Validation Articles

A contract manufacturer used seven analytical methods while developing an early-phase protein therapeutic in six short months.Demand for parenteral-dose contract manufacturing services is on the rise, fueled in part by strong growth in the number of biologics in the approval process

Constraints associated with equipment can make scale-down a challenging exercise Creation and qualification of scale-down models is essential for performing several critical activities that support process validation and commercial manufacturing.

This combined article is the fifth in the "Elements of Biopharmaceutical Production" series. Part 1 (March 2005) covered fermentation. In this segment, we present some guidelines and examples for scale-down of common downstream unit operations used in biotech processes — chromatography and filtration.

Outsourcing is becoming increasingly widespread and essential in the biopharmaceutical industry. Its imprint on biotech world business and on the development of biopharmaceutical drugs is becoming ever more pronounced. It is estimated that almost one-half of biopharmaceutical companies contract out at least part of the production of their products.

RFID technology is one of the most promising approaches to reliably authenticate, track, and trace bio-pharmaceutical products. Pharmaceutical organizations, including the biopharm segment, have repeatedly learned that their very existence rides on safety concerns.

Tracking products through the supply chain, from the shipping dock to the medicine cabinet would be desirable. There are good reasons to believe that radio frequency identification (RFID) technology is one of the most promising approaches to reliably authenticate, track, and trace pharmaceutical products. We will cover three aspects of RFID solutions in this article: the drivers for adopting RFID, the state of adoption, and technology options. We will show that RFID can mitigate enterprise risk through tighter counterfeit and diversion controls, ensure compliance with electronic pedigree tracking and reporting requirements, and enable more efficient recalls.

The author continues his discussion of the principles involved in the backup and recovery of electronic records. This installment looks at the written procedures associated with this process for a spectrometer operating in a regulated laboratory Although this column discusses regulatory requirements and issues, it is important not to forget that the main reason for backing up your application and data is a business one. You'll install your software and then configure the system by defining items such as authorised users, user types, access control privileges, user-defined macros, libraries, and so forth. Imagine the problem if your computer hard disk fails and you have no effective backup.

Few people really understand how software works, but everyone notices when it doesn’t, especially when these systems contain the data that will be used to determine product quality and ensure regulatory compliance. Industrial-scale software implementation is a considerable investment, and the technology that drives it advances quickly. Thus, it was not surprising that when FDA announced its support of the process analytical technology (PAT) approach to pharmaceutical manufacturing, questions arose about how current software systems would have to be modified.

View Full Article

This article presents a top–down approach to properly implementing a validation project for electronic spreadsheets. The article provides some interesting historical background about the evaluation of electronic spreadsheets and uses Microsoft Excel as the base spreadsheet application because it is widely used as such. The article discusses the shortcomings of electronic spreadsheets and highlights some unique solutions and techniques to help pharmaceutical companies comply with 21 CFR Part 11. The validation approach proposed herein is based on the good automated manufacturing practice (GAMP) methodology but also incorporates specific technical test cases and considerations that are unique to the qualification of spreadsheets to fully comply with the predicate regulations and 21 CFR Part 11.

View Full Article

Imagine that you have just finished authoring a validation protocol. You electronically sign the document and sequentially email it to the various approvers who also electronically sign it and return it to you. After opening your last e-mail with the completely approved file, you send a copy of the file to the document-control server for archival, download another copy onto your tablet portable computer (using a wireless Ethernet connection), and proceed to the field where you begin to execute the protocol by typing right into the file

View `

Part I of this article was published in the September issue of Pharmaceutical Technology and provided an update of the validation of moist heat sterilization, reviewing the the sterility concept, sterilization principles, development of sterilization cycles, and the measurement of sterilization efficiency. Part II discusses the qualification–validation procedure and the probability of nonsterility of a load during the validation of the steam sterilization process.

View Full Article

Most people know that developing new drugs requires an enormous amount of time and money. On average,introducing a new drug product to market takes approximately 15 years and $650 million. A drug product consists of therapeutics and excipients combined in a delivery system. A drug product’s success lies in its ability to deliver the drug at a certain rate in a certain environment in the body. This is a function not only of the drug’s chemical and physical attributes but also the patient’s metabolism. Thus, one of the main challenges to  harmaceutical scientists and engineers is the interplay of drug discovery, effective drug delivery, and efficient production of drug products.

View Full Article