According to the US FDA mission statement (www.fda.gov), "The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health." 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): Regulations that apply to the non-clinical studies in the evaluation of a new drug, medical device, or biologic product.
Good Clinical Practices (GCPs)::Regulations that apply to the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
Good Manufacturing Practices (cGMPs):: Regulations that apply to the manufacture, testing, and distribution of a new drug, medical device, or biologic for human or veterinary use.
GLPs
In 1979, FDA established regulations regarding GLP, 21 CFR Part 58, in response to fraud discovered at a toxicology lab responsible at the time for about 40% of the safety testing of food additives, pesticides and drugs in the US. 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."
Other international and local regulatory agencies and organizations have adopted similar standards. The Organisation for Economic Co-operation and Development (OECD), defines GLP as:
"...a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported."
Even as newer regulations such as 21 CFR Part 11 (Electronic Records; Electronic Signatures) and new guidances like "Pharmaceutical cGMPs For The 21st Century - A Risk-Based Approach," have been issued by FDA and other regulatory agencies, there has been a clear emphasis on continued compliance with predicate rules such as GLP. For example, since the GLPs have provided clear requirements regarding electronic audit trails from the beginning, compliance with GxPs has remained a major regulatory challenge for most firms striving to comply with existing and evolving regulations.
GCPs
As defined by the International Conference on Harmonization (ICH) (www.ich.org), "GCP 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. However, GCP regulations and guidances are generally less explicit regarding electronic record systems and data than those regulations and guidances in the laboratory and manufacturing arenas. The broad nature of GCP regulations and guidelines often leads to confusion about how best to ensure quality and compliance of systems in the clinical environment.
Regulatory bodies are working closely with industry to develop electronic data and submission standards, including but not limited to work with the Clinical Data Interchange Standards Consortium (CDISC), the Medical Dictionary for Regulatory Affairs (MedDRA) Maintenance and Support Services Organization (MSSO), and Secure Access for Everyone (SAFE), as well as with ICH regarding quality, efficacy, safety, and multi-disciplinary guidelines.
The shift of medical records from paper to electronic formats has increased the potential for individuals to access, use, and disclose personal health data, with information technology improving the effectiveness and efficiency of collecting, compiling, analyzing, and delivering personal information on a global basis. These changes in operational efficiency and effectiveness, however, raise new challenges and opportunities for ensuring appropriate privacy and security protections within the clinical research environment.
cGMPs
cGMPs demand that manufacturers, packagers and distributors of drugs, medical devices, food, and blood take proactive steps to ensure that their products are safe and effective. The language used in the regulations is both broad and subjective, which allows (and moreover 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. These innovations will undoubtedly require state-of-the-art technologies that are implemented and maintained by highly qualified people.
How Patni Can Help
Patni provides skilled resources to assist companies in understanding and interpreting key regulatory concepts in order to make informed decisions in areas such as electronic record keeping, personnel qualifications and training, validation, and complaint handling. Through the use of risk management principles, Patni provides companies with valuable strategies that can be used in all areas of GxP compliance. Patni has extensive experience and knowledge of industry best practices used in the implementation and validation of the systems often associated with the manufacturing, tracking and distribution of regulated products.
By taking a business-driven, risk-based approach to the implementation and validation of computer systems used in the drug development life cycle, Patni 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.
Auditing and assessment activities range from selecting, implementing, and validating audit tracking systems for use by an internal Quality Assurance group to assessing the regulatory compliance of contract research and contract manufacturing organizations. Patni works with you as an independent resource or as a member of your team, ensuring knowledge-sharing is a component of the end product.
Patni assists and guides you through the maze of US, non-US, and international privacy and security regulations and guidelines to help define and implement a governance model that helps protect your clinical trial subjects and product consumers.
Regardless of the size of the project, Patni's experts will guide you through the regulatory issues and ensure your systems or programs are implemented using proven, practical, risk-based approaches.
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