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REVIEW - QUALITY CONTROL OF PARENTERAL PRODUCTS

In a pharmaceutical organization a quality control is a fundamental segment that refers to a process of striving to produce a product by a series of measures requiring an organized effort by entire company to eliminate or prevent error at any stage of production. Quality control deals with testing, sampling, specification, documentation, release procedure which ensure that all tests are actually carried out prior to release of material for sale or use. Until its quality judged to satisfactory....

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Excipients in parenteral formulations: selection considerations and effective utilization with small molecules and biologics

Abstract

Excipients form a major component of pharmaceutical formulations and are classified as any ingredient other than the active ingredient which is included within the product formulation to improve drug product performance.

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Hot Read: GMP in Practice

July, the fifth edition of the PDA/DHI book,GMP in Practice:Regulatory Expectations for the Pharmaceutical Industry was published. The PDA Letter interviewed authors Tim Sandle and James Vesper about this bestselling book, which can be purchased in the PDA Bookstore....

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Endotoxin Testing Using Recombinant Reagents

Bacterial endotoxin testing occurs at all stages of sterile pharma manufacturing, from raw materials to semifinished and final product. This ensures safe production of injectables and medical devices. Mandated by regulators, endotoxin control is important for two main reasons: First, endotoxins are known to cause strong human immune-system reactions, including fever, and can proceed to Gram-negative bacterial sepsis . Second, even trace amounts of endotoxin may interfere with the immune response of medical drugs, potentially altering their therapeutic effects.... 

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The Cost of Microbial Control

Microbial contamination control remains a critical focus for the pharmaceutical industry. Microbial controls can be found throughout the manufacturing process including, but not limited to, raw materials, equipment, cleanroom environments, finished product manufacturing, and storage and shipping processes. Bioburden control programs are also essential for both sterile and nonsterile manufacturing. Many similarities exist between bioburden control and contamination control—in fact, the terms are frequently used interchangeably—however, the differences can result in ineffective or excessive control programs for sterile and nonsterile products....

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