Ongoing Stability Testing

About this course

In June 2006 the EU implemented a change to Chapter 6 of the EU GMP Guide to add the requirement that the stability of marketed products be monitored according to a continuous programme that will detect any stability issues.

ICH Q7 GMP for APIs also requires that “at least one batch per year of API manufactured should be added to the stability monitoring programme and tested annually to confirm stability”.

This pharmaceutical training course is designed to help you understand and meet the EU GMP expectations in an effective and efficient manner that will add value to your business.

You will receive detailed guidance on what is required for a compliant ongoing stability programme and how to analyse the data that is produced.

What You Will Learn

• The requirements of EU GMP Guide Part I, Chapter 6 and Part II (ICH Q7)
• How to analyse stability data on an ongoing basis, tracking trends
• How to put together an effective ongoing stability programme and how to make the process efficient by bracketing pack sizes, product strengths, etc.
• How to handle the issues that arise in ongoing stability, such as missed time points, storage temperature excursions and OOS or OOT results

Course outline

Ongoing Stability Testing

• What is it and why is it important?
• Legal requirements; EU GMP Guide Chapter 6 and Part II (ICH Q7)
• What are the key elements of an ongoing stability programme?

Data analysis techniques for predicting stability and identifying OOT results, based on ICH Q1 guideline

The design of an efficient stability programme

• Bracketing and matrixing

How to handle issues that arise with stability testing

• Sample management
• Qualification of stability chambers
• Missed time points
• Storage temperature excursions
• Investigating OOS/OOT results

Discussion and Working Groups

A significant proportion of the course time will be devoted to group work,where delegates have the opportunity, through case studies, to put theory into practice.

Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.

Best Practice for the Analytical Laboratory

The integrity of analytical laboratory data relies on the knowledge, understanding and training of all the people involved

Over the past 25 years NSF-DBA has built a strong reputation for providing high quality training on numerous aspects of Good Manufacturing Practice.

This course is designed to provide you with our ‘trademark’ practical advice on what to do to achieve cost-effective quality assurance whilst satisfying current regulatory authority expectations.

Venue

Manchester Marriott Victoria and Albert Hotel, Manchester, UK

The Manchester Marriott Victoria & Albert Hotel stands on the banks of the River Irwell, near the city centre but convenient for Manchester Airport (19km), the city’s Piccadilly rail station (3km) and the UK’s motorway networks.

Recently lovingly restored, this Grade II listed building bears many modern features. The hotel has its own car park and a few minutes’ walk takes you to the city’s main shopping and eating district.

Hotel Accommodation

• Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
• To take advantage of this offer, you must book via a special weblink, details of which are provided under the ‘Hotel Bookings’ section at the bottom of this page.
• This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
• If you need any help or guidance with the accommodation booking process, please contact our course administration team.
• Your account with the hotel should be settled at check-out.
• Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.

Venue Address and Contact Details

Manchester Marriott Victoria & Albert Hotel
Water Street
Manchester
M3 4JQ
England

Tel: +44 (0) 161 832 1188
Fax: +44 (0) 161 834 2484

www.marriott.co.uk

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our experts for this course are:

• 

  Mr Peter Gough
  Executive Director
  MSc, CSci, CChem, FRSC, FCQI, CQP

  • [email protected]
  • +44(0)1751 432999

What you've said

“Would have liked even more statistics!”

Sarah McConnell, Ipsen Biopharm, UK

“Well set out, very informative, good feedback with lecturers.”

Andrew Rimmer, Mölnlycke Health Care, UK