GMP

Differences between Good Laboratory Practice (GLP) & Good Manufacturing Practice (GMP) Laboratory Testing Regulations

People are often confused by differences between Good Laboratory Practice (GLP) regulations and Good Manufacturing Practice (GMP) regulations as they relate to laboratory testing. This is understandable, since both GLPs and GMPs cover lab testing but are very different. In addition, scientists and quality control/quality assurance personnel participating in GLP and GMP studies play different roles. GLP […]

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Pharmaceutical Microbiology, , , ,

RULES OF GOOD MANUFACTURING PRACTICE (GMP)

GMP encompasses the rules governing the manufacture of a safe and efficacious pharmaceutical product, drug or food.  And it is critical that the personnel working in pharmaceutical and food companies abide by these rules to ensure quality and safety during and after production. Personnel working in pharmaceutical and/or food companies where drugs and food are

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Pharmaceutical Microbiology, , ,

CRITICAL ASPECTS OF GMP (sources of microbial contamination)

Some of the main sources of contamination in the course of production in a food or pharmaceutical company, and the areas of good manufacturing practice (GMP) that centers on controlling all possible sources of microbial contamination of pharmaceutical and/or food products during manufacturing include but not limited to the control of air, raw materials, water,

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Pharmaceutical Microbiology, , , ,

PRINCIPLES OF GOOD MANUFACTURING PRACTICE (GMP)

GMP guidelines are not prescriptive instructions on how to manufacture any product including food, drugs, and other pharmaceutical products. Rather, the GMPs are a series of general principles that must be observed during the manufacturing of pharmaceuticals, drugs and food in order to ensure that only products of high quality and one which is free

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Pharmaceutical Microbiology, ,

GOOD MANUFACTURING PRACTICE (GMP)

Good manufacturing practice (GMP) is simply defined as those general rules that govern the manufacture and/or production of a safe, efficacious and microbial-free pharmaceutical product. GMP are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, and quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients,

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Pharmaceutical Microbiology, , , , ,

QUALITY ASSURANCE

Quality assurance (QA) is a planned and systematic process used for evaluating and monitoring the quality and appropriateness or suitability of a product or given service. QA is related but different from quality control (QC). It is mainly geared towards finding a problem that is associated with a given product and managing it so that

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Environmental & Soil Microbiology, Food Microbiology, Pharmaceutical Microbiology, , , ,

QUALITY CONTROL

Quality control (QC) is defined as a monitoring system that is used for detecting and correcting analytical errors by establishing performance limits. QC is a procedure or set of procedures intended to ensure that a manufactured product including pharmaceutical and medical products or performed services adheres to a defined set of quality criteria or meets

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Environmental & Soil Microbiology, Food Microbiology, Pharmaceutical Microbiology, , , ,

PYROGEN TEST

A pyrogen is simply defined as a fever-causing (inducing) agent that includes toxins of microorganisms. The phrase “pyrogens” is derived from the Greek word “Pyros” to mean “Fire”. Pyrogens are the lipopolysaccharide (LPS) component or endotoxins of bacteria especially Gram negative organisms. They also include the cell wall components of both Gram negative and Gram

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Food Microbiology, Pharmaceutical Microbiology, , , , , , , , , , , ,