SOP FOR DEPYROGENATION
1.0 OBJECTIVE : This procedure is laid down for depyrogenation of glass wares for Bacterial Endotoxin test to make them free from any endotoxin and…
Tag: pharma articles
DRUG REGULATORY AFFAIRS AND ITS COMMON TERMINOLOGIES
Regulatory Affairs:- Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across…
GUIDELINE ON RECALL
Introduction:- Recall is an action taken to withdraw/remove the drugs from distribution or use including corrective action for which deficiencies are reported in quality, efficacy…
DISINTEGRATION TEST FOR TABLETS AND CAPSULES
DISINTEGRATION TEST:- This test is provided to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium under the…
QUALIFICATION OF AUTOCLAVE
AUTOCLAVE: – An autoclave is a pressure chamber used to carry out industrial processes requiring elevated temperature and pressure different to ambient air pressure. Autoclave…
LIMIT TESTS
LIMIT TEST FOR CHLORIDES Apparatus Required Nessler cylinders Glass rod Stand Chemicals Required Dilute Nitric acid (10%) Silver nitrate (5%) Sodium chloride Principle It is…
ALCOA IN PHARMA INDUSTRY
The acronym ALCOA is used by regulated industries as a framework for ensuring data integrity, and is key to Good Documentation Practice (GDP). ALCOA relates…
DIFFERENCE BETWEEN SCADA, PLC AND HMI SYSTEM USED IN PHARMA INDUSTRY
SUPERVISORY CONTROL AND DATA ACQUISITION (SCADA) – It is an integrated system that is used to control and monitor the working of the individual parts…
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