About This Course

Pharmaceutical Formulation and Processing – Part 1

This intensive, interactive four-and-a-half-day pharmaceutical formulation and processing training course is designed to allow aspiring Qualified Persons and other pharmaceutical technology professionals to understand the key quality requirements of non-sterile dosage forms such as tablets, capsules, liquids, topical medicines and inhalation products.

Pharmaceutical Formulation and Processing – Part 2

This intensive, interactive four-and-a-half-day pharmaceutical training course is designed to provide aspiring QPs and other pharmaceutical professionals with the knowledge they need to understand the key quality requirements of parenteral products.

On both courses we teach you the important formulation requirements for each of these products and how those requirements influence the performance of the medicine in the body. We also teach you the key processing steps in the production of these dosage forms, critical process control points, process monitoring requirements, what can go wrong during the processing of medicinal products and the potential consequences of the safety, quality and efficiency of the medicine.

Once a new chemical entity has proved its potential in clinical studies, the challenge becomes formulating the compound into an effective medicine and manufacturing that medicine reliably so that safety, quality and efficacy are assured.

This course addresses two important activities of pharmaceutical formulation and processing and provides key information on:

  • How the physico-chemical attributes of the drug and the therapeutic indication influence:
    • Route of administration
    • Dosage form
  • Assuring bioavailability
  • Methods of manufacture of the major dosage forms
  • Factors affecting suitability for use of the major dosage forms

The QP and other key technical personnel must have a detailed understanding of these topics if they are to:

  • Assist in the design and implementation of relevant and effective quality systems for dosage form manufacture
  • Contribute to the risk assessment process for processing changes and unplanned deviations
  • Assess the adequacy of cleaning strategies
  • Assess the potential impact of changes to physical and chemical attributes of starting materials

This course is approved by the Royal Society of Chemistry as suitable for its members’ continuing professional development.

Key Learning Objectives

On completion of this course delegates will know and understand:

  • The principles of drug design and formulation and the impact of even minor modifications on bioavailability/bioequivalence
  • The various processes involved in the manufacture of major dosage forms, e.g. tablets, capsules, oral liquids, topical liquids, creams and ointments, sterile products and inhalation products
  • The Good Manufacturing Practice (GMP) issues and challenges for the QP to enable informed release decisions
  • How to apply the knowledge to:
    • Risk management
    • Risk assessment
    • Problem solving and decision making
    • Auditing

Course Outline

Part 1

  • Pre-formulation issues and product development
  • Routes of administration
  • Non-sterile dosage forms: Tablets, capsules, inhalation products, liquids, creams and ointments:
    • Major processing methods
    • Formulation challenges for each route of administration
    • Critical process steps
    • Key GMP requirements
    • What goes wrong and the role of the QP
  • Principles of technology transfer
  • Principles of process validation and control

Part 2

Parenteral Products

  • Design, qualification and operation of cleanrooms
  • Pharmaceutical water systems
  • Methods of sterilization and aseptic processing
  • Parametric release
  • Formulation considerations
  • Major processing methods
  • Critical process steps
  • Risk-based decision-making and the role of the QP
  • Key GMP requirements, Annex 1 and the contamination control strategy

Site Visit to Aseptic Facility

Who Should Attend

The Aspiring Qualified Person

  • Our pharmaceutical formulation and processing training course is generally considered as the best available and our QPs are held in high regard in the industry.
  • As well as being accepted in the UK, our training courses are well known and accepted by several 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.
  • Pragmatic training by experienced consultants supported by key academic staff from the University of Strathclyde, one of the UK’s top schools of pharmacy.

The Pharmaceutical Technical Professional

  • Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture and control.
  • Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development. Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications.

Course Tutors

All course tutors each have a minimum of 25 years’ hands-on experience in the manufacture of every major dosage form. APIs, biologics, tablets, liquids, creams, ointments, sterile as well as non-sterile dosage forms – you name it, they have made it.

Course tutors will be selected from the following:

Part 1:

Part 2: