Change Packet

A compilation of documentation for a change, which includes detailed explanations from the assessment of scope, impact, associated risks, tasks, and actions to be taken, along with supporting evidence. This packet needs to be reviewed and approved by every involved department.

A Change Packet is the required evidence folder that tells the complete story of a revision, ensuring that the change is safe, effective, and compliant before it is implemented. This packet aggregates the documentation generated during the Change Assessment and Change Control Process and is mandated by regulations like the FDA's Quality System Regulation (21 CFR Part 820)

Core Components of the Change Packet

The documents within this packet are necessary to fulfill the procedural requirements for modifying a product, process, or document (often referred to as Design Changes or Production/Process Changes). This collection typically must include:

Identification and Description of the Change:

The packet begins with formal documentation (e.g., an Engineering Change Request or a Change Notice) that describes the proposed alteration.

Review and Approval Records:

Documentation must be included to show that authorized personnel reviewed and approved the change before implementation. Changes must generally be reviewed and approved by the same functions or organizations that conducted the original review, unless otherwise designated.

Justification and Rationale:

The packet must clearly state the reason for submitting the amendment or change. For PMA supplements, a full explanation of the basis for the changes is required.

Impact Assessment and Verification/Validation:

Documentation must demonstrate that the change will not negatively affect the product's quality, safety, or effectiveness. This often requires including records of verification or validation activities performed on the modification prior to implementation.

Affected Documents and Records:

The packet must identify the documents and items affected by the change. For documents, the records of change must include identification of affected documents, the approving signature(s), the approval date, and the effective date of the change.

Change Packet in Regulatory Submissions

In heavily regulated industries, the "Change packet" functions as the official submission to the regulatory body for approval of a modification:

Premarket Approval (PMA) Supplements:

These formal supplements function as a change package and are required before making any change to a Class III device that affects its safety or effectiveness. The required information is limited to what is needed to support the specific change being requested.

Investigational Device Exemptions (IDE) Supplements:

Changes to an investigational plan require approval of a supplemental application, and the notice must include a summary of the relevant information gathered during the investigation upon which the change was based.

Tobacco Product Applications:

For tobacco products, supplements, or resubmissions, new information regarding modifications must be provided, often cross-referencing the original application content, ensuring a complete and justified packet is submitted for review.

The overall purpose of collecting this comprehensive Change Packet documentation is to satisfy the fundamental QMS and regulatory requirements to prevent the use of obsolete documents and to ensure revision control throughout the product lifecycle.

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