QP active pharmaceutical ingredients

2 Day/s

CPD Hours: 14

Classroom, online, in-house

RSC approved

The Qualified Person must understand the influence of manufacturing pathways and associated physical and physico chemical attributes of both active pharmaceutical ingredients and major excipients on the quality of the finished dosage form.


QP responsibilities also include formally certifying that each Active Pharmaceutical Ingredient (API) is manufactured to GMP, knowledge of the API supply chain and complying with importation requirements as defined in the Falsified Medicines Directive. This course includes both the technical aspects of manufacturing APIs and the requirements of Good Manufacturing Practice.

RSC Logo Approved Training High Res (1)
This is an essential course for all those who expect to be taking the QP Viva, it is also a valuable contribution to Continuing Professional Development for QPs who qualified some years ago. This is also suitable for those who require an understanding of the requirements for manufacturing APIs such as purchasing, manufacturing or regulatory affairs staff.
This course includes the following topics:


  • Day 1
    • Methods and equipment including virtual tour of chemical facilities
    • Methods and equipment for Bio APIs
    • GMP requirements for API’s-Eudralex Vol 4
    • GMP requirements FMD and GDP
    • GMP requirements ICH and impurities
  • Day 2
    • Registration aspects including QP declaration exercise
    • Laboratory controls
    • Process validation overview
    • Cleaning validation overview
    • Supply chain and QP responsibilities
    • The control of API packaging materials
    • API audit situations

    At the end of the course you will know:


    • The role of the QP relevant to APIs
    • The regulatory framework for the manufacture of APIs
    • The requirements of the Falsified Medicines Directive and APIs
    • How to use the European Guide to GMP for APIs
    • The contents of a drug master file
    • Methods and equipment used in synthesis
    • Requirements for specifications, organic solvents and impurities
    • Process and cleaning validation
    • The control of packaging materials for an API

Book your place
Select Date & Location
£

ex VAT

Bring this course in-house
Go

Special offer

Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Graham Saunders

Graham is a permanent provisions eligible Qualified Person (QP) who has gained extensive QC and QA experience within the Pharmaceutical Industry since 1983. Recent positions have focused upon the application of GMP and design/implementation of Quality Systems at international manufacturing Sites and R&D facilities - with extensive experience gained on all commercial dosage forms plus Active Pharmaceutical Ingredients (API) and Investigational Medicinal Products (IMP).

Rob Hughes

Rob Hughes has over 30 years in the pharmaceutical industry spanning various operational, project and senior strategic leadership positions in commercial manufacturing and development QA. Rob, a practising QP, has experience of the application of QA in many different areas including control laboratories, API, solids, creams and liquids manufacture, and third party audit and evaluation. Rob has many years experience of MHRA and FDA inspections.

Related course

Shutterstock 561802183 (2)

Active pharmaceutical ingredients auditing

The course provides the knowledge and skills to enable effective auditing and reporting of audits on suppliers of active pharmaceutical ingredients (APIs).