Zamann Pharma Support

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Lampertheim
Zamann Pharma Support

We from Zamann Pharma Support GmbH offer highest quality,
experience & consulting in the pharmaceutical area.

We are validation and support specialists of GxP processes and we provide comprehensive support for pharmaceutical companies.

11/06/2026

Staying compliant with Good Manufacturing Practices (GMP) is essential for every pharmaceutical company – but turning regulations into everyday practice is not always straightforward.

We’ve created a practical pharma compliance checklist that walks through key GMP requirements, helping you:
• Review your quality systems
• Close documentation gaps
• Strengthen training and data integrity
• Prepare more confidently for inspections

Take a look at the full article and see how your GMP processes measure up:
https://zamann-pharma.com/2026/04/07/good-manufacturing-practices-requirements-in-year-pharma-compliance-checklist/

09/06/2026

FDA’s evolving nitrosamine guidance is raising the bar for risk assessment, control strategies, and regulatory expectations across the pharma industry.

Our latest blog explains what the new limits mean in practice, how they connect to ICH M7 and EMA guidance, and the concrete steps companies should take now to be inspection‑ready for the 2026/2027 timelines. We also look at the real role of AI and advanced analytics in nitrosamine identification and control.

If you’re involved in CMC, QA/QC, regulatory, or manufacturing, this is essential reading for keeping your nitrosamine strategy current and compliant.

Dive into the full article: https://zamann-pharma.com/2026/03/30/nitrosamine-fda-guidance-in-year-limits-and-compliance-strategy/

04/06/2026

Disruptions, stricter regulations, and growing complexity are redefining the pharmaceutical supply chain.

Our new article looks at how pharma companies can combine strong governance, end-to-end GxP compliance, and real resilience to keep products safe, available, and compliant — from manufacturer to patient.

If you work in pharma supply chain, quality, or regulatory, this is a practical overview of what needs to change and where to start.

Read the full article here:
https://zamann-pharma.com/2026/03/12/supply-chain-in-pharma-industry-governance-compliance-and-resilience-in-year/

02/06/2026

Are you confident that your Validation Master Plan (VMP) would stand up to an inspection today?

Our new blog post explains what inspectors expect to see in a modern VMP, which gaps they frequently uncover, and how you can prepare your documentation so it is clear, consistent, and fully aligned with your quality system.

If you work in pharma, biotech, or medical devices and deal with validation, quality, or CSV, this article will help you benchmark your current VMP and prioritize improvements.

Dive into the full article here: https://zamann-pharma.com/2026/03/02/validation-master-plan-vmp-inspection-expectations-in-year/

28/05/2026

Signal detection is at the heart of pharmacovigilance – and a frequent focus in health authority inspections.

Our latest blog looks at what inspectors are currently finding in signal detection systems: gaps in processes and documentation, unclear responsibilities, insufficient methods, and weaknesses in follow-up and CAPA.

We also share practical recommendations to help Marketing Authorisation Holders make their signal detection activities more robust, transparent, and inspection-ready.

Explore the full article here and see how your system compares:
https://zamann-pharma.com/2026/02/20/signal-detection-in-pharmacovigilance-in-year-inspection-findings/

26/05/2026

How do you reliably define shelf life under today’s GMP and ICH expectations?

Our latest article walks through key principles of stability testing in a GMP environment – from designing your stability program to interpreting real-time and accelerated data, and managing OOS/OOT results.

If you work in QA/QC, regulatory, or product development, this guide will help you strengthen your stability strategy and stay inspection-ready.

Read the full article here: https://zamann-pharma.com/2026/02/19/shelf-life-determination-in-year-gmp-stability-focus/

21/05/2026

Why are Good Manufacturing Practices (GMP) so strict today?

Because they were shaped step by step by real incidents, regulatory findings, and years of intense inspection pressure.

Our latest blog post walks through the history of GMP – from early quality failures to the modern standards that pharma companies work with today. If you work in quality, production, or regulatory affairs, this background helps explain why auditors focus on certain topics and how GMP expectations keep evolving.

Read the full article here:
https://zamann-pharma.com/2026/02/18/good-manufacturing-practices-history-in-year-how-gmp-evolved-under-inspection-pressure/

19/05/2026

GMP inspections are putting more and more emphasis on your vendors and supply chain.

We’ve put together a clear, practical Vendor Audit Checklist that helps you focus on the areas inspectors care about most – from quality systems and documentation to data integrity, supply reliability and risk management.

If you work in QA, supply chain or regulatory compliance, this guide can support your next vendor audit and help you stay inspection-ready.

Read the full article and download the checklist here:
https://zamann-pharma.com/2026/02/17/vendor-audit-checklist-in-year-gmp-inspection-focus/

14/05/2026

GMP inspections are putting pharmaceutical documentation under even closer scrutiny.

Our latest blog post explains what inspectors are focusing on now – from data integrity and ALCOA+ to consistent procedures, training records and the smart use of digital tools.

If you want to identify weak spots in your documentation and strengthen your quality system before the next inspection, this article is for you.

Read it here: https://zamann-pharma.com/2026/02/16/pharmaceutical-documentation-in-year-gmp-inspection-focus/

12/05/2026

Adverse drug reactions (ADRs) are more than just a line item in a safety report – they are a critical part of how we protect patients throughout a medicine’s lifecycle.

Our new blog post walks you through how ADRs are identified, evaluated and managed from early clinical trials all the way to post-marketing surveillance, and why an integrated pharmacovigilance approach matters.

Get the full story and see how each stage of the pharmacovigilance lifecycle connects:
https://zamann-pharma.com/2026/02/13/adverse-drug-reactions-explained-across-the-pharmacovigilance-lifecycle-in-year/

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