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GMP implementation

How GMP implementation made our client stand out in the market

The client aimed to achieve the best GMP standard for spirits production in Europe. Their goal was to differentiate themselves from competitors based on quality assurance, ensuring that customers would choose their products even in the face of slight price differences.

FAT SAT tests

Factory and Site Acceptance Tests

The primary objective of this article is to provide an overview of the comprehensive topic of Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT). It begins by defining the core differences between the tests, moves on to the stages of test planning, defines the participants in FAT tests, etc.

validation of computerized systems

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 pharma

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.

new gmp annex 1

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.

data integrity the word or concept represented by wooden letter tiles

Data integrity – order and security

Modern IT solutions and industry automation are changing the world, and in many areas are contributing to the dynamic development of various sectors, including the pharmaceutical industry.

Changing Project Management Methodology From Traditional to Agile PM

IT Project Management: A Validation Challenge

Computer system validation is a procedure performed in every pharmaceutical or medical device company that uses IT systems at the stage of production, logistics or distribution of its products.