Formulation and Processing

The QP must understand formulation and processing principles to make informed certification and release decisions.

This course is delivered in two parts:

Part 1 – Non-sterile products (Virtual, February)

This interactive course helps aspiring QPs and pharma professionals understand key quality requirements for manufacturing capsules, liquids, topical medicines and inhalation products.

Part 2 – Sterile products (In-person, March)

This intensive course provides the knowledge needed to understand essential quality requirements for sterile product manufacture. We explain formulation requirements for each product type and how these influence performance, along with key processing steps, critical quality attributes and process parameters. We also cover common processing issues and their impact on safety, quality and efficacy.

Once a new chemical entity shows clinical potential, the challenge becomes turning it into an effective, reliably manufactured medicine. This course covers the formulation and processing activities required to ensure safety, quality and efficacy.This course provides key information on:

• How the physico-chemical attributes of the drug and the therapeutic indication influence:
  • Route of administration
  • Dosage form
  • bioavailability
• Manufacturing methods for major dosage form
• Factors affecting suitability of major dosage form

QPs and pharma professionals must understand these topics to:

• Support design and implementation of effective quality systems
• Contribute to risk assessment for process changes and deviations
• Assess cleaning strategies and validation activities
• Evaluate the impact of changes to starting materials

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

Our A-Z of Sterile Products Manufacture course can be used as an alternative to the Pharmaceutical Formulation and Processing Part 2 training if you're working towards gaining QP eligibility and this course's dates are not suitable. 

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

• Design, qualification and operation of cleanrooms
• Pharmaceutical water systems
• Methods of sterilization and aseptic processing
• 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

Each course tutor has at least 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:

Part 1: Catherine Kay, Samantha Clack, Vicky Baulch, Lecturer from the University of Strathclyde

Part 2: Darren Jones, Phil Rose, Marie O'Callaghan

Discounts

Multiple delegate discounts are available on this course. Please contact us at [email protected] for further information. NHS staff will receive an automatic discount when registering with an NHS email address.