Sterile products are very critical and sensitive in nature need very high degree of precautions, prevention and preparations and needed. Dampness, dirt and darkness are…
**To achieve the objectives listed below, each licensee shall evolve appropriate methodology, systems and procedures which shall be documented and maintained for inspection and reference;…
GMP:- GMPs define a quality system that manufacturers use as they build quality into their products. For example, approved drug products developed and produced…
Definition of Six Sigma:- Six Sigma is a smarter way to manage business or department. It is a vision of quality that equates with only…
IDENTIFYING AND ASSESSING OOS TEST RESULTS:- FDA regulations require that an investigation be conducted whenever an OOS test result is obtained. The purpose of the…
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…
All filled aerosol cans are leak tested before distribution to prevent an empty or near-empty product from reaching the patient. Four methods are currently used…
INTRODUCTION: – In pharmaceutical industry it is vital that package selected preserve the integrity of product. The selection of package begins with determination of products…
Class I:- A cabinet with a front aperture through which the operator can carry out manipulations inside the cabinet. This type of cabinet is suitable…
Basket Apparatus (USP Apparatus 1): – The basket method was first described in 1968 by Pernarowski, Woo, and Searl. A container, the basket, constrained the…
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