Dreading the Next FDA inspection?

Examine These Six Factors in Your Pharmaceutical Facility’s Process Definition and Controls

by Charles Spillman, DPA Senior Consultant

Click here to read how one pharma facility’s assessment and FDA compliance efforts succeeded.

The Food and Drug Administration (FDA)’s close oversight of the pharmaceutical industry through Good Manufacturing Practices (GMP), audit requirements and rigorous approvals give us, the public a high measure of confidence that our medicines and vaccines are safe and effective.

If you’re responsible for pharma manufacturing operations – including performance and reliability of critical equipment – you’re balancing FDA compliance measures with your company’s need to compete in a market full of treatment options, therapeutic alternatives, and price-sensitivities.

When was the last time your facility did a deep dive into the six factors that will help you pass your next FDA inspection? As in most cases, an ounce of prevention at your facility – based in self-knowledge and organizational awareness – is worth many pounds of cure.

How the FDA oversees pharma manufacturers: A quick refresher

When the FDA finds that a pharma manufacturing facility is out of compliance with any part of the required standards for GMP, the agency steps in and takes action. This action may range from coaching to help the firm come into compliance, to closing and condemning the facility, with many degrees of corrective measures in between. As a first action, the FDA may issue a warning letter that describes the violation found during its audit and the steps needed to address the area of concern.

Setting (or adjusting) Your Facility’s Compliance Roadmap

Knowing the areas of concern and potential pitfalls with the FDA is the first step for success. Having clear, concise procedures, with practices grounded in sound engineering and reliability rigors, is crucial to avoid problems with regulatory agencies. Documenting and demonstrating adherence to these rigors is just as important. Because there are so many proprietary processes specific to individual pharma production facilities, the processes may be entirely different from one location to another, making the importance of good documentation and adherence to methods even more critical.

Know (and address) Your Weaknesses

Organizational assessments, both internal and external, are the next step on this path. Knowing where your facility is in relation to the guidelines is crucial to success. A tool that is gauged to impartially critique your organizational capability will give you a platform to examine your present position and the steps that may be needed for improvement and compliance with GMP regulations. Follow an assessment with a plan for action (and remediation, if needed), and you can position your firm for the future.

Where to Begin

Launching an effort to protect your facility from running afoul of the regulatory authorities (that ounce of prevention)? Start with an understanding of where you are. Use an assessment tool to measure key performance factors that affect regulatory compliance and organizational performance. Daniel Penn Associates has developed a comprehensive tool for these types of assessments.

Whatever assessment tool your company uses should not only give you a clear understanding of where your facility currently is, but should also form the basis for an action plan designed to improve your competitive position. It should begin with six crucial aspects of process definition and control:

• Asset Management
• Process Control
• Documentation Management
• Work Management
• Supply Chain Control
• Organizational Development

Asset Management is the process and disciplines that ensure your physical assets (production and other) are correctly installed, supported and documented in a correct equipment hierarchy, in a Computerized Maintenance Management System (CMMS) and on current and correct piping and instrumentation diagrams (P&ID’s). Asset management also covers the disciplines and systems that ensure that appropriate Preventive and Predictive activities are in place to preserve the capacity of those assets.

Process Control is the system of manufacturing instructions, recipes and safeguards that any pharma production facility will use in the production of products intended for the market and the medical community. The critical control attributes are consistency, accuracy, and purity for the product array.

Documentation Management has everything to do with the way the organization defines itself, its processes and the records that are kept demonstrating adherence to production standards and maintenance requirements. This will include version control, a controlled repository and on-going training for standard operating procedures and the regulatory environment.

Work Management is more than simply utilizing a work order system; it includes constant and deliberate examination of the sources and remedies for recurrent failures (bad actors), training on and the use of non-destructive technologies, record-keeping for the regulatory authorities, metrics that measure effectiveness and efficiency and integration with all stakeholders in the facility.

Supply Chain Control is more than locking the storeroom; it is the disciplines needed to ensure that the needed maintenance, repair, and operations stores are kept in an appropriate environment, at adequate levels to meet demand and that appropriate security measures are in place to protect the work in progress and finished products.

Organizational Development is everything that the facility needs to ensure that the staff and management of the firm remain on the leading edge of learning, process optimization and research and development, where appropriate.

Has it been some time since you conducted an assessment of your pharmaceutical facility’s process definitions, controls, and procedures related to your critical assets? Concerned about your ability to pass the next FDA inspection? Do you need to onboard new employees in SOPs to remain compliant? Utilizing our comprehensive assessment tool, DPA’s team can help you proactively address issues that put you at risk of FDA action. Call Daniel Penn Associates at 860.232.8577 or email us at info@danielpenn.com

DPA Senior Consultant Charles Spillman, CMRP, CPIM, CSCM, CPMM has thirty years’ experience in consulting and facilities management, with projects ranging from maintenance enhancement to integrated and activity-based costing systems to budgetary control systems to productivity/scheduling improvement programs. He has teaching credentials with the Departments of Navy, Army, and Energy, teaching reliability practices, change management and management for engineers.

He serves a number of sectors: military and industrial, pharmaceutical, refining and petrochemicals, pulp and paper, primary metals, mining, food service, engineering, automotive stamping and assembly, software development, clerical, distribution and custom fabrication.

Prior to entering consulting, Spillman taught Business Administration at the University of Kentucky and continues as a visiting lecturer when time permits.