This blog covers:
- An overview of product-specific documents
- Product-specific documents vs. CCDS
- Practical applications in pharmacovigilance
Table of Contents
Introduction
Many case processors are known to refer to multiple documents during case processing. However, two documents in particular are especially important and should be verified frequently while a case is being handled.
Despite their significance, many are unaware of the crucial differences between the two and often assume they are the same.
This article aims to clarify the distinction between them, that is product specific document and CCDS.
Product Guidance Document: An Overview
A Product Specific Document is a key reference that should be available for every pharmaceutical product. The responsibility for creating and maintaining this document lies with the Marketing Authorization Holder (MAH).
Within pharmacovigilance, this document serves as an essential source of verification and reference during case processing, ensuring accuracy and compliance throughout the workflow.
“Clarity in documentation is the foundation of accuracy in pharmacovigilance—knowing the difference between product-specific documents and the CCDS ensures safer, more reliable case processing.”
Components of a Product Guidance Document
While a Product Guidance Document may contain several details, its key components typically include:
What is this document about:
- Dynamic properties of the product
- Product-specific conventions
- Coding conventions for case processing
- Guidance on handling special events
- Approved indications
- Contraindications
- Clarifications for product-related queries during case processing
- Dosing information – essential for assessing overdose, underdose, misuse, medication errors, off-label use, etc.
- Practical guidance to improve the quality and consistency of case processing
A Product Guidance Document is not intended for:
- Determining listedness
- Assessing causality
- Primarily referencing warnings and precautions
- Evaluating expectedness
- Serving as a general case processing reference
- Defining overall case conventions
Product Guidance Document vs. CCDS
Product Guidance Document
The Product Guidance Document is a practical reference tool developed and maintained by the Marketing Authorization Holder (MAH). Its primary purpose is to support case processors in the pharmacovigilance department.
It contains product-specific instructions, conventions, dosing information, approved indications, contraindications, and clarifications for handling special situations. By serving as a quick-access guide, it helps ensure that case processing is consistent, accurate, and aligned with regulatory expectations.
In short, it is a working document designed to assist professionals (pharmacovigilance) in their day-to-day activities.
CCDS (Company Core Data Sheet)
The Company Core Data Sheet (CCDS) is a comprehensive safety reference document prepared by the pharmaceutical company. Unlike the Product Guidance Document, the CCDS is a regulatory and scientific document that consolidates essential safety and efficacy information for a drug.
It typically includes pharmacological details, pharmacokinetic and pharmacodynamic properties, results from clinical trials, post-marketing data, indications, contraindications, warnings, and precautions.
The CCDS forms the basis for local labeling documents, such as the Prescribing Information (PI) or Summary of Product Characteristics (SmPC), and is a key reference for regulatory submissions worldwide.
Its primary role in pharmacovigilance is to determine listedness, expectedness, and to guide safety assessments.
Key Difference
While both documents are important, their purpose and use are distinct:
- The Product Guidance Document is primarily an operational tool for case processing within pharmacovigilance.
- The CCDS is a regulatory safety document that serves as the company’s central source of product safety information.
Know the Document, Improve the Process—Here’s How.
Accuracy is everything
A single oversight in case processing can lead to misinterpretation, delays, or even regulatory non-compliance. At Drugvigil, we understand every nuance of case processing in pharmacovigilance.
Key Takeaways
When information is not available in the Product Guidance Document, the CCDS should be consulted.
The CCDS compiles all critical study data and safety information.
Both documents are essential references for ensuring completeness and accuracy in case processing.
Each document is subject to revisions and updates as new information becomes available.
Conclusion
This article has outlined the purpose of product-specific guidance documents and clarified how they differ from the Company Core Data Sheet (CCDS). Since both are vital resources in pharmacovigilance, understanding their roles and knowing when to use each is key to maintaining quality and compliance in case processing.
We hope this article has provided you with valuable insights. If you found it helpful, feel free to share it with your colleagues—whether they are beginners or experienced professionals. Thank you for reading.
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