Who this product is for
Who this guide is for
This guide is intended for professionals involved in microbiological quality control of non-sterile pharmaceutical products, including:
- QC microbiologists
- QC laboratory personnel
- laboratory managers
- Quality Assurance professionals
- method validation / verification personnel
- contract testing laboratories
- pharmaceutical manufacturers
- professionals responsible for pharmacopoeial method implementation
Practical scope
What the guide covers
- When method suitability is required and what it demonstrates
- Who is responsible for demonstrating suitability
- Regulatory and pharmacopoeial framework
- Method-suitability approaches and practical techniques
- sample preparation
- dilution
- neutralisation
- pour-plate methods
- membrane filtration
- TAMC
- TYMC
- specified microorganisms
- positive controls
- product controls
- negative controls
- inoculum controls
- recovery assessment
- Acceptance criteria and interpretation of results
- Practical examples and case studies
- Common errors and how to avoid them
What you receive
What you will receive
A structured technical guide designed for practical use in pharmaceutical microbiology.
The final publication will combine:
- current pharmacopoeial requirements;
- official regulatory and EDQM guidance where applicable;
- scientific background needed to understand method suitability;
- practical laboratory approaches;
- worked, anonymised examples;
- interpretation of acceptance criteria;
- common implementation errors and practical considerations;
Technical & access requirements
What you need to use this Technical Guide
- A Q-VALIS customer account with a valid email address.
- A desktop computer, laptop, tablet or smartphone capable of opening PDF files.
- A current operating system and a modern web browser.
- JavaScript and cookies enabled for access to your Q-VALIS account and purchase/download functionality.
- A reliable internet connection to access your account, complete the purchase and download the guide.
- PDF reader software or a browser with built-in PDF support.
- Sufficient local storage space to save the downloaded PDF.
- English-language reading proficiency, as the Technical Guide is provided in English.
- Access to the internet is required for purchase and download. After download, the PDF may be used offline on a compatible device.
Access / delivery conditions
Download and use
Downloadable PDF after purchase.
The guide is in preparation. Purchase and download are not yet available.
Customer information
Legal and support information
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