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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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Bold text

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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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BMR Guidelines - A Comprehensive Overview

The Batch Manufacturing Record (BMR) is a key document in the pharmaceutical manufacturing industry that captures the most important details pertaining to the production of a specific batch of a product, right from dispensing raw materials to manufacturing finished goods to storing and packaging them. It acts as an end-to-end audit trail for regulators to ensure compliance with cGMP, showing production operations. As the FDA puts it, ‘if it isn’t written down, it didn’t happen’. In other words, this document is another mechanism by which the FDA can verify that the batch has been manufactured according to its intended specifications. 

Due to the high impact the life sciences industry has on patient wellbeing, this document is a critical component of an effective GMP Compliance program at any regulated drug manufacturing facility.

In this e-book, we dive into the different regulations relating to the BMR that you must keep in mind to ensure the health and safety of your consumers.

U.S. Food and Drug Administration (FDA):

Part 211.188 of the Code of Federal Regulations requires detailed batch production and control records to be maintained for each batch of drug product produced.

Apart from 211.188, the U.S. Food and Drug Administration (FDA) also publishes several guidance documents that provide additional guidance and interpretation on CGMP requirements. Some key documents related to batch manufacturing records and CGMP compliance include:

  • FDA Guidance for Industry - Pharmaceutical CGMPs: This guidance document provides a comprehensive overview of CGMP requirements for the manufacture of pharmaceutical products. It covers various aspects of manufacturing, including batch production and control records.
  • FDA Guidance for Industry - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production: This guidance outlines procedures for investigating and handling out-of-specification (OOS) test results during pharmaceutical production. It emphasizes the importance of documenting investigations and actions taken in batch manufacturing records.
  • FDA Guidance for Industry - Process Validation: General Principles and Practices: This guidance provides recommendations for the validation of manufacturing processes, including batch processes. It highlights the importance of documenting process validation activities and results in batch records.
  • FDA Guidance for Industry - Data Integrity and Compliance With CGMP: This guidance addresses data integrity issues in pharmaceutical manufacturing, including the maintenance of accurate and complete batch records. It provides recommendations for ensuring the integrity of data recorded in batch records.

Key takeaways from these FDA guidance documents regarding batch manufacturing records include:

  • Batch manufacturing records must be detailed and comprehensive, documenting all critical steps in the manufacturing process.
  • Records should include information on raw materials, equipment used, processing steps, in-process controls, and finished product testing.
  • Batch records must be reviewed and approved by authorized personnel before product release.
  • Any deviations or discrepancies observed during manufacturing must be documented, investigated, and resolved, with the results recorded in the batch records.
  • Batch records should be maintained in a manner that ensures data integrity, accuracy, and accessibility throughout the product life cycle.
  • Manufacturers should establish and maintain robust documentation practices to demonstrate compliance with CGMP requirements and facilitate regulatory inspections and audits.

These key takeaways underscore the importance of maintaining accurate, complete, and compliant batch manufacturing records to ensure product quality, safety, and regulatory compliance in the pharmaceutical industry.

Useful Links 

  • FDA Guidance for Industry - Pharmaceutical CGMPs
  • FDA Guidance for Industry - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
  • FDA Guidance for Industry - Process Validation: General Principles and Practices
  • FDA Guidance for Industry - Data Integrity and Compliance With CGMP

European Medicines Agency (EMA):

Annex 16 of the EudraLex Volume 4 - Good Manufacturing Practice (GMP) Guidelines specifies requirements for batch documentation, including batch manufacturing records, which must be maintained for each batch of medicinal product, including certification by a qualified person and batch release.

Apart from these, the EMA also publishes several guidance documents that provide additional guidance and interpretation on GMP requirements. Some key documents related to batch manufacturing records and CGMP compliance include:

  • EU Guidelines to Good Manufacturing Practice: This document provides detailed guidance on GMP requirements for medicinal products for human and veterinary use in the European Union (EU). It includes specific requirements and recommendations for batch manufacturing records, including the content and format of these records. 
  • Annex 16 to the EU Guidelines to Good Manufacturing Practice: This annex specifically addresses certification by a Qualified Person (QP) and batch release requirements. It outlines the responsibilities of the QP regarding batch certification and release, including the review of batch manufacturing records.
  • EMA Guideline on Process Validation for Finished Products - Information and Data to be Provided in Regulatory Submissions: This guideline provides recommendations for the validation of manufacturing processes for finished pharmaceutical products. It includes requirements for documenting process validation activities and results in batch manufacturing records.
  • EMA Reflection Paper on GMP and Marketing Authorisation Holders: This document discusses the responsibilities of marketing authorization holders (MAHs) regarding compliance with GMP requirements, including the maintenance of batch manufacturing records. It emphasizes the importance of accurate and complete documentation to ensure product quality and patient safety.

Key takeaways from these EMA guidance documents regarding batch manufacturing records include:

  • Batch manufacturing records should be comprehensive and include detailed information on all aspects of the manufacturing process, including formulation, processing steps, packaging, and testing.
  • Records should be maintained in accordance with GMP requirements and should be readily available for inspection by regulatory authorities.
  • The responsibilities of the QP include certifying the compliance of each batch with regulatory requirements based on a review of the batch manufacturing records.
  • Process validation activities should be documented in batch records, including the rationale for process parameters and acceptance criteria.
  • MAHs are responsible for ensuring that batch manufacturing records are accurate, complete, and maintained in compliance with GMP requirements throughout the product lifecycle.

Useful Links

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) Guidelines

Annex 16 to the EU Guidelines to Good Manufacturing Practice

EMA Guideline on Process Validation for Finished Products

EMA Reflection Paper on GMP and Marketing Authorisation Holders

World Health Organization (WHO):

WHO Good Manufacturing Practices for Pharmaceutical Products emphasizes the importance of batch production records, which should include all significant processing and packaging records. 

World Health Organization (WHO)

Annex 2 from the WHO Technical Report Series provides an extensive framework for good manufacturing practices for sterile pharmaceutical and biologics products, emphasizing the critical aspects of Batch Manufacturing Records (BMR) and compliance:

WHO Guidelines for Sterile Pharmaceutical Products: The document offers an exhaustive overview of GMP requirements for the manufacture of sterile pharmaceutical products. It delves into numerous manufacturing facets, including premises design, equipment setup, utilities, personnel, production processes, environmental and process monitoring, and quality control.

Documentation and Batch Records: Annex 2 outlines requirements for maintaining comprehensive batch records for each production batch. These records should meticulously document the manufacturing process, ensuring adherence to approved procedures. It underscores the necessity of batch records to verify that products are consistently produced and controlled according to quality standards.

Retention and Management of Records: It stipulates that manufacturing batch records must be preserved for a specified period, typically until one year after the product's expiration date, ensuring they are readily available for inspection by regulatory authorities.

Comprehensive Guidelines for Quality Control: The annex stresses the significance of thorough quality control measures in the manufacturing process, encompassing validation and quality control testing to confirm products meet quality standards.

Key takeaways from WHO Annex 2 regarding Batch Manufacturing Records include:

  • BMRs must be comprehensive and thorough, documenting all crucial steps in the sterile manufacturing process.
  • The records should detail information on raw materials, equipment utilized, manufacturing steps, in-process controls, and testing of finished products.
  • Batch records must undergo review and approval by authorized personnel prior to product distribution.
  • Any deviations or anomalies observed during manufacturing should be fully documented, investigated, and rectified, with outcomes recorded in the BMRs.
  • BMRs should be managed to ensure data integrity, accuracy, and availability throughout the product’s lifecycle.

These guidelines underscore the importance of maintaining detailed and compliant BMRs to assure product quality, safety, and adherence to regulatory requirements in sterile pharmaceutical manufacturing.

Useful Links:

WHO Good Manufacturing Practices for Pharmaceutical Products

Annex 2: WHO good manufacturing practices for sterile pharmaceutical products

Pharmaceutical Inspection Co-operation Scheme (PIC/S):

The PIC/S Guide to Good Manufacturing Practice for Medicinal Products emphasizes the importance of batch records in ensuring the quality, safety, and efficacy of medicinal products.

While PIC/S may not have standalone guidelines exclusively dedicated to batch manufacturing records, some key documents and takeaways related to batch manufacturing records within the framework of PIC/S:

  1. PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-13):
  • Batch manufacturing records should be detailed and comprehensive, documenting all critical steps in the manufacturing process.
  • Records should include information on raw materials, equipment, processing steps, in-process controls, and finished product testing.
  • Batch records must be reviewed and approved by authorized personnel before product release.
  • Any deviations or discrepancies observed during manufacturing must be documented, investigated, and resolved, with the results recorded in the batch records.
  • Batch records should be maintained in a manner that ensures data integrity, accuracy, and accessibility throughout the product lifecycle.
  1. PIC/S Guidance Documents:
  • PIC/S periodically releases guidance documents that provide additional clarification and interpretation of GMP requirements.
  • While these documents may not explicitly focus on batch manufacturing records, they often emphasize the importance of documentation and record-keeping in ensuring product quality and compliance with regulatory standards.
  1. PIC/S Inspections:
  • PIC/S members conduct inspections of pharmaceutical manufacturing facilities to ensure compliance with GMP standards.
  • During these inspections, inspectors assess the adequacy and accuracy of batch manufacturing records as part of their review of the overall quality management system.
  1. PIC/S Annexes:
  • Annexes to the PIC/S GMP Guide may provide specific requirements or recommendations related to documentation practices, which indirectly influence the content and format of batch manufacturing records.

Useful Links

  1. PIC/S Guide to Good Manufacturing Practice for Medicinal Products
  2. PIC/S Annexes to the GMP Guide

Therapeutic Goods Administration (TGA) of Australia:

The TGA Good Manufacturing Practice (GMP) Guidelines for Medicines requires comprehensive batch manufacturing records to be maintained, including details of all steps in the manufacturing process and quality control checks.

  1. Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990: The Therapeutic Goods Act and associated regulations outline the legislative framework for the regulation of therapeutic goods in Australia, including pharmaceuticals.

Key Takeaways:

  • Section 34 of the Therapeutic Goods Act requires manufacturers to maintain records of the production and testing of therapeutic goods, including batch manufacturing records.
  • Manufacturers must comply with the requirements outlined in the Therapeutic Goods Regulations regarding the content and maintenance of batch manufacturing records.
  1. Code of Good Manufacturing Practice for Prescription Medicines (GMP):
  • The TGA has adopted the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-13) as the basis for its GMP requirements.

Key Takeaways:

  • The TGA expects manufacturers to adhere to GMP principles, including those related to documentation and record-keeping.
  • Batch manufacturing records should be comprehensive and include detailed information on all stages of the manufacturing process, from receipt of raw materials to release of finished products.
  1. TGA Guidance Documents:
  • The TGA periodically publishes guidance documents to assist manufacturers in understanding and complying with regulatory requirements.
  • While these documents may not specifically focus on batch manufacturing records, they often provide guidance on documentation practices and record-keeping requirements.
  1. TGA Inspections and Audits:
  • The TGA conducts inspections and audits of pharmaceutical manufacturing facilities to assess compliance with GMP requirements.
  • During these inspections, TGA inspectors review batch manufacturing records to ensure they meet regulatory standards and reflect the manufacturing processes accurately.
  1. TGA Manufacturing Principles for Medicinal Products (PIC/S GMP):
  • The TGA aligns its GMP requirements with international standards, particularly those established by PIC/S.
  • Manufacturers should refer to PIC/S guidance documents, including the PIC/S Guide to Good Manufacturing Practice for Medicinal Products, for detailed guidance on batch manufacturing record requirements.

 Health Canada

  1. Good Manufacturing Practices (GMP) Guidelines - Version 2.0: Requires documentation of all critical steps in the manufacturing process, including batch records that provide a complete history of the batch.
  2. Food and Drugs Act and Food and Drug Regulations: The Food and Drugs Act and associated regulations provide the legislative framework for the regulation of drugs and other health products in Canada.
  • Key Takeaways:some text
    • Section C.02.012 of the Food and Drug Regulations requires manufacturers to maintain records of the production and testing of drugs, including batch manufacturing records.
    • Manufacturers must comply with the requirements outlined in the Food and Drug Regulations regarding the content and maintenance of batch manufacturing records.
  1. Good Manufacturing Practices (GMP) Guidelines for Drugs:
  • Health Canada has adopted GMP guidelines that align with international standards, such as those established by PIC/S.

Key Takeaways:

  • Manufacturers are expected to adhere to GMP principles, including those related to documentation and record-keeping.
  • Batch manufacturing records should be comprehensive and include detailed information on all stages of the manufacturing process, from receipt of raw materials to release of finished products.
  1. Health Canada Guidance Documents:
  • Health Canada periodically publishes guidance documents to assist manufacturers in understanding and complying with regulatory requirements.
  • While these documents may not specifically focus on batch manufacturing records, they often provide guidance on documentation practices and record-keeping requirements.
  1. Health Canada Inspections and Audits:
  • Health Canada conducts inspections and audits of pharmaceutical manufacturing facilities to assess compliance with GMP requirements.
  • During these inspections, Health Canada inspectors review batch manufacturing records to ensure they meet regulatory standards and accurately reflect the manufacturing processes.
  1. Parenteral Drug Association (PDA):
  • Technical Report No. 56 - Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
  • Provides guidance on data integrity principles, including the maintenance of accurate and complete batch manufacturing records.

Useful Links

Parenteral Drug Association (PDA)

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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

Emphasis

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