Core Processes in the Pharmaceutical Laboratory: EU GMP-Compliant Sampling and Handling of Substances
Product Details
Complying with good manufacturing practices (GMP) is mandatory for your drug’s success – sampling, testing and packaging materials all need to meet stringent regulatory standards.
Set yourself up for EU success with the purchase of our new management report, Core Processes in the Pharmaceutical Laboratory: EU GMP-Compliant Sampling and Handling of Substances.
Five experts in the implementation of GMP standards in the EU guide you through the planning and execution of materials sampling and testing to ensure your compliance. These steps are the first links in the chain of quality control. Mistakes made during sampling, for instance, will put the wisdom of all subsequent manufacturing steps in question and cannot be eradicated or made up for later.
This management report includes practical and detailed instructions, illustrations, examples, tables and checklists enabling you to quickly familiarize yourself with all of the steps of manufacturing best practices:
- Batch sampling principles and requirements
- Factors influencing sample selection
- Qualifications and training of people doing the sampling
- Special requirements for microbiological sampling
- Risk assessment for sampling
- The two classes of drug substances — reference standards and reagents
Get the report today to help your team get clarification on regulatory requirements, methodological principles and practical recommendations to ensure the quality of your sampling, testing program and finished drug.
Key Report Highlights
- The necessary equipment to ensure a representative sample
- Materials you must sample and what factors you must consider
- Factors influencing the sampling process as part of risk-assessment plans
- Basic rules for ensuring that representative samples are taken
- Documentation requirements
- Proper storage and shipment of samples
- Checking on substances’ suitability and intended use
- Ways to characterize and qualify substances
- Requirements for storage and shelf life
- Questions likely to arise during an audit
About the Experts
Frank Böttcher, CEO of Labor LS SE & Co. KG, is responsible for operations, quality, HR and finance. He is an authorized expert in accordance with the German Drugs Act (AMG § 65.4) and is involved in a number of different working groups that focus on the testing of medicinal products and medical devices. His other areas of expertise include contract agreements in manufacturing and testing as well as the manufacture and testing of sterile products.
Jürgen Eberlein has worked as a qualified person and control sample expert in accordance with the German Drugs Act (AMG § 65.4) in the quality assurance department of Labor LS SE & Co. KG since 2014. He also carries out customer audits and official inspections.
Annette Könemann has been the head of quality at Labor LS SE & Co. KG since 1994, where she is responsible for the organization of the integrated management system and for ensuring compliance with national and international regulations during the testing of medicinal products and medical devices. Ms. Könemann’s tasks include the further development of existing quality standards, such as GMP, cGMP, GLP and ISO 17025. She also carries out supplier and customer audits and prepares and supports official inspections.
Josef Künzle is head of global quality management at Basilea Pharmaceutica International, where he is responsible for all GxP departments. Before joining the company in 2007, he spent the prior 18 years in the pharmaceutical industry in analytical R&D, quality control and quality management, taking part in official inspections and global supplier audits. Mr. Künzle also works as a GMP trainer and shares his expert knowledge at GMP training events.
Markus Limberger is co-founder and CEO of Quasaar, which has been providing GMP consultancy in product development and product control since 2015. His areas of expertise include method transfer, OOX process, qualification of standard substances and reagents, auditing, and increased efficiency in the laboratory. He is a member of the Association for Pharmaceutical Technology (a pharmaceutical expert in the group for quality assurance and analysis) and has been part of the team of authors of Maas & Peither AG– GMP Publishing since 2014.
Who Will Benefit
- Quality Management Staff
- Regulatory Affairs Personnel
- Logistics and Supply Staff
- Packaging and Distribution Department Personnel
- Lab/testing Staff
Add to Cart
Experts:
Frank Böttcher, Jürgen Eberlein, Annette Könemann, Josef Künzle and Markus Limberger
ISBN-13:
978-1-60430-130-4
Publication date:
April 2020
Page count:
52
Multi-user Access
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Books Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Our Guarantee
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.