Manufacturers should ensure that the products are safe, effective and of the quality required for their intended use. Systems should be in place to ensure that pharmaceutical products are produced according to validated processes and to defined procedures. Manufacturing processes should be shown to be capable of consistently manufacturing pharmaceutical products that are of…
Robustness in analytical method validation is a critical aspect of ensuring the reliability and accuracy of analytical results. It refers to the ability of an analytical method to remain unaffected by small, deliberate variations in method parameters while still providing consistent and reliable results. Importance of Robustness in Analytical Method Validation Reliability of Results: The…
Before the answer to the above question first, we should be aware of validation. What is Validation? Validation is documented evidence that ensures that a process or procedure consistently produces a product with the same quality standards. Validation has great importance in pharmaceutical industries because, for every product manufacturing, we conduct a validation…
Since there is no ICH guideline on Analytical Procedure Development, applicants often report analytical validation results alone and rarely present performance evaluation with analytical development outcomes. This makes regulatory communication ineffective especially when non-conventional (for example, real time release testing) analytical procedures are employed. Additionally, the lack of guidelines precludes the applicant from…
Pharmaceutical formulations are the specific compositions and preparations of API (s) and excipients. These formulations are designed to ensure the safe and effective delivery of medications. There are several types of pharmaceutical formulations, each tailored to meet specific patient needs and drug characteristics. Here are some common types of pharmaceutical formulations: Tablets and Capsules:…
Gummy vitamins have become increasingly popular as an alternative to traditional pill or capsule supplements,. They are typically made from gelatin, corn starch, sugar, and lots of fillers and chemical additives. But like any product, they come with their own set of pros and cons. It’s essential to consider these factors before deciding whether gummy…
Human performance errors in analytical laboratories are more common than we think! Let’s dive into some of the most common errors that can impact the accuracy and reliability of analytical results. Data entry errors: Accurate data entry is crucial for reliable analysis. Incorrectly entered data can lead to misleading results or flawed analysis. …
Process Capability & Performance Indicators (Pp, Ppk, Cp, Cpk) are specification indicators relative to process dispersion and process centering. Process capability is a statistical measurement of a process’s ability to produce parts within specified limits consistently, to meet the design specification for a service or a product. Process capability is expressed as 6σ,…
