Active Pharmaceutical Ingredients (API) Auditing

Auditing API Manufacturers: Ensuring Patient Safety and Regulatory Compliance

One of the key focus points when auditing Active Pharmaceutical Ingredient (API) manufacturers is the responsibility to ensure patient safety. This course is designed to provide the assurance required to meet product safety and regulatory expectations. 

 

Providing the skills to enable effective auditing and reporting on suppliers of APIs, this training considers the requirements of ICH Q7 and EU GMP Part II, as well as the expectations of regulatory bodies, both in the USA and Europe. 

 

Interested in audit training for your team? Contact us today. 

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Duration
1 day
CPD Hours
7 hrs
Locations
  • Online

Who Should Attend

The course is suitable for those who have had some auditor training and experience in conducting audits. The training has been specifically designed for those responsible for assessing the content and findings of API audit reports as part of license applications and variations, as well as Qualified Persons responsible for the release of pharmaceutical products. 

Key Topics

This course covers the following topics:  

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    Legal and GMP basics 

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    Audit preparation 

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    Product specific information 

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    Materials handling 

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    Manufacturing methods and equipment 

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    Cleaning validation 

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    Introduction to process validation 

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    Production and packing APIs 

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    Good Clinical Laboratory Practice (GCLP) including data integrity 

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    QMS and product release 

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    Close out, reports and follow-up 

Learning Outcomes

This course will be assessed and certified by RSSL against the standards of ICHQ7. 

By the end of the course, you will: 

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    Understand the regulatory requirements for conducting API audits 

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    Be able to provide background information and scope for a supplier audit 

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    Be capable of creating a structured approach in preparation for an API audit 

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    Be able to conduct an API audit 

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    Know how to create a check list of questions to ask 

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    Be able to identify nonconformities against ICH Q7 and regulatory expectations 

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    Be able to identify product specific requirements 

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    Have knowledge on the basic manufacturing techniques and equipment used 

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    Understand the requirements for GCLP 

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    Know how to produce a report that will satisfy the sponsor organisation as to the ongoing status and compliance of the API supplier 

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    Be able to produce a report that demonstrates the continuing suitability and certification of the API(s) in question 

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    Know how to obtain auditee cooperation and acceptance of findings 

Meet your expert tutors

Learn from the best in the industry.  Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you. 

David Abraham

David Abraham

With extensive knowledge of business operations and processes, manufacturing operations, logistics and pharmaceutical industry applications, David has operated in and alongside working parties at national and international level. Developing guidance and standards for the industry, David is held in high regard within the industry and has been instrumental in the development of the PS 9000 publications.
Rob Hughes

Rob Hughes

Rob has more than 40 years' experience in the pharmaceutical industry spanning various operational, project and senior strategic leadership positions in commercial manufacturing and development QA. With experience of the application of QA across control laboratories, API, solids, creams and liquids manufacture and third-party audit and evaluation, Rob’s knowledge makes him a valued member of our pharmaceutical training programme.
Frequently asked questions

If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.

What our clients say

Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development. 

Fast paced, jam packed

Fast paced, jam packed, very good insight and lots of pointers to assist in API auditing. This is a course for experienced auditors who are new to API auditing or want to refresh their API knowledge.
Yvonne Mccormack
Amivas Ireland - Associate director of Quality & Compliance

I learnt alot

The trainer had lots of examples from the industry. I felt like I was on a training audit with him. He was easy to listen to and I trusted him – he was very easy to build a report with and I learnt a lot from him.
Anonymous
Global Pharmaceutical Company - Lead Auditor

Book Your Place

Active Pharmaceutical Ingredients (API) Auditing
20 Feb 2025
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Online
05 Nov 2025
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Online
£590 excl VAT
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Bespoke Training

We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.

Bring this course in-house Bring this course in-house

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Why choose RSSL?

As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.

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    More than 30 years of experience upskilling pharmaceutical professionals

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    Small-group training adjusted to individual learning styles and needs

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    50+ training courses accredited by recognised industry bodies

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    Combination of off-the-shelf and bespoke training packages

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    Courses and consulting led by experts in the entire pharmaceutical life cycle

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    Opportunity to share and learn as part of a diverse community