Quality/GMPs

The FDA?s risk-based approach to pharmaceutical cGMPs applies to 21 CFR Part 11 enforcement as well. Understanding different methodologies for assessing and managing risk will help you develop and begin to implement a compliance plan.

Protecting the integrity of data is a challenge of 21 CFR Part 11 compliance. Integrity requires records to be complete, intact, and maintained in their original context ? associated with the procedures which were used to create the data.

Bringing different laboratory instruments into compliance takes planning. The key strengths and weaknesses of different levels of control and feedback for analytical instruments and data transfer systems are highlighted in this article.

This article focuses on the front end of qualifying a new raw material from a given supplier. Once qualified, this status must be maintained by periodic review and requalification.

Operational planning and early cost analyses are key to generating optimal, robust, and economical commercial processes.

Canada's biotechnology industry has expanded rapidly in the last decade, as measured by industry-wide revenues, the launch of new companies, and the continuous diversification of its products.

There are pressures on biopharma to grow up — and to grow up fast. Although we still hear references to its "infancy," I think we're well past that stage and already confronting the awkward — and sometimes painful — experience of adolescence.

Quality assurance units are interwoven throughout the biopharmaceutical enterprise and provide support to sustain operations. Most importantly, they must have the capacity and leadership to adapt to change.

In September 2003, Sweden's biotechnology sector recorded a striking achievement. Amgen, the world's largest biotechnology company, announced plans to acquire exclusive rights to Biovitrum's small-molecule enzyme inhibitors for the treatment of metabolic diseases.

Molecular mimicry is a common, but undesirable, property of disease proteins. Sequence similarities between cancer proteins and self-proteins allow tumor cells to hide, thereby avoiding attack from the immune system. HIV uses the same evasive tactic.

Training programs do not have to be complex to be successful. There are basic elements, however, that all must have to meet FDA requirements and ensure that employees have the knowledge and skills to maintain high quality standards.

FDA initiatives aim to spur development of more affordable treatments and ensure safe product use.

Helium Out-Detects Soap and Water

Biotech companies are among the most intensive instrumentation users of any FDA-regulated business. Because of the complex nature of these companies' research and manufacturing, they typically have a larger number of instruments per employee.

When developing a strategy for using technology in biopharmaceutical manufacturing, include the interaction between automation and business systems and the roles they play in enhancing quality assurance and compliance.

Process characterization requires a significant commitment of time and resources, but the payoff is better process understanding, improved manufacturing success rates, and avoidance of costly regulatory delays.

Good laboratory practice is the central dogma of all laboratory research and investigation - it's your commitment to regulators - and poor laboratory controls are a common cause of 483 observations and preapproval inspection failures.

BioPharm International and Tefen Ltd. have teamed up to provide you with information and tools from the BioPharma Operations Excellence Consortium.

Supplementing your existing staff with experienced contractors when your process is ready for validation can help you avoid common validation mishaps - if you know the ingredients of successful project management.

In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.

A successful outcome to an FDA inspection is the fruit of planning, preparing, and training. Cultivate confident employees who are appropriately coached and clear about their responsibilities.

FDA efforts to encourage generic drug approvals and to consolidate oversight for biotech therapies could open the door to biotech equivalents