As a Stability Assessor at the Egyptian Drug Authority, I frequently review CTD files, and I’ve noticed recurring mistakes in the Analytical Method Validation section. These oversights not only delay regulatory approvals but also question the reliability of the data presented. Here are some common pitfalls to avoid: 1. Incomplete Validation Reports: Failing to address…
Title and Identification:Including the type of test being performed, batch number, sample ID and date of analysis. Procedure Steps:Clearly outlining each step of the test method and procedures along with the references. Raw Data Entry:Areas to record experimental observations, instrument readings and raw data. Additional data prints like spectra should be attached. Calculations:Sections to perform…
Pre-Validation Requirements: Specificity: Linearity and Range: Accuracy and Precision: Robustness: Limit of Detection & Quantitation: System Suitability: Observations and Deviations: Analytical test method validation is a cornerstone of scientific accuracy and precision. Read also:
These tests are designed to confirm the identity of the active pharmaceutical ingredient (API) and other components in a drug formulation. The identification of pharmaceuticals is a fundamental step in quality control, as it helps prevent errors in manufacturing and ensures that the final product meets the required specifications. Here are some common identification tests…
pH is a measure of a solution’s acidity or alkalinity. In the pharmaceutical industry, pH is important because it can affect the stability, efficacy, solubility, and bioavailability of drugs: pH is mesured in the pharmaceutical industry to check/ensure: 1. Drug stability The stability of many drugs is affected by pH. For example, some drugs…
USP <711> contains a couple references to pooled sampling for dissolution. What is pooled sampling and when is it appropriate? What risks are there with pooled sampling? Pooled sampling is a procedure where each sample from a dissolution time point is combined into a single sample. Pooled sampling is only done for immediate-release dosage…
Prerequisites is usually a checklist which is sent to the Receiving Laboratory which in most of the cases is the Quality control laboratory of the manufacturing. This checklist is prepared by the Department or the team which is involved in the method validation/verification/transfer activity and contains all the things which are required and needed…
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…
