Frequently Ask Questions about FDA Regulations Compliance

General principles and practices.

Essential document. Arguably the most notable "must read" for understanding Good Manufacturing Practices. more

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Frequently Asked Questions

"The GxPs". What does that mean?

"The GxPs" is using the term to take into account all current best practices and their predicate rules.  The GxPs include (partial list):
o Current Good Clinical Practices (cGCP)
o Current Good Laboratory Practices (cGLP)
o Current Good Manufacturing Practices (cGMP)

What is GMP training and how does it apply to FDA regulations compliance?

GMP (also known as cGMP) stands for "current Good Manufacturing Practice". The FDA regulates the manufacture of Pharmaceuticals, Medical Devices, Human Foods, Laboratory Practices and various other aspects of how products are developed, manufactured, and distributed. Therefore, mandatory GMP training and proper documentation is key to providing facilitates the ability to adhere to FDA regulations.

What is validation? What is the difference between validation and qualification?

A [good] definition of validation: "An on-going process to establish documented, objective evidence which provides a high degree of assurance that a system will consistently meet its predetermined specifications, and will perform repeatedly as intended." Verification, on the other hand, is a Quality control process that is used to evaluate whether or not a product, service, or system complies with regulations, specifications, or conditions imposed at the start of a development phase. Verification can be in development, scale-up, or production. This is often an internal process. Validation is a Quality assurance process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance of fitness for purpose with end users and other product stakeholders.

The validation master plan is the foundation for a validation program at an organization and includes, but is not limited to, the documentation for defining the following: Process validation Facility and utility qualification and validation Equipment qualification Cleaning protocols Computer validation Software development life cycle (SDLC) .

Simple - the possibility of going paperless. However, having training records stored in a computerized system requires the system to be validated per 21 CFR Part 11.  The cost saved is associated with the cost of ongoing validation and the acquisition of approved storage - multiple (depending on your company's size) fire and smoke per vault, for example.

Last, but not least: an important reminder regarding Online GMP Training and FDA Regulations Compliance. CFRs and industry guidelines represent a minimum set of requirements for the industry to follow in order to produce a reliable and reproducible product or service throughout the product development lifecycle - so GMP training is key! Start preparing yourself for your responsibilities by taking online GMP training courses, and keep your training record up to date! Don't forget about our Free FDA Regulations Information Library!

The information is educational purposes, however some documents may be marketing pieces or white papers from companies for a commercial product. We do not endorse or condone the use of any products mentioned in documents, nor do we take credit for writing any of these documents - we just put it all together for your convenience.

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