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Category: Blog

Aseptic Manufacturing

The Role of Isolators and RABS in Aseptic Manufacturing

As the pharmaceutical industry continues to evolve, aseptic processing must keep pace with advancing technologies. The choice between Open RABS, Closed RABS, and Isolators is crucial in ensuring sterility, regulatory compliance, and cost-effectiveness in injectable manufacturing.

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Female pharmacist staring at packaged pharmaceutical drugs in her hands
Blog

How to predict for the formation of NDSRIs ?

The detection of N-nitrosamine impurities in medicines and the increasing presence of nitrosamine drug substance-related impurities (NDSRIs) have presented significant challenges for both drug manufacturers and regulatory agencies.

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Pharmacy, shopping and man reading medicine box, customer supplements product or drugs store pharma
Audit and Inspection

Guide to FDA Drug Product Recalls Avoidance

FDA drug recalls play a critical role in protecting public health by ensuring that unsafe or defective products are removed from the market. Staying ahead of compliance challengesFDA recalls are costly, but proactive compliance measures can significantly reduce the risks.

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Blog

Getting Started with Process Validation

Learn the fundamental steps and best practices for successful Process Validation in manufacturing, covering design, qualification, and continuous monitoring to ensure product quality and compliance.

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Blog

The Evolution of Quality Assurance in Pharma: A Journey Through Time

Explore the transformative journey of quality assurance in the pharmaceutical industry. From early manual inspections to today’s cutting-edge AI-driven quality control, this article delves into the pivotal moments and technological advancements that have shaped pharma QA, highlighting the commitment to patient safety and innovation.

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Blog

Medication rather than COVID vaccine – What are the options?

Vaccinations against the SARS-CoV-2 virus are in full swing in all countries. Many people hope for more normality and a way back to old life. So we know that vaccination is the right way, but not everyone is open for this solution. What if a drug treatment of coronavirus disease would also work? We raise the question here and thus

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Blog

The Golden Ticket to correct results

In the course of the last year a multitude of COVID tests have been developed or are in the process of being developed.  But, it is the PCR test, for the detection of SARS-CoV-2, that has been the central talking point. The classic PCR test was developed in the 1980s and was a major milestone in laboratory diagnostics. It is

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Blog

Quality – More than a seal of approval

Let’s start by asking the question: What is quality? In simplified terms, quality is the sum and/or the quality of all properties of an object, system or process. The international standard for quality management systems DIN EN ISO 9000 goes a step further and describes quality as: “The capability of a totality of inherent characteristics of a product, a system

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Blog

From the MDD to the MDR – Navigating the Transitory Period

In 2017, the European Union (EU) instituted the Medical Device Regulation (MDR) as the next phase in the medical device regulatory framework in order to replace the current Medical Device Directive (MDD). The MDD has been in effect since 1993, and was devised in order to harmonize disparate laws, regulations and requirements pertaining to medical devices. Devices which conform to

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