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Leucine Team
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36 mins

Contents

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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.

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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.

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

Unordered list

  • Item A
  • Item B
  • Item C

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Bold text

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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.

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What is a Batch Manufacturing Record?

The Batch Manufacturing Record (BMR) is an essential document capturing critical details of pharmaceutical production processes. From dispensing raw materials to the final stages of packaging, the BMR is integral for maintaining the integrity and quality of pharmaceutical products. This document serves as an exhaustive audit trail for regulatory bodies like the FDA, ensuring each product batch complies with the intended specifications and current Good Manufacturing Practices (cGMP). In the pharmaceutical industry, where patient safety is paramount, the BMR underscores manufacturers' commitment to health and safety standards.

With the evolution of Pharma 4.0, industry leaders are increasingly adopting AI-powered electronic Batch Records (eBMRs). These advancements are revolutionizing manufacturing by improving data integrity, enhancing production visibility, and streamlining processes, marking a significant leap forward in pharmaceutical manufacturing technologies.

Essential Components of a Batch Manufacturing Record

A comprehensive BMR should include the following key components:

  • Batch Identification: Details such as batch number, product name, and manufacturing date.
  • Raw Material Information: Specifications, quantities, and supplier details of all raw materials used.
  • Manufacturing Instructions: Step-by-step procedures and parameters for each stage of production.
  • Equipment and Facility Details: Information on equipment used, including calibration and maintenance records.
  • Quality Control Tests: Specifications, results, and approval status of in-process and final product testing.
  • Documentation of Deviations: Record and rationale of any deviations from standard procedures and their resolutions.
  • Signatures and Approvals: Signatures of all personnel involved in the manufacturing and quality control process.

Incorporating these components ensures the BMR provides a transparent, detailed, and compliant record of the manufacturing process.

What are the Most Important Regulatory and Audit Requirements for a BMR?

  • Compliance with Good Manufacturing Practices (GMP): BMRs must comply with established GMP guidelines and regulations, such as those outlined by regulatory authorities like the FDA, EMA, TGA, Health Canada, and others. This includes documenting all aspects of the manufacturing process to ensure product quality, safety, and consistency.
  • Accuracy and Completeness: BMRs must be accurate and complete, providing a detailed record of all activities and procedures conducted during the manufacturing process. This includes information on raw materials, equipment used, processing steps, in-process controls, testing, and any deviations or corrective actions taken.
  • Data Integrity and Traceability: BMRs should ensure data integrity, meaning that the information recorded is accurate, reliable, and attributable. There should be mechanisms in place to prevent unauthorized alterations or deletions of data. Additionally, BMRs should facilitate traceability, allowing for the tracking of materials and processes from raw materials through to finished product release.
  • Review and Approval: BMRs must undergo thorough review and approval by authorized personnel, including quality assurance and quality control personnel, before product release. This ensures that the manufacturing process was conducted in accordance with approved procedures and regulatory requirements.
  • Retention and Accessibility: BMRs must be retained for a specified period as per regulatory requirements, typically several years. They should be stored in a secure and accessible manner to facilitate regulatory inspections and audits. Additionally, there should be provisions for the retrieval of BMRs in the event of recalls, investigations, or regulatory inquiries.

Meeting these regulatory and audit requirements ensures that BMRs serve as comprehensive and reliable documentation of the manufacturing process, supporting product quality, regulatory compliance, and patient safety in the pharmaceutical industry. For a comprehensive overview of the relevant guidelines, click here.

What are Some Other Challenges that Pharmaceutical Manufacturers Face Relating to BMRs?

Pharmaceutical manufacturers face several challenges related to their Batch Manufacturing Records (BMRs). Some of these include:

  • Complexity and Volume of Data: BMRs often contain a vast amount of detailed information, including raw material specifications, processing parameters, in-process testing results, and documentation of deviations or corrective actions. Managing, interfacing and organizing this data can be complex, particularly for large-scale manufacturing operations with multiple product lines and production sites.
  • Version Control and Documentation Updates: Keeping BMRs up-to-date with the latest revisions, amendments, and regulatory changes poses a challenge for manufacturers. Ensuring version control and tracking changes accurately across multiple copies of BMRs can be challenging, especially in dynamic manufacturing environments with frequent process modifications and updates.
  • Integration with Manufacturing Systems: Integrating BMRs with manufacturing execution systems (MES) and other electronic systems is essential for real-time data capture, process monitoring, and automated documentation. However, achieving seamless integration across different IT platforms and ensuring data interoperability can be technically challenging and require significant investment in IT infrastructure and resources.
  • Training and Competency: Training personnel involved in the preparation, review, and approval of BMRs is crucial for maintaining data accuracy, consistency, and compliance. Ensuring that personnel are adequately trained and competent in documentation practices, GMP requirements, and regulatory standards is an ongoing challenge for pharmaceutical manufacturers.
  • Audits and Inspections: BMRs are subject to regulatory audits and inspections by health authorities to assess compliance with GMP requirements and product quality standards. Ensuring that BMRs are audit-ready, readily accessible, and meet regulatory expectations poses a challenge for manufacturers, requiring meticulous preparation and documentation management.

Addressing these challenges requires a holistic approach that encompasses process optimization, technology adoption, training and competency development, and continuous improvement initiatives to enhance the effectiveness, efficiency, and compliance of BMR-related processes in pharmaceutical manufacturing.

Top Tips for BMR Management

Conduct regular training sessions on GMP and documentation practices.

  • Utilize digital solutions for data management and process integration.
  • Implement and maintain strict version control procedures.
  • Regularly review and update BMR documentation and practices.

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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