Active Pharmaceutical Ingredients - QP Module

Newcastle upon Tyne
Monday, 25 June 2018
Active Pharmaceutical Ingredients - QP Module
Monday, 25 June 2018 08:30 -
Friday, 29 June 2018 17:00 (GMT)

Newcastle Marriott Hotel Gosforth Park
High Gosforth Park
Newcastle upon Tyne
United Kingdom

Map and Directions


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 fulfil your responsibilities with competence and confidence.

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
  • Regulatory Environment
  • GMP Guidances/Codes

Manufacturing Site Visits

 The course will include visits to 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.

Course Tutors

  • Mr Mike Halliday
  • Dr Terry Snape
  • Mr Peter Monger
  • Mrs Susan Rocca

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 for more information

The start and finish times given are approximate, please contact our office for further information.


Contact Details

Payment Instructions

  • Payment Methods

    Please note that for customers outside Europe we can only accept credit card payments, we do not accept purchase orders.

    By Bank Transfer 
    — We are happy to accept payment directly into our bank account so long as:

    • a purchase order number is provided (if required my your company)
    • the full amount of the invoice is received net of all local and UK bank charges at least 10 working days prior to the course start date
    • a remittance slip giving clear details of our invoice number is received at this office to coincide with the payment being credited to our bank account

    Our bank details:

    Account No.: 50144499 – Sort Code: 60-16-30

    IBAN: GB38NWBK60163050144499


    By Credit or Debit Card — Using Regonline Secure Payment facility. The total purchase price (including VAT if applicable) and service charge will be displayed prior to confirming the order.

    VAT Invoice — A VAT invoice (if applicable) will be provided (VAT Reg No. GB 927 3679 85).

    Cancellations — Written cancellations with a full refund will be accepted up to 25 working days before the start date of the course. A fee of 50% will be payable for cancellations received between 10 and 25 working days before the start of the course. Full course fees will be charged for cancellations received within 10 working days of the course start date. Delegate substitutions may be made at any time up to the start of the course. Refunds will be made within 30 days of receiving the written cancellation by the same method that payment was made.

    Late Payment Clause

    We understand and will exercise our statutory right to claim interest at 2.5% above the prevailing Bank of England base rate under the Late Payment of Commercial Debts (Interest) Act 1998 if we are not paid according to our agreed credit terms.

    The programme and other information contained on this website are correct at the time of publishing and are published in good faith. We reserve the right to make any changes which may become necessary.

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