A strong risk and quality control strategy is essential to ensuring the safety, efficacy, and consistency of pharmaceutical manufacturing. By identifying and addressing potential risks early, we prevent costly errors and delays, ensuring smooth and efficient manufacturing of your products.

IDT Biologika is a leading cell & gene therapy CDMO with an exceptional track record in biologics manufacturing and an outstanding expertise with live viral agents.

Our strategy ensures high product quality by upholding strict standards and continuous monitoring throughout the production process. All analytical services for our customers products are carried out in-house.

For our customers, it translates into a faster time-to-market, improved collaboration through transparent processes, and reduced costs by minimizing compliance issues. Ultimately, it demonstrates our commitment to our customers and their products while building builds trust for a long-term partnership.

At IDT Biologika, our Quality Risk Analysis and Control Strategy is based on 5 pillars. Each of these elements plays a key role in ensuring that the final product is safe, effective, and of the highest quality.

Facility and Equipment Qualification: Ensuring that facilities and equipment meet regulatory standards is crucial for maintaining product quality. Qualified facilities and equipment minimize the risk of contamination and ensure consistent, reliable production processes. This not only protects product integrity but also boosts operational efficiency by reducing downtime due to equipment failures.

Qualification and Control of Raw Materials: The quality of raw materials directly influences the final product. By rigorously qualifying and controlling raw materials, we can prevent variability and ensure that each batch meets the required specifications. This practice reduces the risk of product recalls and enhances the overall reliability of the manufacturing process.

Qualification/Validation of Analytical Methods: Validating analytical methods ensures they are accurate, reliable, and reproducible. This is essential for consistently measuring product quality and ensuring compliance with regulatory standards. Validated methods provide confidence in the data generated, which is critical for making informed decisions throughout the product lifecycle.

Continuous Operator Training and Education: Regular training and education for our employees ensure they are up-to-date with the latest procedures and technologies. Well-trained employees are more likely to adhere to protocols and identify potential issues before they escalate. This not only improves product quality but also enhances workplace safety and operational efficiency.

Stability Studies at All Process Stages: Conducting stability studies at various stages of the process helps us understand how the product behaves under different conditions over time. These studies are critical for determining the product’s shelf life and storage conditions. By ensuring that the product remains stable and effective throughout its intended shelf life, we can provide greater assurance of product quality to our clients.

In summary, a comprehensive risk and quality control strategy encompasses key elements, from facility and equipment qualification to continuous training and stability studies. Each of these components plays a vital role in ensuring that the final product is safe, effective, and of the highest quality. For our clients, this translates to reduced risks, lower costs, and faster time-to-market, ultimately leading to more successful and sustainable partnerships.