In regards to the life sciences industry, the FDA ( www.fda.gov ) is responsible for protecting the public health by assuring the safety, efficacy, and security of human drugs, biological products, and medical devices. Regulations, collectively known as the GxPs (Good x Practices), have been enacted to govern the development, testing, and manufacturing of drugs, medical devices, and biologics.
The GxPs are broken down into:
- Good Laboratory Practices (GLPs) : apply to the non-clinical studies in the evaluation of a new drug, medical device, or biologic product.
- Good Clinical Practices (GCPs) : apply to the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
- Good Manufacturing Practices (cGMPs) : apply to the manufacture, testing, and distribution of a new drug, medical device, or biologic for human or veterinary use.
GLPs
The FDA established regulations regarding Good Laboratory Practice (GLP), 21 CFR Part 58, in 1979, in response to fraud discovered at a U.S. toxicology lab. As described in Part I of the GLPs:
“The regulations establish standards for the conduct and reporting of nonclinical laboratory studies and are intended to assure the quality and integrity of safety data submitted to FDA. … FDA relies on documented adherence to GLP requirements by nonclinical laboratories in judging the acceptability of safety data submitted in support of research and/or marketing permits.”
GCPs
The International Conference on Harmonization (ICH) ( www.ich.org ), defines GCP as "Good Clinical Practice", which is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. FDA and other international and country-specific GCP regulations, guidelines, and standards are thus designed to provide assurances regarding clinical trial subjects and data.
cGMPs
Life science manufacturers, packagers and distributors of drugs, and medical devices, must take proactive steps to ensure that their products are safe and effective, thus adhering to cGMPs. The language used in the cGMP regulations are both broad and subjective, and it requires companies to be flexible in interpreting and implementing meaningful methods of compliance. In order to compete in today's market, companies must find innovative ways to make and deliver their products while maintaining regulatory compliance.
How AQS Can Help
AQS' consultants assist companies in understanding and interpreting key regulatory concepts and have extensive experience and knowledge of industry best practices, used in the implementation and validation of systems. By taking a business-driven, risk-based approach to the implementation and validation of computer systems used in the drug development life cycle, AQS helps you focus your efforts on those areas and activities where the greatest value will be realized. This approach begins with identifying, evaluating, and documenting the business and regulatory challenges faced by the area in question.
AQS works with your business as an independent resource or as a member of your team, ensuring knowledge-sharing is a component of the end product.
Our experts will guide you through the regulatory issues and ensure your systems or programs are implemented using proven, practical, industry best approaches, regardless of the size of the project.
AQS' Expertise
- Compliance Plan Development
|
|
- System Inventory Development
|
- System Compliance Strategy
|
- Business and Regulatory Risk Assessment
|
- Execution of Technical and Procedural Remediation Activities
|
- Implementation of Compliant Systems
|
|
