Quality Assurance

GMP Quality Capabilities

Fundamental Elements of LTI's Quality Management System

Recognizing the importance of product development, preparation of clinical study finished product, and supportive technical services, assured quality is an integral facet of bringing a new product to the clinic, contributing to improved patient outcomes. Quality is an essential aspect of the activities and scientific endeavors to be coupled with proper discipline in the methods of preparing products suitable for their intended use for treatment of patients in need. This spans all facets of product design, development, process engineering, as well as preparation of investigational materials for clinical studies.

For simplicity and clarity of focus, and an emphasis on quality of product and services as an integral part of our culture, there is a commitment to implement sound scientific principles and applicable GMP standards for all development activities and manufacturing processes. This commitment is inherent in the Quality Management System (QMS) to assure suitable quality in all activities at LTI. Consistency of results is achieved by applying appropriate principles, scientific discipline, with flexibility in addressing unique challenges, realizing flexibility is essential: Any single approach does not address every challenge.

Suitable quality and compliance are attained through a culture created by applying principles of good science coupled with a focus on quality. This culture is fostered by taking required steps for assuring sound scientific principles, quality and compliance are incorporated in all aspects when completing activities.

This rigorous quality and science-based culture is reflected in achieving a high level of control through operation and management systems:

• Routine training programs on the science, technology, quality and compliance aspects in developing and preparing lyophilized products
• Supplier qualification
• Identification, control and tracking of product components and materials
• Routine equipment and instrument calibration and maintenance
• Thorough equipment qualification and rigorous process validation
• Process robustness for inter-batch process reproducibility and product consistency
• Contamination control and cleaning verification strategy
• Method and process validation appropriate for product lifecycle
      (FDA Stage 1, 2 and 3*, ICH QB, Q9, QlO and Q12**)
• Measures to achieve bioburden control for bulk intermediates intended for clinical studies
• Control measures in place to assure a high level of confidence in achieving chemical and microbiological purity of investigational materials for use in clinical studies
• Records and documents suitable for reference in regulatory submission for product approval
• Independent data verification, technical review and quality assessment for:
  • Calibration and maintenance
  • Facility and operations safety
  • Formal development batch records and minimal use of lab notebooks Detailed clinical manufacturing batch records Development and manufacturing documentation
• Management oversight of change control and variances
• Comprehensive change control meeting quality and compliance requirements
• Proper risk assessment coupled with knowledge management as an integral Quality System
• Management engagement in performance analysis and Quality Management System

*FDA Guidance for Industry, Process Validation: Principles and Practices, US Food and Drug Administration, January 2011. ** International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

This approach to quality compliance makes the transition from drug discovery to commercial product launches a clear and achievable pathway. Applying appropriate GMP quality principles, starting with development activities and continuing through preparation of investigational materials in clinical supply manufacturing, assures confidence in dependable documentation. Such assurance in detailed documentation and data integrity results in efficient and effective data assembly to support regulatory submission for product approval. In addition to the quality team, all staff understand and implement quality standards to meet compliance requirements of all applicable regulations and guidelines. This includes US and global governing authorities. It is recognized and inherent in all development activities that product quality results from using verified materials, effectively executing proper procedures, and culminates with proper product preparation, not in an assessment during final review or by finished product testing. Such assessments and testing are viewed as simply a verification of what is appropriate and completed correctly.

GPM quality also applies to communication. This encompasses direct, transparent, and timely communication between the study sponsor and the scientist leading the project. It is also reflected in complete and detailed batch documentation for development projects and preparation of investigational material for clinical studies. Such documentation is supplemented by comprehensive reports summarizing the data and interpreting observations and results.

There is pride in taking a supporting role in developing new products and preparation of investigational materials for first-in-human administration as well as expanded and extended clinical studies. The challenges in developing new health care products can be diverse and range from simple to complex. Disciplined and flexible approaches, leveraging on extensive knowledge, experience and expertise yields sustainable solutions and successful outcomes. The unending attention to quality, consistency, capacity, and reliability in providing products and services is essential to innovators in the pursuit of bringing new health care products. Unquestionable quality, when providing critical health care products to patients with the ambition of meeting their unique health care needs and improving therapeutic outcomes, is paramount for a QMS program.