ago with the move from paper to online e-books. Intellectual assets and patents are the outcome of significant efforts and investments at manufacturing facilities, so we think this is an area where more work is required. An opportunity exists for industry suppliers of GMP electronic document management systems to provide solutions for publishing and sharing proprietary content externally.
CordenPharma values its employees, and particularly in these pandemic times, aims to ensure they can take care of themselves and loved ones. For audits, this means that the site SMEs may not be required to assemble at a work conference room when interacting with the auditor. But while remote audit interactions have their benefits, home-based camera placement, lighting, audio quality, and virtual backgrounds can distract both parties, potentially leading to auditor/ auditee frustration and misunderstanding. We mitigate these inevitable scenarios by pre-testing and practicing interactions with the home-based employee beforehand.
CordenPharma are participating with the Parenteral Drug Association’s (PDA) remote inspection / audit workgroup to strengthen global efforts to support virtual oversight, while the COVID-19 crisis is with us. The open and transparent dialogue they are facilitating reflects the topic interest and solution-orientated focus by participant companies. CordenPharma believes that virtual solutions will not and should not replace the valuable in-person interactions at a manufacturing facility for both parties. We are excited by the opportunity to innovate in the remote inspection / audit space – while maintaining the focus on the health & safety of the human element above all.
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