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HVAC SYSTEM VALIDATION TESTS

AIR FLOW PATTERN:- For determination of air flow pattern, a titanium tetrachloride stick is burnt and placed in front of the AHU. The distribution of smoke is observed. It should be uniform.   AIR...

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...

WHO GUIDELINE FOR SAMPLING OF PHARMACEUTICAL PRODUCTS

SAMPLING: - Sampling comprises the operations designed to select a portion of a pharmaceutical product for a defined purpose. The sampling procedure should be appropriate to the purpose of sampling, to the type 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...

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