Ermer Quality Consulting
Ermer Quality Consulting, led by Dr. Joachim Ermer, specializes in providing consulting and training in pharmaceutical analysis and Quality Control. With extensive experience in the pharmaceutical industry, the company offers expertise in analytical validation, lifecycle management of analytical procedures, and regulatory compliance. It actively participates in international working groups and develops strategies to support continuous improvement and regulatory flexibility in pharmaceutical analysis.
Industries
Nr. of Employees
small (1-50)
Ermer Quality Consulting
Products
Method Validation in Pharmaceutical Analysis — Guidebook (edited volume)
Edited reference book covering best practices for method validation within the pharmaceutical analytical lifecycle, including method performance characteristics and validation planning.
Quality system for continuous analytical performance verification
Design and implementation of a monitoring system for continuous verification of analytical method performance across APIs, including numerical control parameters and use of control charts.
Method Validation in Pharmaceutical Analysis — Guidebook (edited volume)
Edited reference book covering best practices for method validation within the pharmaceutical analytical lifecycle, including method performance characteristics and validation planning.
Quality system for continuous analytical performance verification
Design and implementation of a monitoring system for continuous verification of analytical method performance across APIs, including numerical control parameters and use of control charts.
Services
Advisory services covering compendial requirements, analytical data integrity, lifecycle management of analytical procedures, OOS/OOT investigations, method verification and transfer, stability studies, reference standard management, and quality system assessment.
Structured training programs and workshops (classroom, online, self-study with follow-up) on pharmacopoeial requirements, lifecycle management, validation, QC laboratory requirements, practical statistics and stability testing; modular and 2-day course formats available.
Advisory services covering compendial requirements, analytical data integrity, lifecycle management of analytical procedures, OOS/OOT investigations, method verification and transfer, stability studies, reference standard management, and quality system assessment.
Structured training programs and workshops (classroom, online, self-study with follow-up) on pharmacopoeial requirements, lifecycle management, validation, QC laboratory requirements, practical statistics and stability testing; modular and 2-day course formats available.
Expertise Areas
- Analytical method validation and verification
- Analytical procedure lifecycle management
- Quality control laboratory requirements and GMP compliance
- Statistical analysis for quality control
Key Technologies
- High-performance liquid chromatography (HPLC)
- Gas chromatography (GC)
- Atomic absorption spectroscopy (AAS)
- Liquid chromatography–mass spectrometry (LC-MS)
News & Updates
On December 20, 2023, the revised ICH validation guideline Q2 and the new Q14 guideline for methods development were published, addressing deficiencies and introducing new requirements.
On December 20, 2023, the revised ICH validation guideline Q2 and the new Q14 guideline for methods development were published, addressing deficiencies and introducing new requirements.