Regulatory/GMP Compliance

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.

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.

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.

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.

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.

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.