Working Culture in USFDA Approved Pharmaceutical Plants

A USFDA approved pharmaceutical plant is not simply a manufacturing location that has passed an inspection; it is a facility that has quality, compliance and safety built into its daily operations as an organization (as opposed to a facility that uses validated systems, equipment and high tech equipment) to provide best in class products with minimal defects.

The difference between a highly compliant pharmaceutical facility and one that struggles from not complying with GMP requirements during inspections is evident in the employee's attitude toward Quality and Compliance. In successful USFDA approved plants, GMP does not represent an additional burden to the organization but instead represents an integral part of the day to day decision making at all levels of the organization.

Employees understand that everything they do may affect the safety and efficacy of the medications used by patients around the world. This mindset creates a culture where there is no fear of compliance due to an inspection but instead a commitment to providing high quality products.

What Defines a Strong Quality Culture?

Pharmaceutical manufacturers often refer to "quality culture," but rarely stop to consider what the term really means.
A strong culture for quality exists when an organization's employees are continuously making decisions that support the protection of product quality and patient safety, even under pressure of producing product or operational obstacles. The key elements of a strong culture for quality include:

• Responsibility and Accountability
• Procedural discipline
• Openness in communication
• Awareness of data integrity
• The desire to consistently improve
• Management commitment to quality

Quality Culture in an organization's USFDA approved facility does not only reside in the Quality Assurance Department. Other departments, such as production, engineers, warehousing, laboratory operations and Senior Management all have a role in assuring compliance with regulations and guidelines relating to quality.

Compliance Comes Before Production

One of the primary lessons learned while working in a highly compliant environment is that production schedules do not trump GMP violations.

Many production facilities in the pharmaceutical industry experience pressure to run faster, produce more and have shorter turn-around times on batch releases. In these same facilities, employees are trained to prioritize the quality of the product vs. the need to produce product. Some examples:

• Production will stop when there is a critical deviation
• Equipment will not be put into use unless there is an uncertainty as to the equipment's calibration status
• Batch release will only occur after a complete batch review
• Investigations must be completed prior to making a disposition decision

While using this approach may cause delays in production from time to time, it ensures compliance with regulatory requirements and the quality of the product.

Documentation Culture

In the U.S. FDA approved facility documentation practices serve to denote the working culture, as Employees are required to document their work in an accurate, legible and contemporaneous manner. Some common expectations are:

• Immediate recording of the information after a task is complete
• Avoiding the use of retrospective entries
• Following approved procedures for correcting documentation
• Keeping all documentation complete
• Being able to trace all activities that occurred

From my experience, facilities with strong documentation cultures often do not have data integrity issues because the Employees are familiar with the importance of maintaining good records.

Basic philosophy generally used by a facility with a good documentation culture:
"If you didn't write it, it didn't happen."

Data Integrity as a Daily Responsibility

The current trend for inspections performed by the FDA has an increasing focus on the data integrity that is created at manufacturing plants.

Anyone working at a manufacturing site that is approved by USFDA must have an understanding of the ALCOA principles that are applied to all data that they create.

• Attributable
• Legible
• Contemporaneously
• Original
• Accurate

In addition to the above principles, many organizations are now also stressing the following principles;

• Complete
• Consistent
• Enduring
• Available

Data integrity should not only be applied to laboratory operations but should also be a part of all records of manufacture, maintenance documentation, validation activities, environmental monitoring records, as well as computerized systems.

All employees should be trained in identifying and reporting any actions that could jeopardize the integrity of the data created during any of the activities previously mentioned.

Training Never Stops

Successful pharmaceutical companies are characterized by an ongoing commitment to staff education and training. Examples of training programs typically provided include:

• GMP standards
• Data integrity
• SOP reviews
• Quality risk management
• Safety regulations
• Regulatory expectations

At leading facilities, training is not viewed as compliance with regulations; instead, it is seen as a mechanism for developing employees and creating operational excellence. Many USFDA approved facilities offer their employees the following types of training:

• Annual GMP updates
• Workshops for preparing for inspections
• Practice interviews
• Assessing technical skills
• Performing practical demonstrations

This atmosphere of continual development promotes confidence and helps ensure that employees are always ready for inspections.

Inspection Readiness Every Day

The difference between mature and immature facilities is how they manage inspections. Facilities with weak cultures of compliance only get serious about inspection preparations when an inspection occurs. Facilities that are FDA certified operate differently. Employees are always ready for inspections. When this culture is in place:

• Documentation will be up-to-date
• Logbooks will be maintained correctly
• Procedures will be followed consistently
• Records will be available when needed
• Investigations will be completed promptly

With this type of culture, there will be less tension associated with inspection time because there is a continuous level of regulatory compliance versus a temporary level of regulatory compliance.

Open Reporting of Problems

When there is a positive compliance culture, employees feel free to report issues without any concern of consequences. Employees are encouraged to report the following:

• Deviation from established procedures
• Equipment malfunction or failure
• Errors in documentation
• Abnormalities in process
• Discrepancies in data

In my experience, organizations with restrictive cultures about reporting create larger compliance issues by allowing problems to be unreported until they reach a point of severity.

Staff from the USFDA have been known to have a more favorable view of companies that demonstrate transparency than those companies that are reticent about reporting the issues they encounter.

Cross-Functional Teamwork

Collaboration among multiple departments is critical to pharmaceutical manufacturing. The critical functional departments involved are:

• Production
• Quality Assurance
• Quality Control
• Engineering
• Warehousing
• Validation
• Regulatory Affairs

In well-functioning facilities, departmental groups work collaboratively to fix problems versus pointing fingers at each other for who previously made the error. When an exception occurs, teams will concentrate on:

• Identifying the cause(s) of the deviation
• Assessing the effect of the product (or lack thereof) on the health of the patient
• Developing, implementation and documentation of the corrective action and preventive action (CAPA) plan
• Taking steps to avoid recurrence of the exception

Collaboration among functional departments substantially increases the effectiveness of the operation.

Role of Management in Compliance Culture

Management's actions play a significant role in establishing the culture of a manufacturing facility. Employees generally act on whatever they observe through their management's actions first. For example, most employees will generally follow management's behavior rather than management's verbal communication. Facilities that have strong compliance cultures have management that:

• Encourages quality decision-making
• Provides training opportunities
• Provides adequate staffing / resources
• Is transparent with employees
• Encourages continuous improvement

I have noticed that facilities that provide active managerial involvement, when compared against other production facilities, have a higher level of compliance with good manufacturing practices (GMP).

Responsibility and Accountability

Workers in plants that have been approved by USFDA , have a responsibility to be accountable for the work they perform. "Ownership" is defined as:

• Following all procedures accurately.
• Verifying work done is accurate.
• Reporting any issues on time.
• Accurately completing required documentation.
• Assisting with investigations.

When an employee is held accountable for their actions, it creates trust in the completion of the job accurately and consistently. Without establishing accountability, all the procedures created and written will become useless.

Continuous Improvement Mindset

Regulatory compliance is an ongoing process. Successful pharmaceutical companies continually look for ways to improve their:

• Procedures
• Systems
• Documentation
• Training programs
• Quality metrics

The implementation of continued improvement initiatives can include:

• Implementation of Corrective and Preventive Action (CAPA)
• Lean manufacturing projects
• Digital Transformation
• Activities aimed at Risk Reduction
• Optimization of processes

Facilities that continually improve are likely to have a greater ability to adapt to changing regulatory requirements.

Behavior During FDA Inspections

During inspections by the FDA, employee behavior is usually indicative of the overall company culture. Typically, an employee in a facility approved by the FDA has had training to help them:

1. Respond honestly to all questions
2. Maintain professionalism
3. Avoid making assumptions or guesses
4. Provide accurate and truthful information
5. Refer or elevate questions as necessary

In evaluating systems and record keeping during the inspection process, inspectors also evaluate how employees know and practice GMP principles.

Well-informed and confident employees present the company as more mature than companies with less knowledgeable staff.

Technology and Modern Working Culture

The company’s shift to digital transformation is a massive change within the workplace of the pharmaceutical industry. The use of new technologies implemented by USFDA approved facilities after digitization include;

• Electronic Batch Records
• Manufacturing Execution Systems
• Laboratory Information Management System
• Electronic Quality Management Systems

These new technologies implement:

• Traceability
• Efficiency
• Compliance oversight
• Data integrity

Despite attending to all the above points with the use of these new technologies, having a quality culture amongst employees is of utmost importance. Therefore, ensuring that all your employees are educated on how to do their jobs based on Good Manufacturing Principles and regulations is critical.

Common Challenges in Maintaining Culture

Every organization, even one that is compliant, has its share of obstacles when it comes to maintaining an organization's culture. Some recurring issues include:

• Pushing for production
• Staff turnover
• Rapid and continuous growth of an organization
• Merger and/or acquisition activities
• Insufficient resources

An organization's culture of compliance requires ongoing attention and engagement from leadership as well as from employees.

Organizations that do not address cultural issues will have experiences with continuous occurrences of excursions, documentation errors and inspection findings.

Characteristics of Employees in Successful FDA Compliant Facilities

Employees with success in working at U.S. FDA approved facilities often display these attributes:

• Detail-orientation
• Strong adherence to procedures
• A focus on quality
• A desire to learn continuously
• Integrity/Honesty
• Accountability
• Teamwork

Each of these characteristics contributes to long-term compliance success.

Best Practices for Building a Strong Working Culture

The guidelines below outline practices to develop a strong compliance culture. The organization's compliance culture can be improved by assessing the following best practices:

• Ownership of quality at all levels
• Transparency in reporting
• Ongoing training
• Routine mock inspections
• Recognition of compliance behaviors
• Management involvement
• Periodic measurement of quality culture

Developing a strong culture will take time and effort.

The culture of a USFDA approved pharmaceutical plant goes far beyond simply complying with written procedures and laws; it is a shared commitment from everyone in the organization (collectively) to provide high-quality products along with providing safe products for patients, reporting results of tests accurately and making sure that the systems used by the company (e.g., manufacturing facilities) operate efficiently.

In my experience, best USFDA approved facilities are those that embed quality in everything they do daily versus treating quality as something required by law. In the companies that promote accountability, openness & honesty, continuous improvement and readiness for inspection, the customers will be provided with high levels of service and products as a result of continuous improvement efforts; therefore, creating an environment of sustained compliance and supporting both regulatory compliance and business performance.

Regulatory References

1. FDA Data Integrity and Compliance with Drug cGMP - https://www.fda.gov/media/119267/download
2. ICH Q10 Pharmaceutical Quality System - https://database.ich.org/sites/default/files/Q10_Guideline.pdf
3. EU GMP Guidelines Volume 4 - https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
4. WHO Good Manufacturing Practices Guidelines - https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/gmp

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