Cleanrooms are specialized zones that are designed in such a manner that it has very low levels of particulate matter. These particulate entities may comprise of dust, airborne organisms, or vaporized particles. The cleanroom pass boxes are used for transporting items or components in and out of the cleanrooms. Apart from providing full protection, the … Continue reading Importance of Pass Box in Pharmaceutical industry →

Attributable : Data Integrity Issues Attributable means information is captured in the record so that it is uniquely identi­fied as executed by the originator of the data (e.g. a person or a computer system). Common User ID and Password or Sharing Disable of Audit Trail: Not able to identify the person who did the activities … Continue reading Data Integrity issues in Pharmaceutical Industry and Mitigations Strategies →

1.      Introduction The purpose of this SOP is to describe the procedure that should be followed during all shipping Qualification (SQ) activities. 2.      Scope This SOP applies to the qualification of all shipping configurations. This includes, and not limited to, intermediates, finished goods (full and partial load) and cold chain shipping configurations. This SOP will … Continue reading Shipping Qualification →

Roller Compactor What is Roller Compaction : The Roll Compactor machine is used for increased bulk density, making granules, dust free processing and reducing particle size of pharmaceutical ingredients in pharmaceutical industry, in food as well as chemical industry for densification and granulation of powder. Roller compaction is a method of powder compaction of dry … Continue reading The Working Principle of Pharmaceutical Roller Compactor →

Stability Chamber What is Stability Testing : Stability testing is the process by which pharmaceutical manufacturers observe their product over predetermined lengths of time in specific environmental conditions to determine if there is any change in the quality of the Active Pharmaceutical Ingredient (API) or Final Product (FP). When manufacturing pharmaceuticals and other FDA-regulated products, … Continue reading Pharmaceutical Stability Testing Guide →

Annual Product Quality Review (APQR) is a review report required by regulations from different healthcare regulatory authorities. When following the process, the medicine manufacturer required to periodically review that the finished products are consistently meeting the implemented quality standards for the product under review. APQR is also called as Annual Product Review (APR) or Product … Continue reading Annual Product Quality Review (APQR) →

Introduction : Audit is the examination or inspection of various books of accounts by an auditor followed by physical checking of inventory to make sure that all departments are following documented system of recording transactions. It is done to ascertain the accuracy of financial statements provided by the organisation. This is the generic definition of … Continue reading Types of audit in pharmaceutical industry →

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