COMPRESSED AIR TESTING IN PHARMA
The Quality of Compressed air is important to ensure that product is safe. The most important parameters in specifying Compressed air quality are: Dew Point…
Category: Pharma Industry Guidelines
CHANGE CONTROL IN PHARMA
Change control:- Change control is a strategic activity to bring about changes in document/process/method. It can be for the smaller period of time or it…
DEVIATION
DEVIATION:- Deviation is an unexpected event that occurs during the on-going operation / Activity / Documentation / Entries at any stage of Receipt, Storage and…
SELF INSPECTION OF PREMISES
A systematic inspection program to detect any shortcomings in the implementation of cGMP and to recommend necessary corrective actions. Manager QA/Head QA shall nominate the…
WHY STERILITY TEST REQUIRE 14 DAYS OF LONG INCUBATION TIME
To identify the viable contamination (bacteria, fungus, spores etc.) in the product sterility testing is the essential method. As this testing is very important, it…
RAPID METHODS FOR STERILITY TESTING
Current compendial methods for sterility testing in the pharmaceutical industry remain culture-based and include an incubation period of 14 days. Clearly, this is a delay…
TEST FOR BACTERIAL ENDOTOXINS
The bacterial endotoxins test (BET) is a test to detect or quantify endotoxins from Gram-negative bacteria using amoebocyte lysate from the horseshoe crab (Limulus polyphemus…
QUALITY CONTROL & EVALUATION OF PHARMACEUTICAL AEROSOLS
QUALITY CONTROL TESTS:- It includes the testing of:- Propellents Valves, Actuator, Dip Tubes Containers Weight Checking Leak Testing Spray Testing Propellents:- All Propellents are…
ELEMENT IMPURITIES CLASSIFICATION
Elemental impurities in drug products may arise from several sources; they may be added intentionally in synthesis, or may be present as contaminants (e.g., through…
PROCESS VALIDATION: GENERAL PRINCIPLES AND PRACTICES
General Considerations for Process Validation: – In all stages of the product lifecycle, good project management and good archiving that capture scientific knowledge will make…
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