Remote GMP audits (on-line audits)
Remote GMP audits for pharma – still useful on-line tool!
Last years have brought new challenges for the pharmaceutical industry. A number of restrictions introduced, including travel restrictions and safety reasons, made a traditional Good Manufacturing Practice (GMP) audits almost impossible to carry out. In view of such a high risk for the continuity of supply chain of imported pharmaceutical products and without possibility to conduct on-site audit, it was proposed to perform on-line audits. Today, Health-Med recognizes it as convenient and verified solution with a number of benefits:
- Alternative to on-site GMP audits - Confirmation of the quality of pharmaceutical products manufacture,
- Ensuring the supply chain continuity of imported pharmaceutical products,
- Qualified Person declarations (QP declarations) issued on their basis are acceptable by Agencies, including the European Medicines Agency (EMA),
- Cost-effectiveness and speed - elimination of the travel factor and various types of delays, which in consequence do not disturb the availability of pharmaceutical products,
- Safety of both parties - audited and auditors.
Conducting an effective and objective remote assessment of the audited place is possible thanks to the following steps:
- Prepared risk analysis,
- Video-conferencing tools,
- Availability of quality assurance system documents including Site Master File (SMF), instructions and Standard Operating Procedures (SOPs) shared by Client,
- Preparation of an appropriate audit plan including information on the places that the auditors will want to visit virtually.
The audit is carried out in real time, but in order to eliminate technical problems in the process, a mock test is carried out beforehand. Audit is finished by appropriate report preparation.
Remote audit services for API and drug product manufacturer, QC sites, warehouses
Health-Med has extensive experience in auditing manufacturing sites for both active pharmaceutical ingredient (API) and the drug product, as well as quality control sites (QC sites) and warehouses. This experience allowed for the effective development of a scheme for conducting on-line audits.
At Health-Med, remote audits are carried out in accordance with the following scheme.
Currently, after more than 2 years of on-line auditing experience and 20 remote GMP audits we can definitely say that we have all the necessary tools to conduct on-line audits. We have technical service tools and, most importantly, a team of widely experienced experts.
Top quality of GMP audit service due to experience as drug product importer and manufacturer
Are you considering a remote audit? You can count on Health-Med and our extensive experience! As an importer and manufacturer, we perfectly understand our Customers' problems. Our extensive practical experience and professionalism in auditing various manufacturing sites, including API and different pharmaceutical forms of medicinal products, as well as individual approach to each audit are especially appreciated by our Clients.
Remote audit as the new standard for a convenient, cost and time-saving GMP audit
Recent years have shown that epidemic factors, international tensions and the accompanying economic crisis, and the rise in ticket prices largely hinder free communication to distant audit locations. In this realities, remote GMP audits are often a convenient solution which, as it seems, will remain with us in the future as a powerful audit tool at times when on-site audit will be impossible to perform. Lack of barriers in terms of time and location of the auditing entity at the time of assessing compliance with GMP requirements, ensure no delays and continuity of Customer deliveries.
If you are considering a remote audit but you do not feel confident of this type of auditing, Health-Med can help you with it.
Contact us for detailed information.