The Road to a Pharmaceutical Quality System in the EU

Is your pharmaceutical quality management system (PQS) designed to meet it’s primary objective — patient safety?

The Road to a Pharmaceutical Quality System in the EU walks you step-by-step through the processes and procedures you must put in place to comply with the EU’s good manufacturing practices (GMP) requirements. It enables you to build an effective PQS so you stay compliant with GMP.

In this report, international quality management and auditing expert Stephanie Blum explains the EU’s PQS requirements — including ISO standards and ICH guidelines. She provides direction on how to build a system that will keep your manufacturing operations compliant and in a state of control.

Key Report Highlights:

• Basic principles and elements of a PQS, including
  • Change management
  • Corrective and preventive action
  • Complaint management
  • Supplier qualification
• Resources needed to establish a quality system
• Quality policy and planning, including compliance with ICH Q10
• Essential quality system documentation, including
  • SOPs
  • Protocols for validation, training and analysis
• Requirements for original records and reports
• How to develop a quality manual
• Management review in accordance with ISO 9001, including
  • Defining key performance indicators
  • Frequency and reporting of review findings

Discover how to look beyond the multiple silos that so easily develop around individual drugmaking activities. The Road to a Pharmaceutical Quality System in the EU will show you how to implement new problem-solving approaches at every level of your manufacturing process. Order your copy today.

About the Contributor

Stephanie Blum is the owner and CEO of the cirQum consultancy in Frankfurt, which she founded in 2008. A molecular biologist, she previously worked for 10 years in the biotechnological and pharmaceutical industry at the managerial level. Ms. Blum works as an auditor, consultant and speaker and is the author of various expert publications.

cirQum is a service provider in the area of pharmaceutical quality management — good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP), good clinical laboratory practice (GCLP), good documentation practice (GDP), good agricultural and collection practice (GACP) — with a focus on outsourced audits, quality management consulting and training. The company’s focus is primarily on the GMP audits of contract manufacturers and contract laboratories, including manufacturers of active ingredients, excipients and packaging materials. Furthermore, cirQum carries out GACP audits of the growers and suppliers of vegetable raw materials for manufacturers of herbal medicinal products. The company also specializes in GDP audits of haulers, warehouses and wholesalers; and GCP, GCLP and GLP audits of test centers, laboratories and testing facilities. It offers training courses and seminars on GXP issues as well as pharmaceutical quality management consultancy.

Who Will Benefit