EN PL

Remote Audit

Remote Audits have changed from a slightly futuristic tool into something perfectly suited for present times. Importers and contract manufacturers maintain constant supply chain and may therefore continue their business activities without holding times. On-line audit allows for no delay in the project.

Remote audits for pharma industry – don’t let the pandemic stop you!

Remote audits

Due to the Covid-19, on-site audits of GxP systems have become difficult or even impossible. This became a huge challenge for importers or manufacturers of the medicinal products, for whom maintaining a steady supply chain is a must. With all the travel restrictions in-place and safety concerns Remote Audits emerged as necessary and viable alternative with following advantages:

  • equally valid as on-site audits for QP declaration and honored by key agencies (e.g. EMA).
  • cost effective and safe for both sides (the audited place and the auditor).
  • help avoiding delays and allow maintenance of constant supply chain.
  • allow maintenance of the quality of API and drug manufacturing in the Covid-19 times.

Remote audit is based on a well prepared risk-assessment, followed by means of video conference tools that all allow for independent and objective evaluation of a manufacturer. Typically, before a start of the remote audit, the client is asked to provide the Site Master File document. Based on the provided document an audit is planned and the exact scope of the audit is prepared. The scope includes selection of places that the auditor(s) are going to visit virtually. Before the audit, mock tests are carried out to avoid technical difficulties on the day of the audit. Audit is performed in real time.

The world is changing, go ahead with SciencePharma

SciencePharma has all the appropriate software tools and experience to enable virtual auditing. Since the beginning of the pandemic, we have performed over a dozen of Remote Audits allowing companies to continue their manufacturing activities with no obstacles, in compliance with GMP requirements.

RMP

Our experience, extensive regulatory knowledge and know-how, may be very helpful if you find yourself in the need to have such audit performed.

On-line audits assess meeting GxP requirements, a requirement needed for maintaining constant supply. If you want to sustain a flawless business and have an audit performed, SciencePharma can help you go through it. To find out more about Remote Audits, check our website or contact us directly.

More information about the services we provide and our experience can be found here.

If you are interested in cooperation, please contact us. Our experts will be happy to answer all your questions.
 

CONTACT US