A Q&A paper has been released by EMA that offers some illumination, at least for the time being, on this alternative, performing virtual audits for GMP certification. The goal of both of these “views” is to try to protect human health. Nonetheless, the management mustrigorously evaluate the risk in order to determine if it is necessary to move to virtual audits. You may do so in parallel with the supplier management scheme of each organization or as part of it.
The Pros and Cons for Virtual Audits for GMP certification
While, based on the related risks in this pandemic era, you can affirm the feasibility of remote audits, their practical implementation presents a fascinating challenge for most businesses. This opportunity/challenge also applies to GMP Certification audits. Therefore, based on your background, on-site audits, and the qualifications and abilities of our trained auditors, you can build an open and reliable framework for conducting remote audits. The methodology guarantees that the efforts are often commensurate with the amount of risk associated with the provider or service provider.
Doubts may occur on the following topics tough:
– The security and confidentiality of records,
– Appropriate task setting,
– Unbiased proof standard,
– Software problems and standards
Preparations on both sides for a valuable experience
Despite the ambiguity, if the supplier provides relevant documents in advance to promote the implementation of the virtual audit, the collaborative activities of all partners will result in a detailed and systematic roadmap.
Do not forget to agree in advance on occasional breaks to allow minutes of refreshment for the supervisor and the vendor, which is advised to avoid discomfort from a tightened stance and concentration on the monitors.
The Guidelines for Digital Audits
It is crucial to choose the easiest video chat software from the many options available, which ensures the audit objective and protection because more complexity will lead to more complications. During the audit, the accessibility of video links between the audit respondents can help preserve human interaction, which can be operated very smoothly. In addition, one can also strongly suggest thinking of getting a backup or “Plan B” alternative.
As they were available in electronic format, several parties prefer to display the documents using the screen sharing option. They can provide a simple description of all the protocols in this manner, and the spokesperson practically displayed details.
For this review, the facility tour was not available (perpetuating the usefulness of the remote audit procedures); you can, however, use video images of the facilities, photos, and layouts.
Last but not least,
The dynamic situation created by the COVID-19 pandemic has prompted businesses to change their procedures and practices in all industries. Certainly, on-site investigations of pharmaceutical and biotechnology vendors are not an exception. A plan for virtual audits should be developed by any company. A strategy that will allow supply chains to be kept secure and compatible, even in periods of reduced mobility. In such situations, bear in mind that you need to prove your accuracy.
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