Services

Quality & Compliance Systems

An overwhelming number of companies do not recognize the criticality of creating and approving a development report and updating it regularly throughout the manufacturing phases. Without a well documented development history, manufacturing changes may be unsupported during review or inspection, leading to rejection.

Therefore, a company’s success is contingent on having robust quality and compliance systems to integrate disciplines across the company vital to the evaluation of changes in the development program and ensure that consequential missteps are avoided. Compliance Strategies, Inc. is well versed in establishing these quality and compliance systems that identify critical milestones throughout development.

Compliance Strategies, Inc. can help you streamline the implementation of policies and quality management systems for validation, document management, change control, manufacturing deviations, quality review, and CAPA (corrective and preventive action), to name a few.

Process Definition, Mapping & Streamlining

Ever since the concept of process validation was first introduced in the 1970s, it has undergone continual improvement but in the last few years, it has undergone a paradigm shift. Instead of validating a certain set of process parameters without the full understanding of whether it was close to an edge of failure, the Quality by Design (QbD) initiative, principle component analysis (PCA), and neural nets have converged to revolutionize the assessment of what is a critical process parameter and how best to control its impact on product quality or structure activity relationships.

This evolutionary thought process is evident in the Center for Device & Radiological Health (CDRH) requirements for HACCP (Hazard Analysis & Critical Control Point) for medical devices, the Center for Biologics Evaluation & Review (CBER) guidance on biologics process development & validation, as well as the Center for Drug Evaluation & Review (CDER) guidance on cGMPs in the 21st Century.

Compliance Strategies, Inc. has extensive experience in the review and evaluation of process controls and specifications germane to product quality.

Development of Global Systems

Developing a global quality system is absolutely essential for any firm with a multi-national business interests. They must understand the regulatory and cultural aspects for each market and integrate those quality concepts into their global development and registration strategy. As more firms engage resources across the globe, such as contract manufacturing or licensing partners, it is key to establish a harmonized framework to outline the steps necessary for the success of the project.

System Audits, GXP Audits (cGMP, GLP, & GCP) & FDA Readiness

System audits follow the FDA inspection program of Quality System Inspection Technique (QSIT), which is a process to review compliance against the quality systems regulations and related regulations. GXP audits include GMP, GLP, and GCP areas.

Compliance Strategies, Inc. has experience in both system audits, for cause audits for areas covering all regulations, and project-related audits.

It is essential for companies to understand and implement all regulatory requirements. In order to ensure successful regulatory inspections, companies must have a plan on how they prepare. This preparation should include personnel, documents, and management. Employing an outside resource to review systems and procedures more closely mimics a regulatory agency inspection. Mock pre-approval inspections (PAI) have tremendous value in that it focuses the project management team on aspects that might be overlooked by an internal audit alone. As more firms engage resources across the globe, such as contract manufacturing or licensing partners, it is key to establish a harmonized framework to outline the steps necessary for the success of the project.

Due Diligence, Assessment & Vendor Qualification Program

To reduce investment risk, due diligence assessments are essential for companies expanding their partnerships in the industry. Such assessments can provided essential information such as history and standing of a company in the industry, capabilities of the site, and degree of associate risk. The qualification requirement is an initial examination or a reexamination of existing vendors.

Compliance Strategies, Inc. can establish a program that can reduce the costs associated with vendor qualification.

Documentation, Data & Batch Review

Quality review of executed documents and compiled data is a regulatory requirement and industry standard. At times, an evaluation and second opinion may be needed. Inconsistent results, trends, staffing limitations, or deadlines can be costly if not addressed.

Compliance Strategies, Inc. can provide all these services to assist management in achieving their goals.