Get it Right the First Time: The Key to a Successful Regulatory Filing with Source Document Management and CTD Quality Module 3 Syncing

Mostly Manual until Recently

The process of creating the Chemistry, Manufacturing, and Controls (CMC) sections (CTD Quality Module 3) of any marketing application dossier is complicated and predominantly carried out manually (up until today!). It involves collecting information from the early stages of development to receiving Marketing Authorization and beyond. However, retrieving all the necessary information can be time-consuming, monotonous, and prone to errors when data is scattered across different areas of the organization and with external partners.

Centralization of data, digitalization, and automation can now simplify the process of CMC content authoring. Here we cover why this approach is the most effective solution to overcoming CMC dossier creation challenges. We will share how adopting an automated content authoring approach can elevate the quality and compliance of your CMC dossiers and foster collaboration during the document creation, review, and publication phases, all while reducing costs, expediting time-to-market, and increasing trust in your submissions.

The CMC dossier contains Critical Information about the Manufacturing Process and Quality Control of your Product

Developing a successful regulatory filing for your product can be daunting, especially regarding the CMC dossier. The CMC dossier contains critical information about your product’s manufacturing process and quality control, which regulatory authorities need to assess its safety, efficacy, and compliance. However, creating a CMC dossier is a complex and time-consuming process that requires collecting information from different sources and organizing it into a cohesive document.

Traditionally, creating CMC dossiers is a predominantly manual process that involves collecting data from different areas of the organization, including lab notes, test results, and quality control reports. This process is time-consuming, monotonous, and prone to errors, as the data is often scattered and unstructured. Additionally, creating CMC dossiers requires the collaboration of specialists who work on different sections of the same document, further complicating the process.

To address these challenges, organizations can digitize creating CMC dossiers. Digitizing the process involves centralizing data and automating document creation, making it faster, more efficient, and less prone to errors. By digitizing the process, organizations can streamline the creation of CMC dossiers, improve the document’s quality, and reduce the time and cost of creating and maintaining it.

One way to digitize the process of creating CMC dossiers is by using a structured document management system that can automate the creation and maintenance of documents. These systems can integrate data from different sources, including electronic lab notebooks, analytical instruments, and quality control systems. By combining data from these sources, these systems can create a structured and consistent document, eliminating the need for manual transcription.

Another advantage of using a structured document management system is that it can automate collaboration between specialists working on the same document. With a structured document management system, specialists can collaborate in real time, making it easier to share data and findings and reducing the time required to create and approve the document.

Using a structured document management system can also improve the quality and compliance of CMC dossiers. These systems can ensure that the document is consistent, accurate, and up-to-date, reducing the risk of regulatory non-compliance. By reducing the risk of regulatory non-compliance, organizations can expedite the approval process and get their products to market faster.

How Source Documents, e.g., Batch Records and Development reports can, be synced to their specific CTD Quality Module 3 Modules

In the pharmaceutical industry, it is common for batch records and development reports to be used as source documents for Chemistry, Manufacturing, and Controls (CMC) dossiers submitted to regulatory agencies. To ensure the accuracy and completeness of the CMC dossier, it is critical to have a process in place for syncing these source documents to their specific CTD Quality Module 3 modules.

The first step in this process is identifying which specific CTD Quality Module 3 modules are relevant to each source document. For example, batch records are typically used to provide information for the manufacturing process section of the CMC dossier. In contrast, development reports may support the nonclinical pharmacology and toxicology or clinical pharmacology sections.

Once the relevant CTD Quality Module 3 modules have been identified, the source documents should be reviewed to ensure that they contain all necessary information to support the specific module. Any missing information should be identified before syncing the source document to the module.

To sync the source document to the specific CTD Quality Module 3 module, the information from the source document should be organized and entered into the appropriate sections of the module. This may involve copying and pasting text or tables from the source document into the module or manually entering data into the appropriate fields.

Ensuring that the information entered into the CTD Quality Module 3 module is accurate and consistent with the source document is essential. Any discrepancies or errors should be identified and corrected before finalizing the module.

To facilitate the syncing process, many companies use electronic document management systems (EDMS) or other software solutions that allow for the seamless transfer of information between source documents and CTD Quality Module 3 modules. These systems can help to streamline the process and reduce the risk of errors or inconsistencies.

In summary, syncing source documents such as batch records and development reports to their specific CTD Quality Module 3 modules is a critical step in creating a successful regulatory filing for a pharmaceutical product. By following a systematic approach and using appropriate software solutions, companies can ensure the accuracy and completeness of their CMC dossiers and increase the likelihood of regulatory approval.

Some Examples, e.g., API process, Analytical Controls, Drug Product Stability

Let’s look closer at how source documents can be synced to specific CTD Quality Module 3 modules for different aspects of the CMC dossier, such as the API process, analytical controls, and stability.

3.2.S.2 The API Manufacturing Process

The manufacturing process section of the CMC dossier typically includes detailed information on the Active Pharmaceutical Ingredient (API) manufacturing process. The source documents for this section may consist of batch records, process development reports, and process validation reports. To sync these source documents to the specific CTD Quality Module 3 module, the information from the source documents should be entered into the appropriate sections of the module, including information on the raw materials used, equipment used, process parameters, and in-process controls.

From the Enkrisi CMC Module 3 Document Check List

3.2.S.4 The API Analytical Controls

The analytical controls section of the CMC dossier provides information on the methods used to test the quality of the product. Source documents for this section may include analytical method development reports, method validation reports, and stability data. To sync these source documents to the specific CTD Quality Module 3 module, the information from the source documents should be entered into the appropriate sections of the module, including details on the analytical methods used, specifications, and acceptance criteria.

From the Enkrisi CMC Module 3 Document Check List

3.2.P.8 The Drug Product Stability

The stability section of the CMC dossier provides information on the product’s stability over time and under various conditions. Source documents for this section may include stability study reports, including data on storage conditions, test methods, and results. To sync these source documents to the specific CTD Quality Module 3 module, the information from the source documents should be entered into the appropriate sections of the module, including details on the stability protocol, study design, and results.

In all cases, ensuring that the information entered into the CTD Quality Module 3 module is accurate, complete, and consistent with the source documents is essential. Any discrepancies or errors should be identified and corrected before finalizing the module. By syncing source documents to their specific CTD Quality Module 3 modules, companies can ensure that their CMC dossier is complete, accurate, and ready for submission to regulatory agencies.

From the Enkrisi CMC Module 3 Document Check List

The Process

The creation of CMC dossiers is a crucial part of any pharmaceutical product application to regulatory authorities such as the FDA. However, creating these dossiers is a time-consuming and intricate process that requires a significant amount of work.

Traditionally, CMC dossiers are created using unstructured data from multiple sources, including paper lab notes, resulting in discrepancies and lacking traceability. This manual transcription process is error-prone and requires verifying every data point to maintain data reliability.

Moreover, creating CMC dossiers is an ongoing process that can take up to 7000 hours, involving several specialists working on different document sections. The traditional system of sharing reports and documents via Google Docs, Dropbox, network drives, or email is insecure. It may lead to intellectual property theft or the inclusion of the wrong document version.

Our Process

Enkrisi offers a structured, automated, and collaborative approach to CMC document creation to address these challenges. Instead of static documents, data-centric automatic dossier creation using Enkrisi Structured Document Manager can integrate all the CMC dossier data, findings, and recommendations from other systems into one place.

This approach focuses on content rather than document preparation, improving quality, consistency, and accuracy. Organizations can ensure that their new submissions always contain the most up-to-date content, and users can access prior versions of data as well.

Enkrisi Structured Document Manager offers online document authoring, editing, sharing, and live referencing, enabling users to collaborate securely and in a controlled manner. Multi-channel publishing capabilities allow users to create documents in various formats, such as HTML, PDF, and Microsoft Word.

By automating document creation, organizations in the biopharma industry can produce CMC dossiers faster and more accurately, saving time and reducing manual verification by 30-70%. This approach can streamline the production and management of scientific and medical documents, resulting in lower prices, faster time-to-patient for life-saving medications, and faster NDA/MAA approvals from regulatory authorities.

Developing a successful regulatory filing for your pharmaceutical product requires a thorough and well-organized Chemistry, Manufacturing, and Controls (CMC) dossier. However, the traditional process of creating CMC dossiers is often a complicated and manual process that involves collecting information from various sources, both internally and externally.

The scattered nature of this information can make it challenging to retrieve all the necessary data, resulting in a time-consuming, monotonous, and error-prone process. To overcome these challenges, Enkrisi offers a structured, automated, and collaborative approach to CMC document creation.

Enkrisi’s Structured Document Manager centralizes data, digitizes the process, and automates the creation of CMC dossiers. This approach focuses on content rather than document preparation, ensuring improved quality, consistency, and accuracy. By automating the process, organizations can produce CMC dossiers faster and more accurately, saving time and reducing manual verification by 30-70%.

Moreover, Enkrisi’s Structured Document Manager offers online document authoring, editing, sharing, and live referencing, enabling secure collaboration among team members. This approach streamlines the production and management of scientific and medical documents, resulting in faster time-to-market and faster NDA/MAA approvals from regulatory authorities.

Adopting Enkrisi’s automated content authoring approach can significantly elevate the quality and compliance of your CMC dossiers while reducing costs and increasing trust in your submissions. By centralizing data and automating the process, organizations can ensure that their new submissions always contain the most up-to-date content, and users can access prior versions of data.

In Conclusion

Creating CMC dossiers is complicated and time-consuming, but with Enkrisi’s Structured Document Manager, organizations can simplify the process and achieve a successful regulatory filing. With a structured, automated, and collaborative approach to CMC document creation, organizations can produce higher-quality submissions faster, reduce costs, and ultimately get life-saving medications to patients more quickly.

Developing a successful regulatory filing for your product requires a well-organized and accurate CMC dossier. Creating a CMC dossier is complex and time-consuming, but it can be made more efficient by digitizing the process. By using a structured document management system, organizations can centralize data, automate document creation, and improve collaboration between specialists, resulting in higher quality, more compliant, and faster creation of CMC dossiers.