Heading

Leucine Team
This is some text inside of a div block.
36 mins

Contents

Heading

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Heading 1

Heading 2

Heading 3

Heading 4

Heading 5
Heading 6

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur.

Block quote

Ordered list

  1. Item 1
  2. Item 2
  3. Item 3

Unordered list

  • Item A
  • Item B
  • Item C

Text link

Bold text

Emphasis

Superscript

Subscript

Heading

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Heading

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Heading

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Heading

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Heading

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

You may like

Learn the new digital way of managing cleaning validation using software

Book a demo with us now
Book a Demo

Top FDA Observations relating to Batch Execution in 2023

From the 510 warning letters issued by the FDA in 2023, The FDA issued a total of 17 Form 483s relating to Batch Execution in 2023 (and 629 relevant observations). This article serves as a curated snapshot of the Batch Execution related FDA observations made in 2023, offering a concise yet insightful overview of the trends, challenges, and opportunities faced by pharmaceutical companies. Whether you're a seasoned professional seeking to stay informed about the latest industry developments or a newcomer navigating the intricacies of FDA compliance, this guide is designed to provide you with valuable insights at a glance.

Procedures Not in Writing or Fully Followed (Quality Control Unit)

Cite ID: 1105; 1361; 1215; 4402
Frequency:
309 observations

Impacted Departments:

  • Quality Control
  • Production

Impacted Processes:

  • Quality System Management
  • Document Control
  • Training and Competency Assurance

Recommendations:

  1. Establish Robust Written Procedures: Ensure comprehensive documentation of all operational and quality control procedures.
  2. Regular Training Programs: Implement ongoing training for staff to reinforce the importance of adherence to established procedures.
  3. Quality System Audits: Conduct periodic audits to identify non-compliance and implement corrective actions promptly.

Scientifically Sound Laboratory Controls

Cite ID: 3603
Frequency: 84 observations

Impacted Departments:

  • Quality Control Laboratory
  • Research and Development

Impacted Processes:

  • Laboratory Testing Procedures
  • Control of Laboratory Equipment
  • Data Integrity and Documentation

Recommendations:

Strengthen Laboratory Controls: Enhance the scientific rigor of laboratory testing procedures and controls.

Equipment Calibration and Maintenance: Ensure all laboratory equipment is regularly calibrated and maintained.

Documentation and Data Integrity: Prioritize thorough documentation and uphold the highest standards of data integrity.

Inappropriate equipment design, size or location

Cite ID: 1177
Frequency: 74 observations

Impacted Departments

  • Quality Assurance (QA): They are primarily responsible for maintaining the quality of the production process and ensuring compliance with regulatory standards.
  • Engineering and Maintenance: This department is responsible for the design, installation, and upkeep of equipment.
  • Production/Manufacturing: The core department where the equipment is used, impacting the manufacturing process directly.
  • Facility Management: They oversee the physical layout and environment of the manufacturing space.
  • Safety and Compliance: This department ensures that all equipment and processes meet safety regulations and compliance standards.

Impacted Processes

  • Product Manufacturing: Inappropriate equipment can lead to defects, contamination, or inefficiencies in the manufacturing process.
  • Quality Control: Incorrect equipment design can affect the accuracy and reliability of quality control tests.
  • Cleaning and Maintenance: Inadequate equipment can be harder to clean and maintain, increasing the risk of contamination or downtime.
  • Material Handling and Storage: If equipment is poorly located, it can affect the flow of materials and efficiency of storage.
  • Documentation and Record-Keeping: Inadequate equipment can lead to improper data collection or recording processes.

Recommendations

  1. Regular Equipment Review: Conduct regular reviews and validations of all equipment to ensure they meet design specifications and regulatory requirements.
  2. Design and Layout Planning: Involve cross-functional teams in planning the design and layout of equipment to ensure it meets operational and compliance needs.
  3. Preventive Maintenance: Implement a robust preventive maintenance program to ensure equipment remains in good working condition.
  4. Training: Provide regular training for employees on the correct use, cleaning, and maintenance of equipment.
  5. Change Management: Implement a formal change management process for any changes to equipment or processes to ensure they meet regulatory standards.
  6. Documentation: Maintain thorough documentation for all equipment, including design specifications, maintenance records, and validation reports.
  7. Mock Audits: Conduct regular mock audits to identify potential issues and address them before an actual regulatory audit.

Observations relating to computer control of master formula records

Cite ID: 1263
Frequency: 61 observations

Impacted Departments

  • Quality Assurance (QA): Responsible for ensuring the integrity, accuracy, and security of master formula records.
  • Information Technology (IT): Oversees the infrastructure, security, and access controls for computer systems managing these records.
  • Production/Manufacturing: Uses these records for the correct formulation and production of products.
  • Quality Control (QC): Relies on accurate master formula records for validating production processes and product specifications.
  • Regulatory Affairs: Ensures compliance with all regulatory requirements related to electronic records and electronic signatures.

Impacted Processes

  • Recipe/Formulation Management: The process of creating, reviewing, and updating the master formula records.
  • Batch Production: Use of master formula records to manufacture products.
  • Document Control and Record-keeping: Managing access to, and revisions of, electronic records.
  • Audit and Compliance: Internal and external audits that assess compliance with regulatory requirements.
  • Data Integrity and Security: Ensuring that electronic records are accurate, unchanged, and accessible only to authorized personnel.

Recommendations

  1. Validation of Systems: Regularly validate computer systems used for managing master formula records to ensure they are functioning correctly and securely.
  2. Access Control: Implement strict access controls and user permissions to ensure that only authorized personnel can access, edit, or approve master formula records.
  3. Data Backup and Recovery: Ensure that there are reliable backup and recovery procedures for electronic records to prevent data loss.
  4. Audit Trails: Maintain comprehensive and tamper-evident audit trails for all actions related to master formula records, including creation, modification, and deletion of records.
  5. Regular Training: Provide ongoing training for relevant personnel on the proper use of the computer systems and the importance of maintaining the integrity of electronic records.
  6. Periodic Reviews: Conduct periodic reviews of master formula records and the systems that control them to ensure they remain accurate and compliant.
  7. Change Management: Implement a formal change management process for any changes to computer systems or master formula records to ensure continued compliance and integrity.
  8. Document Policies and Procedures: Develop and maintain clear policies and procedures regarding the creation, modification, and maintenance of master formula records.

Lack of control procedures to monitor and validate performance

Cite ID: 3585
Frequency: 48 observations

Impacted Departments

  • Quality Assurance (QA): This department is primarily responsible for establishing, implementing, and maintaining control procedures.
  • Quality Control (QC): Involved in monitoring, testing, and validating product quality and performance.
  • Production/Manufacturing: Directly impacted by control procedures as they relate to the performance and quality of manufacturing processes.
  • Engineering and Maintenance: Ensures that equipment and machinery perform within required specifications.
  • Research and Development (R&D): May be affected if product performance does not meet intended design due to lack of control procedures.

Impacted Processes

  • Process Monitoring and Control: Continuous monitoring and control of manufacturing processes to ensure they are within designated parameters.
  • Validation and Verification: Procedures for validating and verifying equipment, processes, and product performance.
  • Product Testing: Regular testing of products to ensure they meet quality and performance standards.
  • Change Control: Management of changes in processes, equipment, or materials that could affect product quality.
  • Documentation and Record-keeping: Maintaining accurate records of performance monitoring, validation activities, and control procedures.

Recommendations

  1. Develop and Implement Control Procedures: Establish clear, written procedures for monitoring and validating performance at all stages of product development and manufacturing.
  2. Regular Training: Train employees on the importance of following control procedures and on the specific steps they need to take as part of their job roles.
  3. Continuous Monitoring and Review: Implement continuous monitoring of processes and equipment to ensure consistent performance and compliance with specifications.
  4. Regular Validation and Calibration: Regularly validate and calibrate equipment and processes to ensure they are capable of producing quality products.
  5. Documentation: Maintain thorough documentation of all control procedures, monitoring results, and validation efforts to provide evidence of compliance.
  6. Internal Audits: Conduct regular internal audits to assess the effectiveness of control procedures and to identify areas for improvement.
  7. Corrective and Preventive Actions (CAPA): Establish a CAPA system to address any deficiencies identified during monitoring and validation activities.
  8. Management Review: Regularly review monitoring, validation, and performance data with management to ensure continuous quality improvement.

Calibration / inspection / checking not done

Cite ID: 1274

Frequency: 28 observations

Impacted Departments

  • Quality Assurance (QA): Ensures compliance with all calibration and inspection requirements and oversees the overall quality systems.
  • Maintenance/Engineering: Responsible for conducting and documenting the calibration, inspection, and checking of equipment.
  • Production/Manufacturing: Relies on properly calibrated and inspected equipment to produce safe and compliant products.
  • Quality Control (QC): Depends on calibrated equipment for accurate testing and validation of product quality.
  • Research and Development (R&D): In cases where new equipment or processes are being developed, proper calibration is essential for accurate research outcomes.

Impacted Processes

  • Equipment Calibration: Ensuring all equipment is operating within specified limits.
  • Routine Inspections: Regular checks to ensure equipment and processes are functioning correctly.
  • Quality Control Testing: Using calibrated instruments to conduct tests that validate product quality and safety.
  • Production Processes: Dependence on accurate, calibrated equipment for consistent manufacturing processes.
  • Document Management: Recording and tracking of calibration and inspection activities.

Recommendations

  • Regular Calibration Schedule: Implement and adhere to a strict calibration schedule for all relevant equipment, documented clearly.
  • Training Programs: Ensure all personnel involved in calibration, inspection, and checking are adequately trained and understand the importance of these activities.
  • Record-Keeping: Maintain meticulous records of all calibration, inspection, and checking activities, including dates, results, and individuals performing the tasks.
  • Routine Internal Audits: Conduct regular internal audits to verify that calibration and inspection processes are followed correctly.
  • Corrective and Preventive Actions (CAPA): Implement a CAPA system to address any issues identified during calibrations or inspections promptly.
  • Equipment Labels: Use clear labeling on equipment to indicate its calibration status and the date of the next scheduled calibration.
  • Validation of Procedures: Regularly review and validate calibration and inspection procedures to ensure they are effective and comply with current standards.
  • Cross-Departmental Communication: Ensure clear communication between departments regarding the calibration and inspection schedules and outcomes.

Lack of training (in operations, GMPs, written procedures)

Cite ID: 1112

Frequency: 25 observations

Impacted Departments

  • Quality Assurance (QA): Primarily responsible for ensuring staff are trained in quality control and regulatory compliance.
  • Human Resources (HR): Involved in organizing training sessions, maintaining training records, and ensuring all staff complete necessary training.
  • Production/Manufacturing: Directly affected as the staff needs to understand operational procedures and GMPs to maintain product quality.
  • Quality Control (QC): Needs trained personnel to accurately perform tests and ensure product safety and efficacy.
  • Regulatory Affairs: Ensures company compliance with all regulatory guidelines, including training requirements.

Impacted Processes

  • Product Manufacturing: Inadequate training can lead to errors in product production, affecting quality and safety.
  • Quality Control and Testing: Incorrect testing procedures can result from poor training, leading to unreliable product quality results.
  • Document Control: Ineffective training can result in improper documentation practices, critical for regulatory compliance and quality assurance.
  • Incident Handling and CAPA: Without adequate training, employees might not effectively handle incidents or implement corrective and preventive actions properly.

Recommendations

  1. Comprehensive Training Programs: Develop and implement comprehensive training programs covering operations, GMPs, and all relevant procedures. Ensure they are updated regularly to reflect current standards and practices.
  2. Regular Training Sessions: Conduct regular, scheduled training sessions and ensure all new employees undergo orientation before starting work.
  3. Training Records: Maintain meticulous records of all training sessions, including attendance logs and assessments of understanding.
  4. Assessment and Re-training: Regularly assess employee knowledge and competence, providing re-training where necessary.
  5. Role-Specific Training: Ensure that training programs are tailored to the specific roles and responsibilities of each employee.
  6. Training on Updates: When procedures or regulations change, provide immediate training to all relevant staff.
  7. Engagement and Feedback: Engage employees in the training process and encourage feedback to improve training effectiveness.

Mock Inspections: Conduct regular mock inspections or audits to reinforce training and prepare staff for real regulatory inspections.

Connect with a Leucine expert and become a facility of future

Book a demo with us now
Schedule demo

Heading 1

Heading 2

Heading 3

Heading 4

Heading 5
Heading 6

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur.

Block quote

Ordered list

  1. Item 1
  2. Item 2
  3. Item 3

Unordered list

  • Item A
  • Item B
  • Item C

Text link

Bold text

Emphasis

Superscript

Subscript