Quality Assurance Articles

Part 1 of this article discussed the unique properties of the water molecule. It discussed the five basic groups of contaminants found in water, which are particles, dissolved salts, organics, colloids, and bacteria. Part 1 also provided the reader with an understanding of the importance of water supplies in determining the types of contaminants expected in the water. Part 2 of this article describes the processes used to remove contaminants from a water supply, integrating components into a functional system, and the importance of controls and routine periodic water testing.

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Bringing a drug product to market requires that all parts of the manufacturing and validation puzzle comply with an increasing number of regulations. Managing the quality aspects for far-flung organizations can be a colossal assignment. A quality assurance unit may be the answer you need, along with finding capable, competent people and ensuring that they have the right communication tools.

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Identifying and setting specifications to establish the quality dimensions of a drug substance represents an important aspect of project management. With significant cost and time-to-market pressures, a well thought out strategy regarding a product’s specifications can have huge implications o­n ease of manufacturing and, ultimately, o­n the product’s financial return. The cost of measuring numerous specifications o­n a commercial product is significant. An evolving specification “laundry list” generated during the development process may become “engraved in stone,” incurring unnecessary costs year after year during the product’s life cycle. Surely, this is an undesired situation in today’s cost-conscious marketplace. Therefore, an important project management goal is to establish material acceptance specifications that clearly assess the API’s quality as it is released from a validated manufacturing process.

the International Pharmaceutical Excipients Council (IPEC) updated its 1995 Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients to incorporate ISO 9000:2000 requirements.Recently, the Institute of Quality Assurance/ Pharmaceutical Quality Group (IQA/PQG) proposed the pharmaceutical excipients application standard PS 9000:2002, which introduces three levels of increasingly stringent quality system requirements. However, the author argues that the additional set of GMP requirements is not necessary and, in fact,will result o­nly in increased complexity for excipient manufacturers.

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A procedures system must be well designed and managed to be effective and efficient.For full article click here

Pure water is becoming more important to an increasing number of businesses. More and more contaminants are being found in water supplies, making water purification more difficult and complex. Many industries, particularly the semiconductor, power generation, and pharmaceutical industries, are demanding water with greater levels of purity than ever before.As a result, there is an increasing need for plumbing engineers to be able to properly design water purification systems. Prior to doing this, we all need to understand the nature of the contaminants, or undesirable materials, found in water. We also will learn that the source of the water and the treatment done o­n a municipal level will determine how difficult a given water source is to purify.

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Six months into its initiative to update manufacturing regulations, FDA announces a raft of changes covering warning letters, inspections, and comparability — plus a fresh start o­n Part 11.

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Because of its importance, the QA team should report to the highest level of management and maintain independence.

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a pharmaceutical company moves its therapeutic products through clinical trials, its identity changes. In the early phases of drug development, quality is important, but it takes a back seat to process development and clinical trials. Although the company recognizes its future potential as a GMP firm, various financial and strategic constraints often delay management from beginning large-scale investment in facilities and headcount.When management finally gives the go-ahead to prepare for large-scale production late in Phase II trials, all units of the organization race frantically to redefine themselves or build themselves from scratch to adapt to inevitable changes in the company’s focus. GCPs and GLPs are no longer adequate for the work ahead, and the outsourcing relationship that supplied the clinical trial material cannot sustain market levels.

This article discusses the advantages of manufacturing execution systems and the challenges involved in their implementation and validation.


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