🔬 Sharing Pharmaceutical Insights: Understanding Related Substances in Drug Substance and Drug Product 🔬
Ts. Muhammad Hariz Bin Said
Professional Technologist (Biotechnology) | Product Transfer | Pharma R&D | Regulatory | Project Management
After five years in the pharmaceutical industry and as a professional technologist, I suddenly realised that it's about time I start sharing some valuable knowledge with those new to the pharma community. Today, let's delve into the topic of impurities/related substances in drug substances and drug products, exploring key insights from ICH guidelines.
1️⃣ ICH Q3A - Impurities in Drug Substance:
Within ICH Q3A, we find essential guidance on the identification and control of impurities specifically in drug substances. These guidelines play a crucial role in ensuring the safety and efficacy of our products at the drug substance level.
2️⃣ ICH Q3B - Impurities in Drug Products:
Complementing the Q3A guidelines, ICH Q3B focuses specifically on impurities in drug products. It provides guidance on how to identify, control, and manage impurities to maintain the quality and safety of the final pharmaceutical formulations.
3️⃣ Impurity Thresholds:
When it comes to impurity control, there are key thresholds we must consider:
- Reporting Threshold: Impurities that approach or exceed this level require reporting and appropriate action.
- Identification Threshold: Once an impurity surpasses this threshold, identification becomes necessary for proper characterisation and understanding.
Recommended by LinkedIn
- Qualification Threshold: Above this threshold, it is crucial to evaluate and qualify the impact of impurities/related substances on health and safety.
4️⃣ Designing Impurity Profiles:
When designing the impurity profile for a new drug substance or drug product, these thresholds serve as convenient limits accepted by many national regulating authorities. Here's how we utilize them:
- Unknown Impurities: We use the identification threshold as the limits for any unknown impurities. If an impurity appears below this threshold, it can be reported as "unknown" without the need for identification.
- Known Impurities: For known impurities, we rely on the qualification threshold as the limit. However, if the level of known impurities exceeds the qualification threshold, we can use additional measures such as toxicology studies, literature review, or referencing similar products to justify our chosen limits.
The guidelines are dynamic and it is important to keep ourselves updated.
Let's come together and engage in insightful discussions on these topics. Feel free to share your experiences and thoughts, contributing to our collective knowledge.
Head of Engineering
1yAs an engineer I used to work in clean room which is called Sterile plant. It is very easy to maintain the ISO classification if only follow what the c GMP standard
IKM Member, Graduate Technologist
1yAnalytical pharma testing please