including FDA and ISO standards.

4) Procedure

4.1 Defining Batch and Lot Numbers
4.1.1 Batch and Lot Number System
– Establish a clear and consistent system for assigning batch and lot numbers. The system should include:
– Batch Numbers: Assigned to a specific production run or batch of medical devices.
– Lot Numbers: Assigned to individual units within a batch, typically used for traceability at the unit level.
– Ensure that batch and lot numbers are unique and sequential to avoid confusion between different production runs.
– Batch and lot numbers should be clearly identified and included on packaging labels.

4.1.2 Format of Batch and Lot Numbers
– Define the format for batch and lot numbers, which may include:
– Date of Manufacture: The year, month, and day of production.
– Product Code: A unique code to identify the specific medical device.
– Sequence Number: A unique number assigned to each batch or lot within a production run.
– Example: “2024-05-15-001” for batch produced on May 15, 2024, with a sequence number of 001.

4.1.3 Documentation of Batch and Lot Numbers
– Record all batch and lot numbers assigned to each production run and packaging batch in a centralized system.
– Maintain a Batch and Lot Tracking Log to document the following information:
– Batch or lot number.
– Production date.
– Quantity of units produced.
– Packaging materials used.
– Operator or team responsible for packaging.

4.2 Packaging and Labeling with Batch and Lot Numbers
4.2.1 Packaging Labeling
– Ensure that all packaging includes clear and visible batch or lot numbers, which may appear on:
– Primary packaging (e.g., blister packs, pouches).
– Secondary packaging (e.g., cartons, boxes).
– Shipping labels.
– Instructional or informational inserts.
– Use barcodes or QR codes when appropriate to enable automated tracking and scanning of batch or lot numbers.

4.2.2 Recording and Verifying Batch and Lot Numbers
– The manufacturing team must verify that batch and lot numbers are correctly applied to packaging materials before sealing and final inspection.
– Ensure that the batch and lot numbers on the packaging match the records in the Batch and Lot Tracking Log.

4.3 Traceability and Record Keeping
4.3.1 Traceability System
– Implement a system to track each medical device or batch of devices from production to distribution:
– Use a digital or paper-based traceability system to link batch and lot numbers to production records.
– Track the movement of devices from packaging through shipping, storage, and distribution channels.

4.3.2 Batch and Lot Traceability during Distribution
– Ensure that batch and lot information is transferred with the product during shipping, including:
– Shipping documents (e.g., packing lists, invoices).
– Inventory management systems.
– Distributor and retail records.

4.3.3 Record Retention
– Retain records of batch and lot numbers for a minimum of five years or as required by regulatory authorities.
– Maintain traceability records, including:
– The associated batch/lot number.
– Shipping, handling, and distribution records.
– Any incidents or recalls linked to specific batches or lots.

4.4 Managing Recalls and Corrective Actions
4.4.1 Product Recall Procedures
– In the event of a product recall, traceability systems should allow for the quick identification and retrieval of affected batches or lots.
– The following steps should be taken:
– Immediate Identification of Affected Batches/Lots: Identify all devices within affected batches or lots using the batch/lot traceability records.
– Customer Notification: Notify customers, distributors, and any affected parties with clear instructions on how to return or dispose of the affected product.
– Inventory Checks: Conduct inventory checks of warehouses and distribution channels to identify and remove recalled products.

4.4.2 Corrective Actions and CAPA
– Investigate the root cause of any issues related to batch or lot numbers and implement corrective actions as needed:
– Review packaging processes and production practices.
– Implement corrective actions to prevent recurrence, such as retraining personnel or modifying production processes.

4.5 Compliance and Regulatory Requirements
4.5.1 Compliance with FDA and ISO Standards
– Ensure that batch and lot traceability processes comply with regulatory standards, such as:
– FDA 21 CFR Part 820: Medical Device Packaging and Labeling Requirements.
– ISO 13485: Quality Management Systems for Medical Devices.
– ISO 9001: Quality Management Systems (if applicable).

4.5.2 Regulatory Inspections and Audits
– During regulatory inspections or audits, provide all batch and lot traceability records, including:
– Batch production and packaging records.
– Shipping and distribution records.
– Records of any product recalls or corrective actions related to specific batches or lots.

4.6 Documentation and Record Keeping
4.6.1 Batch and Lot Tracking Log
– Maintain a centralized Batch and Lot Tracking Log that includes the following information:
– Batch and lot numbers.
– Production dates and shifts.
– Quantity produced and packaged.
– Packaging and labeling records.
– Operator and supervisory approvals.

4.6.2 Record Retention
– Ensure all batch and lot records are stored securely and are retrievable for audit purposes.
– Retain batch and lot records for at least five years, or as required by local regulatory authorities.

4.7 Continuous Improvement and Auditing
4.7.1 Monitoring and Auditing
– Regularly monitor and audit the batch and lot traceability system to ensure compliance with internal procedures and regulatory requirements.
– Perform regular checks on traceability records and packaging processes.
– Conduct internal audits to verify that batch and lot tracking is consistent and accurate.

4.7.2 Continuous Improvement
– Use the results of audits, customer feedback, and post-market surveillance to identify areas for improvement in batch and lot traceability processes.
– Implement corrective and preventive actions (CAPA) as necessary to address any issues identified.

5) Abbreviations

– QA: Quality Assurance
– SOP: Standard Operating Procedure
– FDA: Food and Drug Administration
– ISO: International Organization for Standardization
– CAPA: Corrective and Preventive Actions

6) Documents

– Batch and Lot Tracking Log
– Batch Production and Packaging Records
– Corrective Action and CAPA Records
– Regulatory Compliance Audits

7) Reference

– FDA CFR Title 21, Part 820: Quality System Regulation
– ISO 13485: Medical Devices – Quality Management Systems
– ISO 9001: Quality Management Systems

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Batch and Lot Tracking Log Template

Batch/Lot Number	Production Date	Quantity Produced	Operator	Packaging Team	Approval Status
2024-05-15-001	DD/MM/YYYY	1000 units	John Doe	Packaging Team A	Approved

Annexure 2: Corrective Action Log Template

Date	Action ID	Issue Description	Corrective Action Taken	Responsible Person
DD/MM/YYYY	CA-001	Batch labeling error	Re-trained staff, updated labeling procedure	Training Coordinator