ICH Q10 guidelines basically mention the effective Pharmaceutical quality system (PQS). the pharmaceutical quality system is based on the ISO quality system including good manufacturing practice (GMP) regulations. Relationship Between ICH Q8, ICH Q9 and ICH Q10 Before the ICH Q10, ICH Q8 (Pharmaceutical development), and ICH Q9 (Quality risk management) were implemented throughout the … Read more
Change is driven by innovation, continuous improvement, process performance and product quality monitoring, and CAPA. A firm must have an effective change management system in place in order to effectively review, authorize, and execute these changes. The complexity of change management processes before the original regulatory submission and after submission, where revisions to the regulatory … Read more
The world is evolving rapidly, with new diseases and disorders emerging, leading to a higher demand for novel discoveries, including new drug findings. There is consistently high demand for aligning medicinal products to uphold and ensure quality, safety, and efficacy standards for each product. The ICH Guidelines for pharmaceuticals play a significant role in ensuring … Read more
Interview questions regarding accelerated stability testing/studies are explained following the ICH (Q1A, R2, and Q1B step 5) and FDA guidance. Conducting stability studies is important to ensure the quality, safety, and efficacy of drug products throughout their lifecycle, which is a prerequisite for accepting and approving any pharmaceutical product. These accelerated stability studies must be … Read more