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SOP Manufacturing

Use this SOP Manufacturing template to establish a standardized process for transferring medical device designs and manufacturing activities between sites or from design to manufacturing. It is essential for ensuring regulatory compliance, product quality, and clear team responsibilities during manufacturing transfer, and should be completed whenever a product is moved to a new manufacturing location or introduced for initial production. This document is crucial for maintaining robust documentation, supporting regulatory submissions, and mitigating risks during manufacturing transitions.
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SOP Manufacturing

ID: Lorem ipsum dolor sit amet

1. Purpose

The purpose of this SOP is to define the procedure for initiation and completion of design and manufacturing transfer activities.

2. Scope

This procedure is applicable for transfer of products for:

2.1 Existing design to new manufacturing site

  • Lorem Ipsum Corp to Lorem Ipsum Corp Manufacturing site
  • Contract Manufacturer to Lorem Ipsum Corp
  • Contract Manufacturer to Lorem Ipsum Corp manufacturing Site
  • Contract Manufacturer to Contract Manufacturer

2.2 New Design to manufacturing

  • Lorem Ipsum Corp to Lorem Ipsum Corp Manufacturing
  • Lorem Ipsum Corp to Contract Manufacturer

If a project is started prior to the release of this revision, it may continue to be managed per its project plan and previous procedural requirements, unless the project team determines the revision addresses changes that need to be implemented within the project.

3 References

  • SOP Design Control
  • SOP Process Validation
  • SOP Supplier Management
  • SOP Nonconformance
  • Approved Supplier List

4 Responsiblities

4.1 Transfer Leader (Product team or similar team member)

  • Manages the interfaces between different functional groups to ensure effective communication and clear assignment of responsibilities
  • The Transfer Leader is the point person for transfer activities between sites
    • Responsible for the transfer project from initiation through to release to market
    • Has the ultimate responsibility for ensuring that systems/methods/documentation being transferred are compliant with the facilities internal and regulatory requirements
    • Conduct periodic transfer status reviews
    • Ensures that any issue met during the transfer are addressed and mitigated
    • Develops metrics to measure success of transfer, as needed

4.2 Product Team

  • Provides input to product review activity during manufacturability, risk assessment and identification of critical parameters. Participates and advises so that design and/or process intent is maintained
  • Provides specifications (process & product) as input into transfer
  • Responsible for creating part specifications and building bill of materials (BOM)

4.3 Quality Team

  • Provides input to product review activity during manufacturability, risk assessment and identification of critical parameters
  • Ensure validations are complete and approved
  • Ensure suppliers are qualified and supplier management processes are maintained
  • Ensure label proof is completed
  • Responsible for the maintenance of this device master record and ensuring that it is executed prior to manufacturing activities.

4.4 Manufacturing Engineering

  • Assesses the initial readiness for all transfers prior to team review
  • Responsible for build coordination with Supply chain
  • Reviews the accuracy of manufacturing processes and documentation
  • Reviews impact to other products and/or accessories
  • Updates the Device Master Record (DMR) as required

4.5 Manufacturing Site

  • Responsible for Training and Qualification
  • Responsible for build, testing, and data collection
  • Participates and advises so that output yield and/or intent is maintained

4.6 Supply Chain (Materials)

  • Provide the forecast and demand of the items required for transfer
  • Support build coordination
  • Ensure availability of components, including obsolescence status for validation activities

4.7 Regulatory Affairs

  • Reviews for consistency with the content of regulatory filings
  • Determine & advises team of the global regulatory impact of transfer activities and potential changes
  • Communicates the timeline of regulatory changes to the transfer team

5. Definitions

Transfer/Project Plan: A document that describes or references the product realization activities and defines the responsibility for implementation through commercial release. Identifies and describes the support interfaces with different groups or activities that provide, or result in, input to the transfer and/or development process.

Design History File (DHF): A compilation of documents or references to documents describing the development, Design Inputs, Outputs, Verification and Validation testing as well as Design Reviews and Design and Development Plans for Lorem Ipsum Corp products. The final, approved DHF is a controlled document.

Device Master Record (DMR): A complete compilation of records (or listing by reference) of the procedures and specifications required for manufacture of a Finished Device. The DMR answers "how" and to "what criteria" a product is manufactured. The DMR acts as a "pointer" to a catalog number or from product family to other related documents within the Quality System.

Manufacturing Transfer: The transfer of an existing product from one manufacturing location to another manufacturing location.

Transfer Leader: The person responsible for managing the transfer activities.

Manufacturing Process Document (MPD): A controlled instruction document that describes the process of manufacturing a particular assembly up to the finished good.

Bill of Materials (BOM): A bill of materials or product structure is a list of the raw materials, sub-assemblies, intermediate assemblies, sub-components, parts and the quantities of each needed to manufacture an end product.

6. Procedure

6.1

Manufacturing transfer activities are conducted with a phase-gate system that divides the effort of transfer into phases separated by a review. A transfer team must successfully complete a prescribed set of related cross-functional activities in each phase prior to proceeding to the next phase of product transfer.

6.2

For existing transfers, evaluate whether any intended changes are significant design changes per SOP-04 and require following the design control process outlined therein.

6.3

The Transfer Plan describes key phases and associated elements of transfer.

6.3.1

For Design Transfers of new designs, the Transfer Leader will determine if the Transfer Plan is included in the Project Plan for Design and Development.

6.3.2

Depending on the complexity of the project, the transfer plan may identify different deliverables for the activities identified in this procedure or additional phase reviews.

6.3.3

Elements of a Transfer Plan include, but are not limited to, identifying:

  • Scope (part numbers being transferred, and associated suppliers/manufacturing sites)
  • Team members, Resources (internal and external)
  • DHFs, Deliverables, schedule, and any key risks or dependencies
  • Supplier and inventory management strategy (if any)
  • Equipment (automated test equipment (ATE), measurement equipment, fixtures, etc) to be transferred, changed or developed, as needed
  • Manufacturing processes to be transferred, changed or developed, and any associated validations impacted
  • BOM obsolescence reports planned (scope & frequency), if needed

Reports (or review records) should include review of all PCBA or electrical components at minimum and for new designs, with each phase review starting at Design Output.

  • For existing designs, any evaluation of biocompatibility, bioburden/LAL, packaging/labeling and any other elements needed to determine equivalency of product from the new manufacturer.
  • For existing designs, initial regulatory assessment for all changes identified. For potential regulatory approvals, identify the associated requirements and timelines.
  • For projects updating existing SKUs, identify a planned final release/hold mechanism.

6.4

Final product release mechanisms include updating Finished Product Distribution List (if any), or releasing a Product Hold. For new product projects, review SOP Design Control's Market Release requirements.

6.4.1

For finished goods built at risk and held with a Product hold per SOP Nonconformance, product holds shall be initiated prior to final packaging.

6.5

Scheduled Phase reviews and approvals are held to review the progress of the transfer. Phase Review shall occur as follows:

6.5.1

Phase I Transfer Planning Review – A review of the transfer plan to ensure requirements for facilities, materials management strategy, manufacturing & test equipment, process validations (eg: sterilization, packaging, labeling, etc), regulatory requirements, and product equivalence evaluations (as required) are defined.

  • For Phase I reviews, an approved transfer plan serves as evidence to indicate the completion of phase.

6.5.2

Phase II Transfer Execution and Release Review – A review of the execution of transfer plan to ensure the milestones are achieved according to the plan.

  • Interim Reviews are held for situations where final assemblies/finished goods are to be built at risk (eg: prior to Market Release / Transfer Execution).
  • For transfers of existing designs, a final phase review authorizes to place products on the market.
  • For transfer of new designs, this review is part of clinical readiness, design validation and/or market release reviews to confirm sufficient design transfer activities have occurred such that units built can be used for clinical studies and/or as commercial units.
  • Team review are used to record review results and approval. Phase review attendees include the Transfer Leader, team members, stake holders, and an independent reviewer. A record of attendance is filed with the review meeting minutes.

6.5.3

After Transfer Execution and Release Review with cross-functional approval, the final release mechanism or product hold is then completed/released.

6.5.4

Post Transfer Reviews – Manufacturing, service level, and other quality metrics as established in the Transfer Plan or supplier agreement are regularly reviewed after transfer, as managed per SOP Supplier Management.

6.6

Transfer documents and records are stored or referenced in the respective design history file.

7.0 Device Master Record

The following guidelines should be followed for the technical documentation equivalent (DMR):

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