Quality Control » Pharmaguddu

Media Fill Procedure and Protocol: Step-by-Step Guide for Pharmaceutical Industry

Flow diagram of the media fill procedure and protocol from sterile growth medium to incubation, inspection and result

How a media fill is planned, run, incubated, evaluated and approved, with the Annex 1 and FDA rules for acceptance, failure and requalification.

System Suitability in HPLC

System suitability in HPLC shows, before each run, that the whole system gives valid results. Learn the parameters, a worked example and what to do when SST fails.

Trend Analysis in an APR with control charts and Cpk

How to trend batch data in an APR: choose the control chart, check stability, calculate Cpk with a worked example and write a clear conclusion.

OOE (Out of Expectation) in Pharma QC?

Comparison of out of expectation OOE pharma results with OOS and OOT, shown as three columns with a decision order

OOE means an in-spec result that looks unusual. See how it differs from OOT and OOS, with an HPLC peak example and a simple review process.

HPLC Causes of False OOT Results and How to Fix Them

Infographic showing HPLC false OOT results arising from records, reference standard, column, mobile phase, calibration and integration

Which lab errors give HPLC false OOT results? A checklist of records, standards, column, mobile phase and integration checks, with fixes.

Alert Limit vs Action Limit in OOT Trending

Alert limit vs action limit OOT infographic comparing specification, alert and action levels and what each triggers

Alert limits give an early data check; action limits start a formal investigation. Learn how to set both for OOT trending and write them into the SOP.

How to Investigate an OOT Result in Stability Testing

Decision flow chart for OOT investigation in stability studies from confirming the flag to a documented conclusion

Learn the decision flow for an OOT investigation in stability studies, from the first flag to a documented conclusion and CAPA decision.

How to Identify OOT in Stability Studies: Statistical Methods

OOT in stability studies: comparison of regression control chart, by-time-point and slope control chart methods

Learn how to find OOT in stability studies with regression, tolerance interval and slope methods, and follow a worked assay example.

OOT vs OOS in Pharma: Differences and Investigation

OOT vs OOS in pharma comparison panel showing OOS, OOT and OOE with limit, trend and release decision

OOS breaks a limit and blocks release. OOT breaks a pattern and needs assessment. Learn the differences, investigation steps and release decisions.

Out of trend (OOT) results in Pharmaceutical Quality control

OOT results pass specification but break the usual pattern. Learn how to detect them, how they differ from OOS, and how to investigate them.

Common Problems and Troubleshooting for Disintegration Test Apparatus

Disintegration test troubleshooting guide showing common USP/Ph. Eur. tablet disintegration apparatus problems, causes, and corrective actions.

Have you ever asked yourself why a tablet, which has passed all the other quality control tests, fails the QC bench? A disintegration test apparatus is used to determine whether a tablet or a capsule disintegrates within a specified time under defined conditions. The test is performed by vertically reciprocating the unit in a liquid maintained at human body temperature. This article describes the working principle of the disintegration test apparatus, its components, the procedure for the disintegration test, calibration, and the disintegration limits set by the manufacturers for different dosage forms. This information will help QC and manufacturing personnel to perform the disintegration test properly and release the batches of the pharmaceutical products.

0.1M Perchloric Acid Preparation and Standardization Procedure (IP Method)

Infographic to prepare Crystal Violet Solution with step-by-step procedure, quantity of reagents, adjustment of water content, Karl Fischer testing, storage and quality control points.

Know the step-by-step procedure used to prepare and standardize 0.1M perchloric acid solution as per IP guidelines. Incorporates reagents, equipment, calculation, detection of endpoint, storage of reagents, and standardization with potassium hydrogen phthalate (KHP).

0.004 M Benzethonium Chloride Solution Preparation and Standardization Procedure

Detailed infographic for the preparation, standardization, titration principle and equivalence factor for a pharmaceutical quality control laboratory 0.004 M solution of benzethonium chloride

Preparation and standardization of 0.004 M benzethonium chloride solution with potentiometric titration with 0.1 M perchloric acid. It deals with preparation of reagents, calculation of standardizations, equivalence factor and recommendation on storage for pharmaceutical laboratory applications.

How to Prepare and Standardize 0.05 M Silver Nitrate (SOP)

Infographic showing the preparation, standardization procedure, calculations, and endpoint for 0.05 M silver nitrate solution in pharmaceutical analysis.

Here is the exact process for making and standardizing 0.05 M silver nitrate. Includes the chemicals, the titration procedure and the formula to calculate and storage condition

Preparation and Standardization of 0.025 M Sulphuric Acid Solution

Infographic of preparation and standardization of Sulphuric acid solution 0.025M with anhydrous sodium carbonate showing preparation steps, titration procedure, methyl red indicator, calculation formula and laboratory apparatus.

Know how to prepare 0.025 M sulphuric acid solution using anhydrous sodium carbonate, methyl red indicator, calculations and titration procedure.

How Perform Limit Test for Heavy Metals (SOP)

Complete reagent preparation guide for LIMIT TEST FOR HEAVY METALS ( BP) - steps for preparation of acetate buffer pH 3.5, thioacetamide reagent, lead standard solutions, hydrochloric acid, ammonia, phenolphthalein.

Limit tests for heavy metals need not be confusing. This guide includes detailed protocols with equipment, reagent preparation and step-by-step instructions to perform a typical test procedure. For all of the Test A, B, C and D options, there are clear instructions to ensure your pharmaceutical quality control is accurate and on track. 1.0 Scope: … Read more