Zamann Pharma Support logo

Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Request an appointment now

Innovations and highlights in the Pharma industry 

Dive deep into the world of Pharma with Zamann’s Expert Blog. Our industry-leading professionals share insights on global project management, quality consultancy, digitalization, and more. Stay updated with trends and innovations transforming the Pharma industry. 

News and more

CSV to CSA: From Compliance to Confidence

Enhance efficiency and compatibility by transitioning from CSV to CSA, ensuring seamless integration across platforms and systems for improved performance and streamlined operations.
  • Computerized System Validation
Emergence of CSA for streamlining compliance in the digital era.

FDA 21 CFR Part 211 and Understanding its Requirements

21 CFR 211 compliance is your organization's stepping stone to meeting the FDA's definition of current good manufacturing practice (cGMP). Complying with 21 CFR 211 proves that your business has a safe, effective, consistent and quality-managed drug manufacturing operation in
  • Quality Management System

EU Annex 11 and its comparison with FDA 21 CFR Part 11

Unlock the secrets of regulatory compliance comparison of EU Annex11 and 21CFR Part 11! These guidelines differ in scope and requirements, ensuring your computerized systems meet the highest standards in pharmaceutical and life sciences.
  • Computerized System Validation, eQMS

ISO 13485:2016 Guide for Medical Device Manufacturers

ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for manufacturers of medical devices. The standard aims to ensure the safety and effectiveness of medical devices by introducing a risk-based approach to quality management.
  • ISO 13485, Medical Devices

How to prepare for GMP Inspection in 5 steps

Prepare for a successful GMP inspection by conducting internal audits, implementing strong quality control systems, staying updated on regulations, utilizing technology, and conducting mock inspections. These steps will help pharmaceutical companies ensure compliance, uphold quality, and demonstrate commitment to patient
  • Audit and Inspection, Quality Management System
GMP Inspection

IQ, OQ, PQ: Essential Steps for Equipment Qualification

Equipment quality in pharmaceutical manufacturing is ensured through IQ, OQ, and PQ phases, validating installation, performance, and user needs. Regulatory mandates prevent hazards, like mislabeling, with ongoing compliance via requalification. Expert guidance streamlines validation efforts for robust, compliant systems.
  • Equipment Qualification, Validation and Qualification

Peering into the Future: What’s Next for Medical Device QA?

The landscape of medical technology is evolving at a rapid pace, and medical device quality assurance (QA) needs to evolve alongside it. Traditional methods are reaching their limits, and innovative technologies are stepping onto the stage.
  • Medical Devices

What is GAMP 5 Guideline? Checklist for GAMP 5 compliance

GAMP is the acronym used to summarize the term “Good Automated Manufacturing Practices“. These are a compilation of recommendations published by the International Society for Pharmaceutical Engineering (ISPE) in the form of a book to provide guidance on the compliance
  • Computerized System Validation, GAMP 5