Quality Assurance

Our regulatory and quality assurance team members have developed and implemented quality systems in accordance with the following:

• Current Good Manufacturing Practices (21 CFR 210 and 211, 600, 601, 610 and 820)
• Combination Products GMPS (21 CFR 4)
• Pharmaceutical Development (ICH Q8)
• Risk Management (ICH Q9)
• Quality Systems (ICH Q10),
• Good Manufacturing Practices for Active Pharmaceutical Ingredients (ICH Q7A)
• EU Good Manufacturing Practices (Eudralex Volume 4)
• Australia’s PIC/S Guide to Good Manufacturing Practices

We assist you with organizational activities, plans, policies, procedures, processes, and provide the resources associated with designing, implementing, and maintaining a quality system focused toward meeting customer satisfaction. BioTechLogic Inc. supports our clients’ Quality Assurance departments by providing the following services:

Quality Systems Procedures

BioTechLogic designs and implements quality system procedures and instructions in accordance with corresponding regulatory requirements. Examples of quality system procedures and instructions include but are not limited to:

• Design and implement quality systems
• Standard operating procedures (SOP) and forms
• Detailed specification development
• Regulatory documentation preparation
• Quality manuals
• Quality policy and objectives

Quality Systems Analysis and Improvements

BioTechLogic provides advice for the continuous improvement and analysis of your quality system. Examples of quality system analysis and improvement services include but are not limited to:

• Quality system analysis and improvements
• Quality system upgrades to new standards and requirements
• Corrective and preventive actions (CAPA)
• Failures, deviations, and out of specification (OOS) investigations
• Mitigation strategies and plans were deficiencies have been identified
• Quality plans
• Quality risk management
• Quality mapping
• GMP training
• Resource Management

BioTechLogic provides additional resources to your quality assurance department to help achieve goals and deadlines by:

• Document review and identifying actions required to meet regulatory requirements and ensure product quality
• On-site support ensuring operational compliance and additional assistance during regulatory inspections
• Quality Assurance and Post Market Compliance Audits

Quality Assurance Audits

“We (FDA) are intentionally going to direct investigators to do more inspections near term to your approval for certain kinds of products. So, we have added inspection resources in a program that we have had around for many year, but let lapse for about 10 years, but we have reinstituted this fiscal year and will continue for the next several years at least. This is what we call our post-marketing compliance program. It is designed to get investigators into facilities to look at processes and products that received approval within the last year or so.”

They will primarily look at three things:

1) Process Validation: How you execute it. What do the short-term commercial production experiences tell you about the adequacy of that process and product?
2) Stability: Real time, controlled room temperature or whatever its storage condition is; and,
3) How you control components: “Because that is another key variable, and increasingly of greater interest to us.”

–CDER official Brian Hasselbalch as reported by Bill Paulson. International Pharmaceutical Quality. July/August 2009. Vol. 3, No. 4, pg. 11

BioTechLogic is an industry expert in Process Validation. Our experienced process and quality personnel will review your Process Validation Life Cycle program and executed studies to determine your readiness for an inspection. Examples of our continuous process monitoring audit services include:

• Review Process Validation Life Cycle Procedures to ensure that they reflect the life cycle approach: Design, Confirm, Monitor, Assess and Change Control (Maintenance and Optimization)
• Evaluate Design and Development Studies executed to define the manufacturing process
• Evaluate Process FMEAs that established potential critical unit operations, process parameters, raw materials, components, equipment and facilities
• Evaluate Lab Pre-Qualification and DOE studies that evaluated potential critical unit operations, parameters and ranges, raw materials, components, equipment and facilities
• Review executed Process Qualification Report including strategy for increased sampling and statistical rigor
• Review Life Cycle Trending Procedures or Continuous Monitoring Protocols for process maintenance and improvement