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Lot number

A lot number is a unique alphanumeric identifier assigned to a specific batch or group of products manufactured, processed, or packaged under uniform conditions, enabling traceability of the complete production history from raw materials to distribution.^[1] In regulated industries such as pharmaceuticals, food, and for certain critical medical devices, lot numbers—often interchangeable with batch or control numbers—facilitate quality assurance by allowing manufacturers to track items through the supply chain, identify defects, and execute targeted recalls if contamination or issues arise.^[1]^[2] For instance, under U.S. Food and Drug Administration (FDA) regulations, a lot number must consist of distinctive letters, numbers, or symbols that permit determination of the full manufacturing, processing, packing, holding, and distribution history of the batch.^[1] This traceability is critical for compliance with current good manufacturing practices (cGMP), where a lot represents a batch or portion thereof with uniform character and quality within specified limits.^[1] Beyond regulatory requirements, lot numbers support inventory management and risk mitigation in broader manufacturing contexts, helping to isolate faulty products without disrupting unrelated stock.^[3] In the food sector, for example, the FDA's traceability lot code (TLC)—a type of lot identifier—is assigned at key points like initial packing of raw agricultural commodities or transformation processes, ensuring rapid identification of sources during outbreak investigations.^[3] Similarly, in dietary supplements, lot numbers link to records for verifying compliance with safety standards.^[4] The format of lot numbers varies by industry and manufacturer but typically includes elements like production date, facility code, or sequential batch identifiers to enhance specificity and avoid duplication.^[1] International standards, such as those from the International Organization for Standardization (ISO) in quality management systems like ISO 9001, emphasize the use of such identifiers for product identification and traceability without prescribing a rigid format, allowing flexibility while mandating unique distinguishability.^[5] Effective implementation of lot numbering not only meets legal obligations but also minimizes economic losses from recalls by enabling more targeted actions.^[3]

Fundamentals

Definition

A lot number is a unique alphanumeric identifier assigned to a discrete batch or quantity of identical products or materials produced under uniform conditions by a single manufacturer. This identifier enables the determination of the complete manufacturing history of the batch, distinguishing it as a tool for grouping items sharing the same production parameters, such as raw materials, processes, and time frame. Unlike serial numbers, which provide a unique identifier for each individual item within a production run to track its specific history or warranty, lot numbers serve as group identifiers for all items in a batch produced together, facilitating collective management without item-level granularity.^[6] This differentiation is crucial in manufacturing, where lot numbers apply broadly to batches while serial numbers enable precise, one-to-one tracking for high-value or regulated goods.^[7] Typically, lot numbers appear as simple textual or printed alphanumeric labels on product packaging, such as "LN12345" etched or stamped directly on containers or tags.^[8] Lot numbers play a key role in quality control by enabling traceability of production batches.^[9]

Purpose

Lot numbers serve as unique identifiers for batches of products produced under similar conditions, enabling comprehensive traceability of production elements such as raw materials, ingredients, parts, labor, and equipment used in manufacturing. This traceability is essential for quality assurance, allowing manufacturers to isolate defects or non-conformities to specific lots without affecting unrelated production runs, thereby maintaining overall process integrity. According to the U.S. Food and Drug Administration (FDA), lot numbers facilitate the tracking of devices from production to end-use, supporting failure investigations and ensuring compliance with quality system regulations under 21 CFR 820.65. Similarly, in food production, traceability lot codes link key data elements across the supply chain, aiding in the precise identification of affected batches during safety assessments. Throughout the product lifecycle, lot numbers play a critical role in determining expiration dates by associating batches with specific production timelines and storage conditions, which informs inventory management and rotation to prevent spoilage or obsolescence. They also enable efficient product recalls by delineating the scope of affected items, allowing regulators and manufacturers to target only contaminated or defective lots rather than entire product lines. The FDA emphasizes that traceability lot codes help determine recall boundaries and link products to handling firms, expediting responses to outbreaks or quality issues as outlined in the Food Safety Modernization Act (FSMA) final rule. In the food sector, this capability reduces the time required to isolate sources of contamination, such as in cases of Salmonella or Listeria, minimizing broader distribution risks. For consumers and public health, lot numbers provide a mechanism to investigate product origins in incidents like foodborne illnesses, enabling end-users to contact manufacturers for verification or return affected items. This empowers rapid reporting to authorities, facilitating investigations into contamination sources and preventing further harm. The U.S. Department of Agriculture's Economic Research Service highlights that traceability systems, including lot numbering, support traceback for food safety, allowing quick isolation of unsafe products and targeted recalls to protect public health. Economically, lot numbers reduce waste and liability costs by enabling precise accountability at the batch level, avoiding unnecessary disposal of unaffected inventory and limiting recall expenses, which can average $10 million per incident without effective tracking. The USDA reports that enhanced traceability lowers supply chain costs, including inventory holding and recall-related losses, by improving efficiency and reducing the scope of interventions in high-risk scenarios.

Components and Format

Typical Elements

Lot numbers typically consist of several common structural components that enable identification and tracking of production batches across manufacturing processes. These include a manufacturer identifier, such as a code representing the producing company or facility; date codes indicating the production timeframe, such as Julian dates (ordinal day of the year) or week-year formats (e.g., YYWW for year and week number); plant or production line identifiers to specify the manufacturing location or assembly line; and sequential batch numbers that uniquely distinguish one production run from another within the same facility or period.^[10]^[11]^[12] There is no universal standard format for lot numbers, allowing variation by manufacturer and industry while ensuring uniqueness.^[12] Encoding practices in lot numbers often incorporate timestamps, such as day or hour details, particularly in high-precision manufacturing environments to narrow down production windows for enhanced traceability. Alphanumeric schemes are commonly employed to compactly encode multiple data points, allowing a single string to convey manufacturer details, temporal information, and batch specifics without excessive length.^[10]^[11]^[13] The length of lot numbers generally ranges from 4 to 20 characters, balancing compactness with the need for unique identification; this format supports machine readability through integration with barcodes or RFID tags, while remaining legible for human scanning during inventory checks or quality audits. These elements collectively facilitate batch traceability, enabling quick recall or investigation if issues arise.^[9]^[12]^[11] For instance, a hypothetical lot number like "ABC-2025-045-001" can be parsed as follows: "ABC" for the manufacturer identifier, "2025-045" representing the year and week of production, and "001" denoting the specific production line or sequential batch.^[10]^[13]

Variations Across Industries

In the manufacturing sector, particularly electronics and textiles, lot numbers are adapted to emphasize production line codes and material sourcing identifiers for enhanced traceability of complex assembly processes. In electronics manufacturing, these codes typically include details on the specific production line, shift, and raw material batches, such as wafer lots for semiconductors, to isolate defects to particular equipment or suppliers.^[14]^[11] In textiles, lot numbers prioritize dye lot identifiers, which specify batches processed in the same dyeing vat to maintain color consistency across fabrics.^[15] Food and agriculture industries modify lot numbers to incorporate harvest dates or supplier codes, enabling rapid tracking of perishables like meat and produce through the supply chain. For produce, these codes often feature Julian dating for the harvest day—such as 120 for April 30—alongside identifiers for fields, farms, or packers to pinpoint origins and conditions.^[16]^[17] In meat processing, traceability lot codes often include packing dates in formats like MM/DD/YYYY along with facility and product identifiers to trace animal sources and processing runs.^[18] Cosmetics and consumer goods employ shorter lot number formats that focus on expiration proximity, typically integrating manufacturing or shelf-life dates with UPC barcodes for efficient retail and recall management. Common structures use compact notations like YYMM followed by a batch letter or number—such as 2507A for July 2025—to indicate production timing without requiring explicit expiration labels on long-shelf-life items.^[19]^[20] These variations reflect sector-specific priorities: perishables in food and agriculture favor date-heavy codes for freshness monitoring, whereas manufacturing in electronics and textiles stresses equipment and sourcing details for quality control.^[12] Building on shared typical elements like basic date codes, such adaptations ensure lot numbers align with operational demands without standardizing across all industries.^[13]

Applications

Manufacturing and Supply Chain

In manufacturing processes, lot numbers are assigned at the start of each production batch to uniquely identify and track raw materials and components from receipt through assembly and final output, enabling full traceability of the production history. This practice aligns with quality management standards like ISO 9001 Clause 8.5.2, which requires organizations to use suitable means, such as lot numbering, to identify outputs during production and ensure their status is known throughout the process.^[5] By linking lot numbers to specific batches, manufacturers can monitor transformations and isolate any issues arising from material inputs or processing steps, thereby supporting operational efficiency and defect prevention.^[12] Within the supply chain, lot numbers enhance reverse logistics by connecting finished products back to their originating supplier batches, streamlining the handling of returns and warranty claims through precise identification of potentially faulty items. This linkage allows for quicker resolution of customer issues and reduces the scope of investigations into product origins, as lot data can reveal upstream supply details without disrupting unrelated inventory flows.^[12] For example, if a returned item is flagged under warranty, the associated lot number facilitates verification against supplier records, enabling targeted repairs or replacements rather than broad interventions.^[21] Lot numbers integrate seamlessly with Enterprise Resource Planning (ERP) systems to provide granular inventory control, tracking stock levels at the batch level and enforcing First-In, First-Out (FIFO) rotation to optimize material usage and prevent stock obsolescence. In ERP environments, each lot is monitored for quantity, location, and expiration or shelf-life attributes, allowing automated alerts for low stock or aging batches to maintain accurate inventory valuation and turnover rates.^[12] This batch-level visibility supports just-in-time manufacturing by ensuring older lots are prioritized for use or shipment, minimizing holding costs and waste across the supply chain.^[22] A general example of lot numbers' impact in electronics manufacturing involves a defective batch of integrated circuits identified post-assembly due to intermittent failures; by tracing the lot number assigned at the component sourcing stage, the manufacturer isolated and recalled only the affected units from distribution channels, averting broader market disruptions.^[23] This targeted approach, enabled by lot traceability, underscores how such systems contain recalls to specific batches, preserving supply chain integrity and customer trust.

Pharmaceuticals and Food Safety

In the pharmaceutical industry, lot numbers are mandatory on drug labels to enable comprehensive tracking of batches throughout their lifecycle, allowing manufacturers, regulators, and healthcare providers to monitor product efficacy, stability, and potential adverse events. According to FDA regulations under 21 CFR 201.18, lot numbers must yield the complete manufacturing history of a package, facilitating investigations into batch-specific issues such as deviations in stability testing, where multiple lots are evaluated per ICH Q1A guidelines to ensure consistent potency and purity over time. For adverse event reporting, lot numbers are required in submissions to systems like the FDA Adverse Event Reporting System (FAERS), enabling linkage to clinical trial data and post-market surveillance to identify patterns in specific batches, as outlined in 21 CFR Part 600 Subpart D.^[24] In the food industry, lot numbers play a pivotal role in outbreak response by identifying and isolating contaminated batches, thereby expediting recalls and limiting exposure. For instance, during the 2018 multistate E. coli O157:H7 outbreak linked to romaine lettuce, which sickened 210 people and caused five deaths, traceability efforts relied on lot codes and harvest records to trace contamination back to specific growing regions in Yuma, Arizona, although incomplete coding initially necessitated a nationwide recall.^[25] Under the FDA's Food Safety Modernization Act (FSMA), traceability lot codes uniquely identify batches for rapid response, as defined in the traceability rule, allowing authorities to quarantine affected products and prevent further distribution.^[3] Lot numbers serve as the foundation for serialization extensions in both sectors, enhancing anti-counterfeiting measures by combining with unique serial numbers. In the United States, the Drug Supply Chain Security Act (DSCSA) mandates that product identifiers include the National Drug Code (NDC), lot number, expiration date, and serial number on prescription drug packages to verify authenticity and enable interoperable tracing, with full enforcement phases concluding in late 2025 for dispensers.^[26]^[27] This serialized approach builds on lot-level tracking to combat diversion and falsified medicines, reducing risks in the supply chain. The public health impact of lot numbers is profound, as effective traceability significantly improves recall efficiency by confining actions to contaminated batches, thereby reducing the affected distribution scope and associated costs. Studies indicate that robust lot traceability can lower recall expenses by up to 70% compared to systems lacking such precision, by enabling targeted isolation rather than broad market withdrawals, which minimizes waste and exposure in both pharmaceutical and food contexts.^[28]

Automotive and Other Sectors

In the automotive industry, lot numbers are essential for tracking components such as engines, tires, and airbag inflators, enabling precise identification during safety recalls. These identifiers are assigned to batches of parts during manufacturing to maintain traceability from suppliers to final assembly, often integrated with vehicle systems for comprehensive recall management. For instance, in the Takata airbag crisis, which led to the recall of over 67 million airbags worldwide, affecting more than 40 million vehicles, lot numbers on propellant batches allowed regulators and manufacturers to pinpoint defective inflators produced under specific conditions, facilitating targeted replacements and preventing further ruptures that caused fatalities.^[29]^[30]^[31] Although lot numbers for parts are distinct from the Vehicle Identification Number (VIN), which uniquely identifies the entire vehicle, they complement VIN data in recall processes by linking component batches to specific production runs. This integration supports regulatory compliance under standards like those from the National Highway Traffic Safety Administration (NHTSA), where VIN lookups combined with part lot details expedite notifications to owners.^[32] In aerospace and defense sectors, lot numbering provides high-security traceability for critical components, ensuring accountability from certified suppliers through rigorous quality controls. Components such as fasteners, alloys, and avionics are marked with lot or batch numbers to comply with standards like AS9100, which mandates full documentation of serial and lot identifiers for every assembly to enable root-cause analysis in case of failures. This system allows manufacturers to trace materials back to their origins, verifying compliance with supplier certifications and mitigating risks in high-stakes environments like aircraft engines or missile systems.^[33]^[34]^[35] Beyond transportation, lot numbers play key roles in electronics for managing warranty batches and in textiles for supporting ethical sourcing audits. In electronics manufacturing, lot codes on items like smartphone motherboards determine warranty eligibility and streamline repair logistics by identifying production batches prone to defects, allowing companies to isolate issues without recalling entire product lines.^[36] In the textile industry, lot numbers facilitate traceability of dye lots and materials, aiding audits that verify ethical practices such as fair labor and sustainable sourcing by linking products to supplier records and production origins.^[37]^[38] A historical example of lot numbers ensuring munitions accountability appears in British artillery shells from World War II, where markings including lot numbers on cartridge cases and packaging enabled sorting by manufacturing batches for inventory control and malfunction investigations. These identifiers, often combined with single-letter codes for fillers, supported precise tracking of ammunition lots, preventing misuse and facilitating accountability in supply chains during wartime production.^[39]^[40]

Regulatory Framework

International Standards

International standards for lot numbers emphasize uniform identification and encoding practices to facilitate global traceability in supply chains. The International Organization for Standardization (ISO) plays a key role through ISO 15394:2017, which specifies requirements for bar codes and two-dimensional symbols on packaging labels for shipping, transport, and receiving. Complementing this, ISO 22000:2018 establishes food safety management systems that mandate traceability mechanisms, requiring organizations to uniquely identify lots of products and materials to trace forward and backward through the supply chain for contamination control and recall efficiency. The GS1 system provides a globally adopted framework for extending Global Trade Item Numbers (GTINs) with lot-specific data, using standardized Application Identifiers such as AI 10 for batch or lot numbers in bar codes like GS1-128, ensuring interoperability across international supply chains for efficient inventory and quality tracking. The World Health Organization (WHO) issues guidelines promoting robust batch numbering in pharmaceuticals to support international trade and mitigate substandard drugs, defining a batch number as a unique alphanumeric identifier on labels, records, and certificates of analysis to verify authenticity and enable rapid traceability during global distribution. Despite these frameworks, harmonization challenges persist due to varying national interpretations and legacy systems, prompting 2020s digital initiatives like GS1's integration of lot number data into blockchain and EPCIS (Electronic Product Code Information Services) for real-time, standardized cross-border visibility, as outlined in their 2020 guidelines on applying GS1 standards to blockchain applications.^[41]

National Regulations

In the United States, the Food and Drug Administration (FDA) mandates the use of lot or control numbers on drug product labels under 21 CFR Part 211, Subpart G, to enable the determination of the manufacture and control history of each batch, facilitating effective recalls and quality assurance. This requirement is part of the Current Good Manufacturing Practice (CGMP) regulations, which ensure that drug products are identifiable throughout their lifecycle. Following the enactment of the Drug Supply Chain Security Act (DSCSA) in 2013 as Title II of the Drug Quality and Security Act, manufacturers of prescription drugs must implement serialization, incorporating the lot number alongside the National Drug Code (NDC), a unique serial number, and expiration date on packaging to enhance supply chain traceability and prevent counterfeit drugs.^[42]^[26] In the European Union, Regulation (EU) No 1169/2011 on the provision of food information to consumers requires food business operators to ensure accurate labeling, including lot identification where necessary for traceability, particularly to support rapid allergen recalls by isolating affected batches. This complements the broader traceability obligations under Regulation (EC) No 178/2002, which mandates that food and feed operators maintain records of lot numbers to trace products from one business to the previous and next, enabling swift withdrawal or recall in cases of contamination or undeclared allergens.^[43] Lot marking on prepacked foodstuffs is further specified in Directive 2011/91/EU, ensuring that batches can be uniquely identified for enforcement and consumer safety. Other nations have established similar national mandates tailored to their regulatory frameworks. In China, the National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), requires lot or batch numbers on pharmaceutical labels and packaging under Good Manufacturing Practice (GMP) guidelines to track production and distribution, with records retained for periods ranging from 1 to 10 years depending on the product type and shelf life.^[44] In Canada, Health Canada enforces lot number requirements through the Food and Drug Regulations, mandating that importers and manufacturers retain samples of each drug lot for at least one year beyond the expiry date to support investigations and recalls.^[45] Non-compliance with these national lot number regulations can result in significant enforcement actions. In the US, FDA violations, such as misbranding due to absent or incorrect lot numbers, may lead to civil monetary penalties up to $500,000 per violation for corporations, product seizures, injunctions, or facility shutdowns, particularly if they hinder effective recalls.^[46] In the EU, penalties vary by member state but include fines up to €100,000 or more for serious traceability failures affecting public health, along with product withdrawals.^[47] China's NMPA imposes administrative fines of 3 to 10 times the illegal gains from the violation (or up to RMB 100,000 if no gains), with higher penalties up to 20 times gains or CNY 50 million for serious violations as of 2025, license suspensions, or market bans for labeling violations.^[48]^[49] while Health Canada can issue fines up to $5 million under the Food and Drugs Act, coupled with license revocations or import bans for GMP breaches involving lot tracking.

Implementation and Technology

Generating and Assigning Lot Numbers

The generation of lot numbers typically occurs at the initiation of a production batch, where manufacturing execution systems (MES) or enterprise resource planning (ERP) software employ algorithms to automatically create unique identifiers by combining predefined elements such as production timestamps, sequential counters, and product codes.^[50]^[51] For instance, formats may incorporate tags like year (YY), month (MM), day (DD), and an incrementing index to ensure differentiation across batches.^[50] In continuous production processes, initial identifiers might use a product code paired with date and time until a final lot number is allocated upon completion.^[52] Assignment of lot numbers follows generation and involves applying the identifier to the batch through physical or digital means, such as printing on labels, laser etching on components, or embedding in digital records during material transactions.^[52]^[53] Rules for sequential uniqueness are enforced within facilities by incrementing counters or indices tied to the production order, preventing overlaps and enabling traceability from raw materials to finished goods.^[50]^[51] Best practices emphasize the use of centralized databases within ERP or MES platforms to avoid duplicates by validating new lot numbers against existing records in real time.^[12] In multi-site production environments, prefixed identifiers—such as a site-specific code followed by the core lot sequence—facilitate global uniqueness and simplify cross-facility management.^[54] MES tools play a critical role in real-time assignment by integrating lot generation with production workflows, allowing operators to create and apply numbers directly via interfaces during order execution, often synchronizing with upstream ERP systems for validation.^[51]^[50] This automation reduces manual errors and ensures compliance with traceability requirements across industries.^[52]

Tracking and Traceability Systems

Tracking and traceability systems enable the monitoring of lot numbers throughout the supply chain, providing visibility from production to end-user consumption. These systems leverage advanced technologies to ensure accurate, real-time data capture and retrieval, facilitating compliance, quality control, and rapid response to issues. Radio Frequency Identification (RFID) technology plays a central role in lot tracking by attaching tags to products or pallets, allowing automated identification and location monitoring without line-of-sight scanning. RFID enables real-time visibility into lot movements, reducing manual errors and supporting traceability from manufacturing facilities to distribution points.^[55] When integrated with Internet of Things (IoT) sensors, RFID collects environmental data such as temperature or humidity alongside lot identifiers, enhancing traceability for perishable goods in sectors like food and pharmaceuticals.^[56] Blockchain complements RFID and IoT by creating immutable digital ledgers for lot data, ensuring tamper-proof records shared across supply chain participants. This distributed approach verifies lot provenance at each handover, from factory to consumer, minimizing fraud and enabling verifiable audits.^[57] IoT devices, including smart sensors and gateways, feed live data into blockchain networks, supporting end-to-end tracking while maintaining data integrity through cryptographic hashing.^[58] Systems integration links lot numbers to Enterprise Resource Planning (ERP), Warehouse Management Systems (WMS), and broader supply chain software, creating unified platforms for comprehensive visibility. ERP solutions embed lot data into inventory modules, automating updates across procurement, production, and sales processes to track material flows precisely.^[12] WMS integration synchronizes lot information with storage locations and shipment records, enabling real-time queries and reducing discrepancies between physical stock and digital records.^[59] This connectivity extends to third-party logistics software, fostering collaborative traceability among suppliers, manufacturers, and retailers. Recall execution relies on database algorithms that query lot numbers to isolate affected batches swiftly. Upon identifying a defect, systems scan centralized databases using lot codes as primary keys, retrieving associated records on locations, quantities, and stakeholders within seconds.^[60] Notification protocols then automate alerts to distributors and customers via integrated communication tools, limiting recall scope to contaminated lots and preventing broader market disruptions.^[3] Such querying mechanisms, often powered by SQL-based relational databases, ensure compliance with recall guidelines by providing audit trails of actions taken. Emerging trends in traceability include AI-driven predictive analytics, which forecast potential lot-related risks by analyzing historical data patterns and supply chain variables. These systems use machine learning models to anticipate disruptions, such as contamination risks, enabling proactive interventions before issues escalate.^[61] As of 2025, AI adoption across organizations has reached 88% for at least one function, with predictive applications gaining traction for enhanced supply chain resilience in manufacturing.^[62]

Advantages and Limitations

Benefits

Lot numbers significantly enhance operational efficiencies in supply chains by enabling faster product recalls and improving inventory management. In the event of a quality issue, lot tracking allows companies to isolate affected batches quickly, reducing the overall scope of recalls and thereby cutting direct costs. For instance, a study by the Food Marketing Institute and the Grocery Manufacturers Association indicates that a single recall can cost a company around $10 million in direct expenses, but effective lot systems mitigate this by limiting the recall to specific lots rather than entire product lines.^[63] Additionally, implementation of lot tracking as part of automated inventory systems has been shown to improve inventory accuracy by 25-35%, minimizing stock discrepancies and optimizing storage and distribution processes.^[64] From a safety perspective, lot numbers play a crucial role in minimizing health risks, particularly in pharmaceuticals and food sectors, by facilitating precise isolation of contaminated or defective products. This traceability reduces the spread of outbreaks; companies using automated lot traceability systems report up to a 50% reduction in foodborne illness incidents compared to those without such mechanisms.^[65] Research from the International Trade Centre further supports that traceability can shrink recall scopes by 50-95%, preventing broader exposure to hazards and protecting public health.^[66] Business advantages of lot numbers include bolstering supplier accountability and fostering consumer trust through transparent sourcing and rapid issue resolution. By linking products to specific suppliers and production runs, lot systems enable manufacturers to hold partners responsible for defects, streamlining accountability in the supply chain.^[67] This transparency also builds consumer confidence, as verifiable tracking demonstrates commitment to quality and safety, enhancing brand reputation.^[68] Studies indicate that traceability integration leads to 20-30% faster resolution of quality issues, allowing businesses to address problems proactively and maintain operational continuity.^[69]

Challenges

One significant barrier to effective lot number implementation is the high cost associated with adopting digital tracking systems, particularly for small and medium-sized enterprises (SMEs). Initial investments in software, hardware, and integration can be prohibitive, with estimates often intimidating smaller manufacturers who lack the resources of larger operations.^[70] For instance, a mid-sized pharmaceutical firm reported spending $175,000 on an advanced lot tracking solution, highlighting the financial strain even for those with some scale.^[71] Legacy system incompatibilities further exacerbate these challenges, as older equipment and software are frequently not designed for seamless data sharing with modern traceability tools. This often necessitates parallel record-keeping or costly middleware solutions to bridge gaps, leading to inefficiencies and delayed adoption.^[70]^[71] In manufacturing environments reliant on outdated infrastructure, such hurdles can perpetuate manual processes and hinder overall supply chain visibility. The absence of universal lot number formats poses another critical issue, resulting in inconsistencies that propagate errors throughout global supply chains. Companies employ diverse coding methodologies tailored to local regulations or operations, such as alphanumeric identifiers under FDA guidelines and GS1-compliant formats in the EU, which complicate cross-border tracking and increase the risk of misidentification during recalls or quality checks.^[1] Without standardized formats across industries and regions, interoperability suffers, leading to mismatched data in multinational operations and potential compliance failures.^[12] These variations across sectors, like pharmaceuticals versus food production, amplify the inconsistency, making unified error resolution more difficult. Privacy and security risks in lot number-based traceable systems have intensified, with data breaches exposing sensitive batch and distribution information. In 2023, supply chain security incidents rose 26% year-over-year, underscoring vulnerabilities in interconnected tracking networks that store lot data.^[72] Similarly, in the food sector, incidents like those affecting distributors in 2023 demonstrated how breaches in tracking platforms can lead to tampered lot records and widespread contamination risks.^[73] Human factors remain a persistent hurdle, with inadequate training contributing to errors in manual lot number assignment and labeling. Approximately 10% of human errors in manufacturing stem from insufficient training, often resulting in incorrect batch designations that undermine traceability.^[74] In fast-paced environments, factors like fatigue and oversight exacerbate these issues, leading to mislabeling rates where over 10% of goods may be incorrectly tagged annually, according to industry surveys.^[75] Addressing these requires ongoing education, yet resource constraints in smaller operations often leave staff ill-equipped for precise manual processes.

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Jul 13, 2021 · Takata, an auto supplier, was forced to recall nearly 67 million airbags after a spate of deadly accidents. The firm's airbags were found to be ...
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TAKATA AIRBAG RECALL – Could Cloud MRP, ERP and Lot ...
Apr 27, 2017 · Lot and Serial number controlled items are consumed in the manufacturing process and a full level traceability tree is constructed and ...Missing: parts | Show results with:parts
[31]
How to Fulfill AS 9100 Traceability Requirements as a Defense ...
Oct 31, 2016 · Companies must maintain extraordinary levels of traceability, including the serial and lot numbers for every component in an assembly.
[32]
Traceability in Aerospace Manufacturing
Here at Intrex Aerospace, we are experienced at maintaining lot and material traceability as part of our extensive quality control programs. Our company can ...
[33]
Batch Traceability in Aerospace - ConRo
Jul 7, 2025 · With effective batch traceability, manufacturers can pinpoint the exact origin of materials, supporting root‑cause analysis when issues arise.
[34]
Lot numbers : key to supply chain & quality control - Qoblex
May 14, 2025 · Historical lot data analysis ... Defect clustering by lot number identifies 89% of production issues within two manufacturing cycles.
[35]
Lot Traceability in the Apparel and Textile Industry - Blue Link ERP
In the apparel and textile industry, lot numbers are allocated in order to track dye lots with the focus on tracking colors (and not expiration dates). A ...
[36]
Traceability in Textile and Clothing Supply Chains: Classifying ...
Mar 21, 2019 · The purpose of this study is twofold. First, to explore and classify factors influencing traceability implementation, and second, to cluster essential ...
[37]
AMMUNITION - British Artillery in World War 2
Single letter code markings were marked on packaging, cartridge case and charge bags together with the manufacturing Lot number. These were used to sort ...
[38]
Artillery Shell Markings | PDF - Scribd
Lot Number The lot number is very important in accounting control and in malfunction investigations. The lot number of ammunition is on the lower right-hand ...
[39]
[PDF] Applying GS1 Standards for Supply Chain Visibility in Blockchain
Jan 30, 2020 · Global Trade Item Number + Lot/Batch number (LGTIN). The combination of a GTIN plus batch/lot number. 2.5. Serial Shipping Container Code (SSCC).
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Drug Supply Chain Security Act (DSCSA) - FDA
Oct 16, 2025 · The Drug Supply Chain Security Act (DSCSA) outlines steps to achieve an interoperable and electronic way to identify and trace certain prescription drugs.DSCSA Policies · FDA's implementation of... · Title II of the Drug Quality and...
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Regulation - 178/2002 - EN - EUR-Lex - European Union
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law.Missing: lot 1169/2011
[42]
Good Manufacturing Practice for Drugs (2010 Revision)
Jul 25, 2019 · Article 96: Water for pharmaceutical use should be suitable for its intended use, and meet the specifications of the Chinese Pharmacopeia and ...
[43]
Food and Drug Regulations ( CRC , c. 870) - Laws.justice.gc.ca
Jun 4, 2025 · 003(b) and importer of a drug in dosage form shall retain in Canada a sample of each lot or batch of the packaged/labelled drug for one year ...
[44]
21 U.S. Code § 333 - Penalties - Law.Cornell.Edu
Any person who violates a provision of section 331 of this title shall be imprisoned for not more than one year or fined not more than $1,000, or both.
[45]
[PDF] Special report 23/2024: Food labelling in the EU
We checked the EU legal framework and how consumer understanding of labels is monitored. We also looked at member states' control systems, how they check that.
[46]
Provisions for Drug Insert Sheets and Labels
Jul 25, 2019 · Article 20 The label for drug substance shall include the adopted name in China, storage, production date, batch number, expiry date, applied ...Missing: lot retention period
[47]
Amended Drug Administration Law of China - DIA Global Forum
The Amended Law abolishes the certification requirements of good clinical practice (GCP), good supply practice (GSP), and good manufacturing practice (GMP); as ...Missing: lot | Show results with:lot
[48]
How can lot numbers be generated during production?
There are two ways to do this, Automatic (called Auto Lots) and Manual (manual input of lot numbers by workers). Automatic lot generation. To access those ...
[49]
Creating Batch Numbers - SAP Help Portal
You can create batch numbers for finished goods as well as for co-products and by-products of an order.
[50]
Q7A Good Manufacturing Practice Guidance for Active ... - FDA
Batch Number (or Lot Number): A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and from which the production and ...
[51]
Serial Number Generation and Assignment - Oracle Help Center
Lot Number: During material transactions, you first specify the lot number and then the serial number. Inventory tracks the lot from which a specific serialized ...
[52]
What's in a Lot Number and Why It Matters - ERP Software Blog
Aug 26, 2025 · A lot number is a unique identifier assigned to a group or “lot” of items that were produced under the same conditions. Think of it as a digital ...Missing: 2020s | Show results with:2020s
[53]
Critical Role of RFID in America's Supply Chain
Sep 18, 2024 · Batch and Lot Tracking: RFID tags on crates, pallets, or individual items can store information about batch numbers, production dates, and ...
[54]
Enhancing Supply Chain Traceability through Blockchain and IoT ...
Feb 6, 2024 · This comprehensive literature review examines how the integration of blockchain and the Internet of Things can enhance supply chain traceability.
[55]
Convergence of Blockchain, IoT, and AI for Enhanced Traceability ...
Jan 10, 2025 · This paper presents a bibliometric and systematic literature review (SLR) to examine trends, research patterns, and methodologies in integrating BC IoT and AI ...
[56]
Blockchain technology in supply chain management: Innovations ...
This paper reviews the literature on blockchain technology and applications in core industries such as transportation, manufacturing, food and beverages, and ...
[57]
(PDF) ERP SYSTEMS AND WAREHOUSE MANAGEMENT BY WMS
This article presents differences between Enterprise Resource Planning Systems and Warehouse Management Systems.
[58]
Recalls, Corrections and Removals (Devices) - FDA
Identify clearly the product, size, lot number(s), code(s) or serial number(s) and any other pertinent descriptive information to enable accurate and immediate ...Missing: reputable | Show results with:reputable
[59]
[PDF] AI Driven Resilience Framework for US Manufacturing Supply Chain ...
Sep 3, 2025 · By ensuring real time, end to end traceability, digital threads provide supply chains with dynamic visibility and adaptability (National.<|control11|><|separator|>
[60]
The state of AI in 2025: Agents, innovation, and transformation
### Key Statistics on AI Adoption in Manufacturing and Supply Chain for 2025
[61]
Lot Tracking: How to Boost Traceability in Manufacturing
Benefits of lot tracking · Improve product quality · Help identify manufacturing defects · Assist in root cause analysis · Improve customer satisfaction · Reduce the ...
[62]
Automated Inventory Management Systems with IoT Integration to ...
Nov 1, 2024 · Studies reported average inventory accuracy improvements of 25-35%, reduction in carrying costs [1] by 20-30%, and decrease in stockout ...
[63]
Top 5 Benefits of Food Traceability Software for Manufacturers
Feb 12, 2025 · Companies leveraging automated traceability systems have reported a 50% reduction in foodborne illness outbreaks, proving the effectiveness of ...
[64]
Traceability In The Food Industry: Benefits & Implementation
Aug 11, 2025 · A traceability code is a unique identifier assigned to a batch or lot of food products. It helps businesses track production details, processing ...
[65]
Why Supply Chain Traceability Matters - Epicor
Dec 2, 2024 · Supply chain traceability ensures businesses can track products from raw materials to final delivery, helping manage risks, improve efficiency, and meet ...2. Customer Trust And Brand... · 3. Increased Efficiency And... · 4. Regulatory Compliance And...
[66]
What is Traceability and How to Achieve It? - MRPeasy
Rating 4.6 (215) Jun 26, 2023 · Traceability enhances credibility and trustworthiness in the market, leading to increased customer confidence and a positive perception of the ...
[67]
Implementation Guide: Complete Pharmaceutical Traceability - Zelthy
Jul 28, 2025 · 20-30% faster regulatory reporting and compliance activities ... Problem: Inconsistent data formats, incomplete information, and quality issues ...
[68]
Traceability in Manufacturing – A Comprehensive Guide for SMEs
Rating 4.6 (215) May 12, 2025 · Learn how traceability protects your production process and discover practical ways to implement it without blowing your budget.
[69]
The Role of Lot Meaning in Products: Batch Tracking and Inventory ...
Aug 28, 2025 · Batch tracking through lot numbers provides unprecedented visibility into product movement and history. This tracking mechanism enables ...
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Supply Chain Security Breaches Increased in 2023
Dec 14, 2023 · The mean number of supply chain breaches increased from 3.29 incidents in 2022 to 4.16 incidents in 2023, a 26% rise.Missing: examples lot
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[PDF] Analyzing the Sunpharma Ransomware Attack - Infonomics Society
This research project delves into cyber security in the pharmaceutical industry, focusing on a significant incident involving Sun Pharmaceutical.
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Cybersecurity in the Food Sector: How Cyberattacks Can Disrupt the ...
Jul 12, 2024 · Cybersecurity in the food supply chain has become a major concern amid increasing attacks on companies like Dole, Mondelez, and Sysco.
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Human Error: A Persistent Challenge in Manufacturing Operations!
It's well-known that improper training can lead to human error. In fact, statistics show that 10% of human errors are caused by inadequate training.
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The numbers on mislabeling. How does your organization compare?
Jul 22, 2021 · 76% of respondents said that more than 10% of their organization's goods are labeled incorrectly every year, while more than a quarter in total (26%) say more ...Missing: lot 2023