Supplier audit in the implementation of computerized systems
Before selecting a computerized system supplier, the user should evaluate the parameters of the system proposed by the provider and its ability to ensure quality.
Validation of Computerized Systems in a Pharmaceutical Wholesaler
Pharmaceutical wholesalers rely more and more on advanced IT systems for the storage, management and distribution of medicinal products. The introduction of information technology in the pharmaceutical industry has brought many benefits, but at the same time imposes responsibility for ensuring the security, effectiveness and compliance with regulations of these systems.
Process Validation in a Pharmaceutical Wholesaler
Pharmaceutical supply chains are inextricably linked to Good Distribution Practices, Good Manufacturing Practices, and the Code of Federal Regulation; these regulations and guidelines ensure that pharmaceutical products are distributed according to appropriate standards and with safety. One of the key elements of ensuring safety and quality in pharmaceutical wholesalers is process validation.
Revised Annex 1, EudraLex Volume 4
Annex 1, “Manufacture of sterile medicinal products,” is part of EudraLex Volume 4, which provides guidance on the minimum control measures required to protect sterile medicinal products during manufacture. All manufacturers supplying medicinal products to the European market must comply with these requirements to minimize the risk of microbiological, particulate and pyrogenic contamination of the final product.
eCValidation at Pharmap 2023 Conference in Switzerland!
On June 12th to 13th we had the pleasure of participating at the prestigious Pharmap 2023 Conference in beautiful Geneva, Switzerland!
The legal approach to the use of medicinal marijuana in the pharmaceutical industry in Poland.
Medicinal marijuana is a controversial topic. People without awareness often perceive medicinal marijuana as a dangerous, addictive drug used illegally.
ECVALIDATION at the 13th Pharmaceutical Industry World Congress in Warsaw!
The Congress of the Pharmaceutical Industry World is certainly an event not to be missed in the calendar of pharmaceutical and dietary supplement manufacturers, suppliers of raw materials, laboratory equipment, packaging, and solutions used in the pharmaceutical industry. The topics of this year’s edition revolved around trends and directions in the modern pharmaceutical industry. One …
ECVALIDATION at the 13th Pharmaceutical Industry World Congress in Warsaw! Read More »
ECVALIDATION as a sponsor of the XVIII Autumn Symposium of the Pharmaceutical and Cosmetics Industry in Gdynia 17-19 October 2022!
It seems to be a tradition that we are present at the BMP Pharmaceutical and Cosmetics Industry Symposium. We could not miss this time in Gdynia either! The theme of this year’s conference was change, i.e. the direction that companies from both sectors should follow to survive in the market and grow sustainably. As a …
CSV Workshops in Poznań
The penultimate edition of this year’s CSV workshops is behind us! On Friday, we visited Poznań, where, in the surroundings of the charming Old Town, our expert, Michał Timler, introduced the subject of validation of CSV computer systems. Thank you for your attendance and the very positive feedback from the participants. We look forward to …
How to do business under MDR? A 12-step guide to preparing your company for the new regulations
The requirements brought in by the Medical Device Regulation have posed a serious challenge for many companies operating in the medical device industry. Adapting to the new legal reality requires a significant amount of time and effort. We have prepared a short guide for the transition process based on the EU recommendations to give you a clearer view of the situation.