Analytics

The use of quality management software (QMS) to automate manufacturing quality processes quickly is becoming an industry-wide initiative. Companies are turning to commercial off-the-shelf systems (COTS) to simplify implementation and validation efforts. Regardless of the system selected, the automation of these critical quality processes is subject to electronic records and electronic signatures (ER/ES) requirements, as set forth in the 21 CFR Part 11 regulation (1). Therefore, companies must adopt a comprehensive but manageable approach to Part 11 compliance as they begin to automate the processes that support product quality and efficacy to ensure they meet the requirements of good manufacturing practices and all predicate rules.

New Chemical Reaction Method Accelerates Indole Production

A newly developed software program transforms written SOPs for all required analytical method validation experiments into transferable automated templates, integrating individual activities and technologies under one platform.

Asieve or screener is an essential part of every pharmaceutical production process, particularly as product quality and integrity are so important. The use of a sieve gets rid of oversized contamination to ensure that ingredients and finished products are quality assured during production and before use or despatch.

The FDA initiative —Process Analytical Technologies (PAT) — is slowly gaining momentum, creating a revolution in manufacturing and testing processes that aims to ensure product quality. Its growth will encourage faster testing techniques to bring analytical testing closer to on- and at-line testing during the product manufacturing process.

Active pharmaceutical ingredients (APIs) have become more potent, therefore the requirements of good manufacturing practice (GMP) are making ever more stringent demands on valve design and sealing. An absence of dead space, ease of cleaning and flushing is the norm for valves where cross contamination must be avoided at all costs. Sealing valves to glass reaction vessels has lagged behind valve sealing for steel vessels.

The authors propose a strategy for classifying and validating inprocess testing methods.

The author proposes a new analytical graphic, the sector chart, which presents data that cannot be adequately presented with current graphs.This chart combines features of zone charts with the basic principle of precontrol charts. It addresses engineering control and is superior for representing data such as beneficial and adverse trends.

The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results.To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the pparent number in the sample.

The C-SOC team must develop a network of committed industrial partners who will participate in the direction, execution, and evaluation of research and educational activities.

X-ray microtomography has great potential for improving the understanding of the structural features of solid dosage forms and the changes in those features during manufacturing, handling, and storage.This article describes the basic principles of the technique and provides examples of its potential applications.

A comparative study of three air samplers used for bioaerosol collection was performed to evaluate the average recovery of colony-forming units and assess the precision of each device.

Nanotechnology is believed to hold enormous promise for the future of medicine and healthcare...

A comparative study of three air samplers used for bioaerosol collection was performed to evaluate the average recovery of colony-forming units and to assess the precision of each device.

Nanostructured lipid carriers are a new type of delivery system offering improved performance in terms of drug loading and long-term stability with the ability to form highly concentrated dispersions...

X-ray microtomography has great potential for improving the understanding of the structural features of solid dosage forms and the changes in those features during manufacturing, handling, and storage. This article describes the basic principles of the technique and provides examples of its potential applications.

The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results. To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the apparent number in the sample.

In this article, the author explains some of the technology behind using ion-exchange resins for drug delivery...

As newer and more elaborate hardware and software systems are installed in automated manufacturing environments, companies are further incorporating good practices into their validation process.

The author describes strategies for analytical method development that are helpful in achieving quality by design and efficiency.

The Impurity Profiling Group reviews stress testing according to regulatory guidance documents. The authors emphasize what should be considered for late clinical phases and for registration application dossiers.

Pharmaceutical Science & Technology Innovations

Analytical instrument suppliers are developing manufacturing-tailored tools that are small, precise, and easy to use.

The United States Pharmacopeia should not change its philosophical position on singlet testing.

A swab-sampling method was developed for cleaning validation of a residual active pharmaceutical ingredient in samples collected after cleaning the sampling suite. A summary of the strategies and results of the method development is presented.

Comparative studies of the US Pharmacopeia (645) "Conductivity" and the European Pharmacopeia "Heavy Metals" tests were conducted to demonstrate that the USP method can determine the presence or absence of heavy metals in process water samples.

Pharmaceutical Science & Technology Innovations

Laser diffraction is an important technique for particle size analysis. This article highlights the many advantages this tool has to offer.

Pat Survey

This article provides guidance for developing dissolution testing for poorly soluble compounds. It is the second of a series of articles based on material from a 2003 PhRMA workshop about acceptable analytical practices.