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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 hence to avoid any false positive results. 2.0 SCOPE :...

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 the world. It is mainly involved in the registration...

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 or safety. The defective products related to quality includes...

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 experimental conditions stated below. APPARATUS:- The apparatus consists of a...

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 are used in medical application to perform sterilization, and...

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 based upon the chemical reaction between silver nitrate and soluble chlorides in presence of...

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 to data, whether paper or electronic, and is defined...

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 of the plant. It helps in management of automation...

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