Regulatory Oversight

Technology's new monthly "Agent-in-Place" column distills true-life cautionary tales from the secret files of Control, a senior compliance officer.

New Guidance May Speed Generic Approvals

The European Commission has released its second report to the Council and European Parliament addressing the developments and implications in patent law concerning biotechnology and genetic engineering. The study, which centres on the patentability of inventions relating to stem cells, concluded that those capable of developing into human beings, totipotent stem cells, are to be excluded from patentability on the Directives' grounds of human dignity.

Our GMP Agent-in-Place at a top-10 pharmaceutical manufacturing firm reports on a spill during the manufacture of a time-release capsule filled with coated beads.

In 1987, when the US Food and Drug Administration issued its Guideline on General Principles of Process Validation, a young FDA reviewer asked her supervisors.

The question of pharmaceutical pricing is going to be resurrected by the European Commission, despite French President Jacques Chirac's rejection of the new EU treaty. Günther Verheugen, the Commission vice president, made this announcement at the annual meeting of the European Federation of Pharmaceutical Industries and Associates in Brussels (Belgium) responsible for competitiveness.

Reading the good automated manufacturing practice (GAMP 4) guide acquaints you with the now classic and almost famous V-model.1 The V-model, originally used for describing a validation workflow of IT and automated systems, is easy to understand and very good at ensuring that the requirements and design are built into the final solution. It is also extremely versatile and can be used for almost any type of validation task you could meet in a development phase.

New Excipient Guidance Doesn?t Fill Regulatory Gap

Managers of FDA-regulated firms must be proactive in how they manage their company?s compliance with good manufacturing practices regulations.

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.

FDA Finalizes Guidances on Minimizing Drug Risk and Submitting Pharmacogenomic Data

CBER Draft Guidance for Spore-Formers and Plasmid Vaccines

Defenders of the research-based industry are hoping for an early Christmas present from the European Court of Justice (ECJ). All the signs are that a small but significant victory is on the way against parallel importing. Right at the end of October, a senior judge responsible for a leading case at the court made clear his view that international drug firms do not necessarily have to make life easy for parallel importers. The formal ruling on the case at issue is expected within weeks.

This article provides guidance for minimally acceptable method validation practices and a foundation for assessing the risks and benefits associated with method validation programs.

Phase II of FDA's GMP modernization plan may involve revising regulations to fit new policies and inspection and review programs.

The implementation of a total organic carbon (TOC) method into the United States Pharmacopeia (USP) has its origins in the early 1990s, when the Water Quality Committee (WQC) of the Pharmaceutical Manufacturers Association (PMA, later renamed PhRMA) debated improvements in the testing of purified water (PW) and water-for-injection (WFI). The resulting inclusion of modern analytical techniques replaced much older methods - some of which had been listed in the USP for more than 150 years. Finally, two new regulations were put in place: Chapter for conductivity, which replaced a series of individual ion tests; and Chapter which replaced the oxidizable substances test with a TOC method.

Evaluations have shown, in most cases, visual observations are sensitive enough to verify equipment cleanliness. An experiment was conducted to explore the possibility of using a visible-residue limit as an acceptable cleaning limit in a pharmaceutical research facility, including an evaluation of the limits and subjectivity of ?visually clean? equipment.

This article discusses the basics of sterile filter qualification and validation, with emphasis on bacterial challenge protocol development and testing. Reference is made to Technical Report no. 26 of the Parenteral Drug Association.

FDA's recently released initiative has made process analytical technology (PAT) a hot topic in the life science industry. PAT describes the application of process analytical chemistry tools, feedback process control, information management tools, and product and process optimization strategies for the development and manufacture of pharmaceuticals. In this article, the author explores the impact PAT will have on the pharmaceutical industry.

Customers are placing high demands on pharmaceutical manufacturers to produce sensitive, cost-effective and regulatory compliant inspection technology. This article examines how metal detection equipment suppliers can combine forces with manufacturers to provide state-of-the-art inspection systems, giving particular consideration to cleaning processes and regulatory issues.

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.

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 ....

As FDA prepares for the Critical Path initiative, offices across the agency are expanding the use of the risk-based approach to regulation and applying a quality systems approach to internal operations.

From data acquisition to enterprise resource planning, software systems operating at all levels of pharmaceutical manufacturing prepare for the seemingly inevitable implementation of process anlytical technology.

Total organic carbon (TOC) analysis is a fast and effective analytical technique for cleaning validation. Understanding the various types of TOC technologies is essential for choosing the best solution.

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.

Following the launch of its initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," FDA has been looking to process analytical technology (PAT) for improvements in process efficiency and quality. This article discusses the implementation of PAT systems into production environments, its impact on quality assurance and the necessity of an integrated approach. Options for implementing PAT are also presented.

This article examines European differences in GMP requirements for the acceptance of Certificates of Tests. The authors look at how pharmaceutical manufacturers can address the issues and suggest a US-compatible framework for GMPs that could be incorporated into EU requirements.

FDA is expanding electronic data submission programmes to improve regulatory operations, and ensure appropriate and safe drug use.