Lucid Pharmaceutical

20/03/2024

Read the full article by following the link below:

https://www.linkedin.com/feed/update/urn:li:activity:7176179182370971650

14/03/2024

Follow us on LinkedIn:
https://www.linkedin.com/company/lucid-pharmaceutical/

Critical Quality Attributes (CQA's) and Critical Process Parameters (CPP's) are crucial in the determination of your product specifications and equipment /system design. These terms are referenced in ICH Q8 - Pharmaceutical Development.

How do they work together and why are they necessary?

The relationship between CPPs and CQAs can be summarized as follows:

- CPP's directly influence the characteristics of the final product, as they are the key parameters during the manufacturing/production process.
- Changes in CPP's can lead to variations in CQA's.
- By understanding how CPP's impact CQA's, manufacturers can control and optimize the manufacturing process to consistently produce products with desired quality attributes.

Where do Risk Assessments fit in?

-The relationship between CPPs and CQAs is often established through risk assessment and scientific understanding of the process.
-Manufacturers analyze the potential impact of variations in CPPs on CQAs to identify critical parameters that must be tightly controlled.
-This understanding allows for the development of control strategies that mitigate risks associated with variations in CPPs and ensure the quality of the final product.

At Lucid Pharmaceutical Compliance, our Quality Management Systems include pre-designed SOP's and templates related to CPP's, CQA's and Risk Management procedures.

Contact us for more information.

31/08/2022

We are excited to welcome Kyle Bouwer to the Lucid Pharmaceutical Compliance team.

Kyle will be fulfilling the role of GMP and QMS specialist.

We wish you a fantastic journey ahead.

27/04/2022

In the video below, our CEO, Estian Schaefer, speaks about the different pharmaceutical facility design requirements to be considered before finalizing your facility design plans. The information in this video also pertains to cannabis facilities that are looking to adhere to GMP or EU-GMP standards.

https://lnkd.in/ek4SD-2j

22/02/2022

Complementary medicines: Licensing and Registration

In this article, our CEO Estian Schaefer discusses the licensing and registration of complementary ( Category D) medicines in South Africa.

http://www.lucidpharmaceutical.co.za/page1.html

09/02/2022

Video link: https://youtu.be/_4yhgG55UHM

In this video, our CEO Estian Schaefer and Jeff Verlinden discusses multiple critical topics related to compliance, investments and regulations in the medicinal cannabis industry.

The discussion touches on the following talking points:
* GACP vs GMP in the medicinal cannabis industry
* EU GMP certification
* Facility design considerations
* Qualification and Validation procedures
* Quality by design
* Opportunities for professionals in the medicinal cannabis industry

09/02/2022

Video link: https://youtu.be/_4yhgG55UHM

In this video, our CEO Estian Schaefer and Jeff Verlinden discusses multiple critical topics related to compliance, investments and regulations in the medicinal cannabis industry.

The discussion touches on the following talking points:
* GACP vs GMP in the medicinal cannabis industry
* EU GMP certification
* Facility design considerations
* Qualification and Validation procedures
* Quality by design
* Opportunities for professionals in the medicinal cannabis industry

In this video we go vertical on critical considerations that need to be applied to cannabis when positioning it at a botanical medicine/preparation. We speak...

04/02/2022

GACP vs GMP compliance in the cannabis industry.

Read more about it in the link below:

Understanding the difference between GMP and GACP in the cannabis industry is crucial to your future business activities, including facility design, equipment...

19/01/2022

At Lucid Pharmaceutical Compliance, we provide end-to-end consulting services to Pharmaceutical, Biopharmaceutical and Agricultural projects.

Visit our website, www.lucidpharmaceutical.co.za, to see what we have to offer and how we can support your project's specific needs.