Data and Artificial Intelligence

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Pharmaceutical Science & Technology Innovations

Pharmaceutical Science & Technology News

Information retrieval (IR) deals the representation, storage, organization of unstructured applying natural-language processing,semantic relationships, linguistic analyses,behavioral histories, and “fuzzy” statistical techniques to help human quickly find and retrieve the information they seek.

This article describes a novel approach to a scale-up management system, based on a holistic view of the scale-up lifecycle and an accompanying electronic development record of the information created.

The author argues that information technology solutions will play a major part in confirming-by experimental and statistical validation-that bioprocesses may be interchangeable and therefore generic. The bioprocessing ANDA will define both in-house and contract manufacturing.

Excel File

Emerging high-tech solutions prepare to cater to industrial automation with promises of increased efficiencies, faster communications, and custom applications.

Most, if not all, pharmaceutical companies today are moving towards a paperless reporting structure. This article examines FDA's 21 CFR Part 11 regulations, which relate to technical and procedural compliance for electronic records and signatures.

Resolving the asset headache - the author explains how effective asset management can enable pharmaceutical companies to boost operational profit, increase production uptime and adhere to regulatory standards.

If an inspection reveals any shortcomings ... a manufacturer may be warned, fined, or its facility closed down until full control can be demonstrated to the satisfaction of the authorities ....

Pharmaceutical Science & Technology News

Pharmaceutical Science & Technology Innovations

pharmaceutical science and technology innovations

Pharmaceutical Science & Technology Innovations

Pharmaceutical science and technology innovations

Pharmaceutical Science & Technology News

FDA expects a firm that is subject to GxP to develop a risk evaluation of its product and to then mitigate the identified risks. Identified risks may be addressed by technical fixes that effectively eliminate the risks or reduce the likelihood of occurrence and/or severity of consequences to acceptable levels.

When implementing computerized systems, it is important that both purchasers and vendors ensure that each stage of the process (from planning through operation to modifying) is properly validated. This article looks at some of the issues that arise when switching from traditional document-based procedures, and at the benefits that computerized systems can bring.

The importance of calibrating instruments used in manufacturing processes is well known, particularly for highly regulated industries such as pharmaceutical production. This article discusses software applications used to support calibration management, and the potential economic gain to be had by replacing a standalone software application with a capable enterprise system.

This case study examines the benefits of introducing process information management software to a pharmaceutical pilot plant. The advantages illustrate the potential for process development and commercial manufacturing improvements that are available to the pharmaceutical industry.

With the advent of regulations such as 21 CFR Part 11 and the introduction of the electronic common technical document, it is becoming increasingly important to be able to enhance and fully utilize data management systems. Document change management is a vital tool in the construction and organization of valuable information, and can play a key role in the all-important process of getting a product to market.

Until specific audit trail requirements are available from the US Food and Drug Administration, manufacturers must define their own parameters for software system compliance and decide for themselves how to meet those requirements.

More than 6 years have elapsed since the US Food and Drug Administration's (FDA's) 21 CFR Part 11 regulations regarding the use of electronic records and electronic signatures came into effect.1 In February 2003, FDA issued new draft guidance concerning the scope and application of Part 11, which describes how the agency intends to interpret and enforce the requirements during its ongoing re-examination of the regulations.2 Many people in the pharmaceutical industry have welcomed this new guidance and see it as a positive development that will lead to a simplified FDA approach to Part 11 and a significant reduction in the industry's compliance burden.

Paper batch records have been used for decades to record procedures, the type and quantity of each material used, and the status of each step in the manufacturing process for both pharmaceuticals and medical devices. Although paper batch records are less complicated to implement than their electronic counterparts, and the controls required for data recording and archival are well understood, a paper batch record system is laborious to maintain and prone to human error, which increases the compliance risk. Additionally, batch records have become bulky and more time consuming to prepare and review, particularly as manufacturing operations become increasingly complicated. Advances in technology and science have created a more competitive climate in life science industries than ever before, causing the need for manufacturers to reduce costs and time-to-market, and improve their ability to satisfy the compliance requirements of US Food and Drug Administration (FDA) regulations. The use of electronic batch recording systems (EBRS) and electronic batch records (EBR) offers one solution.