QA & QC
Common QC Lab Errors in Pharma
Q: What are the major root causes of QC lab errors? Q: What is a common error in HPLC sample preparation? A: Improper sample dissolution leading to inaccurate quantification, peak area variability, and inconsistent retention times. Q: What are the root causes of this issue and How it resolved? A: ... Read More
Level III Biorelevant Media
At Level III of biorelevant media simulation, a comprehensive replication of the gastrointestinal (GI) tract environment includes factors such as luminal osmolality, pH range, buffer capacity using specific buffer ingredients, bile components, dietary lipid components, dietary proteins, increased viscosity (notably in the fed stomach and lower intestine), and the replication ... Read More
Level II Biorelevant Media
Developing accurate models of the gastrointestinal (GI) tract is paramount in pharmaceutical research to predict how drugs interact with the human body. Level II biorelevant media emerges as a sophisticated tool to mirror the intricate conditions within the GI system, playing a pivotal role in enhancing drug formulation and assessment. ... Read More
Level I Biorelevant Media
When studying drug dissolution in the gastrointestinal (GI) tract, simulating realistic physiological conditions is crucial for accurate results. Enter Level I biorelevant media – a novel approach to create in vitro environments that closely mimic luminal pH and buffer capacity in different regions of the GI tract. At Level I, ... Read More
Level 0 Biorelevant Media
Biorelevant media were initially proposed in 1998 to study the dissolution of poorly soluble drugs in the gastrointestinal (GI) tract. Over time, different media have been developed to mimic various parts of the GI tract in both fasted and fed states. For the fasted state, there are specific biorelevant media ... Read More
Trend Analysis for Elemental Impurities
Trend analysis for elemental impurities is not explicitly required by guidelines like ICH Q3D . However, certain aspects of stability trends and variability need to be considered to ensure compliance and accurate reporting. Stability Trends for Elemental Impurities In most cases, if no such risk is identified, monitoring for trends ... Read More
Mind Mapping Tool for Investigations
Mind mapping can be an incredibly effective tool in pharmaceutical investigations, helping teams structure their thinking, uncover connections, and generate insights systematically. Here’s how it can be applied effectively: Applications of Mind Mapping in Pharmaceutical Investigations Root Cause Analysis: During investigations of deviations, out-of-specification (OOS) results, or adverse events, mind ... Read More
How do We Ensure that Split Tablets Maintain Dose Accuracy and Stability?
For those who need flexible dosing, tablet splitting (for tablets with a functional score-line) can be helpful, but it’s essential to ensure each piece is consistent and effective. Here’s a quick look at the *key tests and acceptance criteria to assess splitting of scored immediate-release tablets. To ensure quality and ... Read More
How Glassware Could Be Sabotaging Your Dissolution Results?
We often assume that inconsistent or low drug release during dissolution testing to product performance issues or instability of the drug at a certain pH. But here’s the twist—sometimes the problem isn’t the drug or the formulation at all. The real culprit could be the glassware you’re using during the ... Read More
Understanding Stratified Sampling in Pharmaceutical Industry
FDA recommends the necessity of statistically sound sampling plans [Intra-Location (within a single location) Variability and Inter-Location (between locations) Variability] and acceptance criteria [acceptable range of deviation from the mean content, the variability of measurements, and the percentage of units falling within predetermined limits is based on statistical principles] to ... Read More