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Cleaning of laboratory glassware is the key for success of an analysis in the Pharmaceutical Quality Control Laboratory. Even the maximum cautiously performed laboratory analysis can produced erroneous/wrong results if uncleaned glassware is being used during the analysis. If the glassware that is used for measuring solvent / sample solution or standard solutions is contaminated […]

This article is to describe the process and requirements regarding Sample Management in Quality Control Laboratory , including the receipt, handling, controls, maintenance, distribution for testing, and destruction. The implementation of this procedure provides documented records of the chain of custody for the test samples to ensure their accountability and tractability. This article (Laboratory Sample […]

A cleaning validation protocol format shall be developed for the ‘worst case’ product selected for cleaning validation programme. Following information (but not limited to) the following included in the cleaning validation protocol. Numbering of protocol shall done through of respective SOP of Cleaning Validation Protocol Numbering. Cleaning Validation Protocol Format – Objective: A brief description […]

Introduction: Cleaning validation Master Plan will function as an umbrella guidance document for all the cleaning validation protocols, programs, and procedures adopted to ensure that all the equipment utilized for the manufacturing of tablets and hard gelatin capsules dosage form are cleaned up an acceptable level. The Pharmaceuticals manufacturing entities which  engaged in manufacturing of […]

A Complete Guide on HPLC Calibration – Part 3 of 3 (Continued…) In the HPLC Calibration – A complete guide article series, we have discussed about Monthly & Quarterly Calibration parameters, rest of the parameters are described below, in the end of the article all the relevant links has mentioned, in this article there are […]

Continued from …. A Complete Guide on HPLC Calibration -Part 1 of 3 Part 2 – HPLC Calibration on different Parameter starts from Energy check and completed on wavelength accuracy of Detector In the previous article on HPLC Calibration we have covered following parameters. Pressure Test. Drift and Noise Column oven and sample cooler Pump […]

HPLC System Calibration is the most critical activity in the laboratory, HPLC System is the most sophisticated instrument in the Pharmaceutical Laboratory. Calibration of an instrument is the demonstration that the instrument or device produces results within specified limits by comparison with those produced by reference or traceable standard over an appropriate range of measurement. […]