How to Perform Effective Product Quality Reviews

About this course

On 1 January 2026 the EU implemented a change to Chapter 1 of the EU GMP Guide to add the requirement to produce a regular Product Quality Review. This listed numerous criteria which should form part of that review.

The FDA has long required product reports to be submitted for licensed products and ICH Q7, GMP for Active Pharmaceutical Ingredients, also requires that “processes should be periodically evaluated to verify that they are still operating in a valid manner”.

This course is designed to assist you and your company in producing Product Quality Reviews which meet these GMP expectations in an efficient manner that will add VALUE to your business as well as compliance to your operations.

What You Will Learn

• The regulatory requirements for medicinal products and Active Pharmaceutical Ingredients in the EU and USA
• The data that should be included in a Product Quality Review and what may be excluded
• Statistical techniques to enable you to analyse and interpret data effectively
• How to decide if a process is in control, capable and still valid
• How to produce Product Quality Review reports which add value to your business and meet all regulatory expectations

Course outline

Periodic Product Reviews

• What they are and why they are important
• Current regulatory expectations:
  • EU GMP Chapter 1
  • US CFR 21
  • ICH Q7
• Data requirements

Data Analysis Techniques

• Pareto charts
• Control charts
• Process capability
• Linear regression

Data Interpretation

• How to identify trends in, and draw conclusions from, data

Product Review Reports

• How to present the information
• How to document conclusions

Acting on the Information

• How to make the exercise add value to your business

Discussion and Working Groups

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

Additionally, discussion periods will provide delegates with an opportunity to have their specific questions answered.

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

Hotel Bookings

If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following this link

This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.

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

What Previous Attendees Said About This Course

“Very useful, lots of food for thought.”

Sylvia McDonald, Pharmapac UK Ltd, UK

“The course was great and met all my objectives and will most certainly help me implement a satisfactory PQR into our quality system.”

Ian Snowball, Fujifilm Diosynth Biotechnologies UK Ltd, UK

“Good course would have been great 3 years ago to avoid lots of pain and capture opportunities.”

Scott Roach, Ipsen Biopharm Ltd, UK

“Course highlighted areas in relation to trending that will benefit our product quality review.”

Steve Couchman, Medimmune UK Ltd, UK

“Good overall standard.”

Marie-Christine Bellens, ALK-Abelló , Denmark

“It was interesting to see how people from other companies manage PQR. Better understanding of what is expected from a PQR. The course gave me tips/quick wins to perform PQR.”

Nicholas Magotteaux, GlaxoSmithKline Biologicals , Belgium

“Help with understanding of importance of statistical analysis in PQRs.”

Tammy Frost, Dermal Laboratories, UK