Learn about the most overlooked aspect of product development i.e. raw material requirements in a cGMP environment. Starting from the role of water in determining the quality of product to the number of raw materials required - you’ll get thorough training on maintaining cGMP.
Introduction
Every biotech product is an amalgam of multiple raw materials that add purpose and efficiency to it. Since raw materials are the foundation of these products, it is important to have regulatory norms in place for them. Hence, this seminar discusses raw material compliance to ensure every final product meets FDA expectations and guidelines.
The training organizer has enforced the idea of good manufacturing practices through several pharmaceutical GMP training programs. However, minute elements like raw materials need critical attention to avoid warning letters.
The organizer has come up with this detailed course on raw material compliance to understand the intricacy of an ingredient in a product.
Course Overview
Did you know more than 5,000 firms received the notice for not having cGMP-controlled raw materials? This is not a scenario you dream of while running a pharmaceutical and biotech manufacturing business.
As much as the cGMP course plays an essential role, concerned personnel needs to understand regulatory requirements for raw materials. The basic framework of this course is different from cGMP online training.
It includes topics like testing and approval of the raw materials, rejection criteria of components, product container management, and closures.
As far as the benefits of pharmaceutical cGMP training are concerned, you will learn the following things:
- Basic guidelines to formulate representative samples for effective testing and inspection
- Best practices to release each component, packaged product, and closures
- Appropriate techniques to collect samples alongside preventing contamination, maintaining sterility in equipment, and aseptic processing
- General criteria for testing and examination of the samples
- Impact of multiple raw materials on the end user
- Adhere to the best practices required for commercial-grade manufacturing
FAQs
Q1: Is there any fixed number of raw materials as per raw material compliance?
Answer: No. There is no cap on the number of raw materials a manufacturing unit can source or procure. Sometimes a small molecule might require up to 20 components while a larger biomolecule may need more than 60 components. At the end of the day, the inspection team only looks after the regulatory norms followed by the individuals.
Q2: Does the course focus on minimizing pathogenic agent contamination in incoming raw materials?
Answer: Yes. Raw material compliance emphasizes avoiding contamination at every stage. Since the purity of the raw material impacts the quality of the final product, control strategies are discussed in this seminar.
Q3: What are the different components before the release of raw materials as per raw material compliance in the cGMP environment?
Answer: Before the release of raw materials, they need to be stored in controlled conditions. Furthermore, they are segregated and labeled as per the norms. The final step is to test these materials and qualify them for further use.
RAPS - This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Please note: Only one Dial-in is allowed for 1-10 user price option and can be set up in a conference room.