QP Module 5: Active Pharmaceutical Ingredients

About this course

The quality of a medicine depends in no small part on the quality of its ingredients, and in particular the active.

Thus, the Qualified Person and other key professionals in dosage form manufacture must have a thorough understanding of how the manufacture and control of the active and its supply chain may influence the fitness for use of the finished product.

This is recognised by the regulators, especially in Europe where the adoption of Directive 2004/27/EC has put the responsibility for assuring the quality of the active firmly on the shoulders of the dosage form manufacturer, with certain expectations specifically for the QP.

This course is designed to provide you with the knowledge and understanding to fulfill your responsibilities with competence and confidence.

Why This Training Will Benefit YOU

The Aspiring Qualified Person

• This series of 12 modules held over a 21 month period has been carefully designed to meet the requirements for theoretical training detailed in the latest UK Qualified Person Study Guide and EC Directives 2001/82/EC and 2001/83/EC.
• All our training courses provide practical, face-to-face tuition in sufficient depth to prepare you fully for the challenges that lie ahead.
• Our training is generally considered as the best available and our QPs are held in high regard within the industry.
• As well as being accepted in the UK, our training courses are well known and accepted by several other EU countries, including Ireland, The Netherlands, Austria, Hungary and Malta.
• You are more likely to become a QP with us than with any other training provider!

The Pharmaceutical Technical Professional

• Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers within other areas of pharmaceutical manufacture and control.
• Increasingly, companies are using these modules as part of a modular technical and professional development plan for their staff.
• Additionally, many industry professionals attend the courses as part of their Continuing Professional Development.
• This course is designed to lead to Postgraduate Certificate, Diploma and MSc qualifications depending on modules taken and work commitment by students. For further details, please contact Stella Pearson-Smith, our QP Course Administrator at [email protected] for more information

Course outline

Active Pharmaceutical Ingredients

• The Regulations
  • EU and US regulations and guidelines
  • Drug Master Files and Certificates of Suitability
  • Key GMP guidance – ICH Q7
• Manufacturing Processes and Quality
  • Key issues for…
    • Synthesis
    • Purification and impurity control
    • Packaging
  • Process Validation
• Supply Issues for the Dosage Form Manufacturer
  • Supplier selection and audit
  • Supply chain integrity
  • Technical Agreements
  • Certificates of Analysis

Bulk Biologicals and Biotech Products

• What is a Biological?
• EU and US Regulatory Aspects
• Essential Characteristics of Biologicals
  • Antibiotics
  • Vaccines
  • Blood products
  • Monoclonal antibodies
  • Recombinant DNA products
• Quality Aspects
  • Control of starting materials
  • Control of cultivation and purification
  • Analytical techniques to judge quality

Excipients

• Regulatory environment
• GMP guidances/codes

Manufacturing Site Visits

The course will include visits to a state-of-the-art API manufacturing facilities in the area in order to put into practical perspective the key issues discussed in the lectures.

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 question and concerns.

Venue

Durham Marriott Hotel Royal County, Durham, UK

Situated on the banks of the River Wear, the Durham Marriott Hotel Royal County offers sensational views of England’s famous Durham Castle and Cathedral. This upscale hotel, part of which dates back to the 17th century, offers modern amenities while preserving historic charm and exquisite features such as antiques and original prints.

Their elegantly furnished guest rooms feature a dedicated workspace, hair dryer, adjustable climate control, and high-speed Internet service. After a long day, swim in their indoor pool, work out in the fitness centre, or have a cocktail or coffee in the Durham Bar. And when you’re ready to dine, discover Durham’s newest Steakhouse in the County Restaurant. At the Durham Marriott, one of the most desirable hotels in north east England, you won’t be disappointed.

Hotel Accommodation

• We have a block booking of bedrooms at the Durham Marriott Royal County Hotel, at a specially negotiated bed and breakfast rate per delegate per night.
• As part of our improvements to the booking process, we have arranged for an online booking service with the hotel and details of how to make your accommodation booking will be included in your course joining instructions (issued to you at the time of booking). Alternatively you will be able to make a telephone booking directly with the hotel. 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.

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 Mike Halliday
  Partner
  BSc (Pharm), MRPharmS, PGDip

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

  Dr Terry Snape
  Consultant
  BA, PhD, CChem, MRSC

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

  Dr Gary Rees
  Consultant
  BPharm, PhD, CChem, MRSC, FCQI, CQP

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

  Mr Peter Monger
  Consultant
  CChem, FRSC

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

What you've said

“It was a very good summary of API expectations. Being an API manufacturer, it was important for me to know the QP expectations. The course fully met my requirements. Thank you!”

Edit Berezvai, Sanofi-Aventis-Chinoin Ltd

“It was very nice to visit an API plant and match the lectures with the real-life situation. The buzz group about planning/content for an audit was very helpful for my further tasks at the company”

Leen van de Water, Pannoc NV

“Course was beneficial in gaining a better understanding of the expectations a QP/Customer would have regarding an API supplier and the areas/systems/standards required, particularly as I am working for an API manufacturer. The course was also beneficial in providing an overview of the regulation of APIs which I personally wouldn’t have much dealings with on a day to day basis”

Evan McCarthy, Novartis Ringaskiddy Ltd