Are you ready to introduce a new process equipment into a production line with validated cleaning effectiveness? The answers to the following questions will help assess the readiness to introduce new equipment into the pharmaceutical manufacturing area and identify the scope of GMP-related activities required in this process: The answers
The following article outlines the key changes introduced in Polish legislation regarding the amendment of the Regulation of the Minister of Health of 9 November 2015 on the requirements of Good Manufacturing Practice (GMP), updated by the latest amendment of 4 December 2024 (Journal of Laws 2024, item 1816). It
The implementation of a GMP (Good Manufacturing Practice) System is a challenging, labor-intensive, costly, and ambitious milestone in the company’s development. The need to implement and certify a GMP system applies to companies manufacturing medicinal products at any stage (it could be the full manufacturing process with controls up to
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.
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.
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.
