Active Pharmaceutical Ingredients (API) Auditing
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.
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.
This course covers the following topics:
Legal and GMP basics
Audit preparation
Product specific information
Materials handling
Manufacturing methods and equipment
Cleaning validation
Introduction to process validation
Production and packing APIs
Good Clinical Laboratory Practice (GCLP) including data integrity
QMS and product release
Close out, reports and follow-up
This course will be assessed and certified by RSSL against the standards of ICHQ7.
Understand the regulatory requirements for conducting API audits
Be able to provide background information and scope for a supplier audit
Be capable of creating a structured approach in preparation for an API audit
Be able to conduct an API audit
Know how to create a check list of questions to ask
Be able to identify nonconformities against ICH Q7 and regulatory expectations
Be able to identify product specific requirements
Have knowledge on the basic manufacturing techniques and equipment used
Understand the requirements for GCLP
Know how to produce a report that will satisfy the sponsor organisation as to the ongoing status and compliance of the API supplier
Be able to produce a report that demonstrates the continuing suitability and certification of the API(s) in question
Know how to obtain auditee cooperation and acceptance of findings
Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you.
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.
Yes, the API Auditing course can be delivered in-house for your organisation. This can be arranged as an on-site course at your premises, or as a virtual tutor-led in-house course. Please see our In-house Training page for details.
Places will be available for you to book unless it states ‘Full’ next to your chosen API Auditing course date. When this occurs, we operate a waiting list service.
Yes, we welcome bookings from self-sponsoring individuals. Once your booking has come through to us, we will ask you to complete a new customer form and provide a scanned copy of your photographic ID so that we can raise an account for you on our systems.
You will need to first register yourself on our booking system by selecting the API Auditing course date that you wish to book your colleagues onto, then:
You will receive an automated email confirming your booking details for the API Auditing course. 10 days before the start date, if the course is confirmed to run, you will receive another email including the final course details. If the course is to be held virtually, the online registration and joining instructions will also be included.
Usually, this 1-day API Auditing course is delivered live by our tutor, virtually on the Adobe Connect training platform. If you are looking for in-person training only, please get in touch with the team to discuss your needs via trainingsales@rssl.com or +44 (0)118 918 4000.
When online, this course begins at 08:45am, although we request that you login at 08:30am for registration. For our in-person courses, refreshments are available from 08.30am, for a 08:45am start. The standard finish time is 17:00pm, though some courses will finish slightly earlier or later.
Please review your course confirmation email to double check the exact start time of your specific course. If you need an exact finishing time to allow for travel arrangements, please contact us via trainingsales@rssl.com or +44 (0)118 918 4000.
Your invoice will be sent approximately 30 days prior to the course start date. If you are a new customer to RSSL, shortly after we receive your booking, you will be asked to complete a New Customer Form so that an account can be created for you on our finance system.
Yes, companies wishing to book multiple employees on one of our standard training courses (excluding IRCA Lead Auditor courses) can benefit from our group booking discount. This discount is only applicable to bookings made for the same course on the same date. Please contact trainingsales@rssl.com with your requirements and we will be happy to provide more information on the best deal available for you.
Yes, we offer NHS Trusts a 20% discount on ALL our courses, including our Qualified Person training programme. When booking your course/s enter 'NHS' in the discount code field so that your discount can be applied on your invoice. Please note that the NHS discount code is only valid when the booker uses a NHS email address.
Yes, certificates of attendance are issued after we have received payment in full for the course. If you have not received your certificate, please contact your own finance department to confirm if they have sent payment to us. All certificates are issued electronically by email.
As RSSL run all of our virtual courses on Adobe Connect, we recommend that you download the latest version of the Adobe Connect Application at the time of your course - click here to visit the download webpage.
Please see our 'minimum requirements' downument for further details on what you'll need to attend our virtual courses. You can test that the Adobe Connect application works for your organisation by completing the RSSL Adobe Connect Function Test.
Yes, we are more than happy to welcome delegates from all over the world. Our virtual tutor-led courses are particularly popular with international attendees.
All we request is that you have a good understanding of written and spoken English so that you can get the most out of the course. If you wish to attend an in-person course, please also check any visa requirements and await RSSL's full course confirmation before booking your travel to the UK.
Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development.
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.
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.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community
