February 2024 - rfxcel.com

Indonesia Track and Trace Regulations: What They Mean for the Pharma Industry

Posted on February 13, 2024 by rfxadmin

Indonesia track and trace regulations are designed to prevent counterfeit, stolen, contaminated, or otherwise harmful drugs from entering the supply chain. The goal is to protect consumers and increase patient safety, as well as boost Indonesia’s competitiveness in the pharma global pharma industry.

The National Agency of Drug and Food Control (BPOM) began rolling out regulations in 2018. In 2022, it established provisions and procedures for implementing 2D DataMatrix codes for drug and food products. The country’s digital platform is called the Track and Trace Anti-Counterfeit (TTAC) system.

Key regulations went into effect in 2023; the next big deadlines are set for 2025 and 2027. So let’s take a closer look at Indonesia track and trace regulations and what they mean for the pharma industry.

Indonesia’s Pharma Market in Context

At the time of writing, Indonesia’s population is approaching 279 million — the fourth largest in the world. It’s no surprise, then, that the sprawling archipelago is the largest pharmaceutical market in Southeast Asia.

According to Business Indonesia, sales of medicines in 2020 were valued at about $7.6 billion (110.6 trillion rupiah); this is expected to increase to more than $11 billion (176 trillion rupiah) by 2025. In terms of U.S. dollars, this equates to a compound annual growth rate of 10.7 percent.

Furthermore, the Indonesian government is making significant investments in the country’s healthcare system. The same Business Indonesia article reported that healthcare spending in 2022 accounted for 9.4 percent of the total government budget.

In this context, Indonesia is seeking to expand and open its pharmaceutical sector to foreign participation and investment. Pharma companies that already have an in-country presence or that want to enter the market must fully understand — and comply with — Indonesia track and trace regulations.

The Framework of Indonesia Track and Trace Regulations

Most of today’s global pharma compliance requirements have a few things in common:

- - Companies must register products with a country’s regulatory body.
  - Companies must send compliance information to a centralized system (e.g., a portal or website like Indonesia’s TTAC).
  - Products must be labeled in a manner that identifies them at the unit level (i.e., serialization) and/or a “higher” level, such as a pallet or case (i.e., aggregation).
  - Regulators prefer GS1 labeling standards [e.g., 2D DataMatrix codes, Global Trade Item Numbers (GTINs), and Serial Shipping Container Codes (SSCCs)]. Read our “Understanding GS1 Barcodes in the Global Supply Chain” article for a comprehensive overview of these standards.

Indonesia track and trace regulations follow this basic framework:

Registration

Imported and locally produced medicines must be registered with the BPOM before they can be distributed. Pharma companies must have a local business agent or partner to register products, and it’s advisable to obtain all permissions before exporting products to Indonesia.

Labeling

The BPOM requires all medicines sold in Indonesia to be labeled for identification, and upcoming regulations will further require products to be labeled for authentication. The BPOM uses GS1 standards.

Identification Barcodes

Starting on December 7, 2023, traditional medicines and over-the-counter drugs — as well as cosmetics, supplements, processed foods, and some raw materials — were required to be labeled with a QR code that identifies the product in the market and verifies that it’s legal. For products that do not have to be serialized, this is the only marking required.

Identification codes must contain a Marketing Authorization Number and an NIE, or Nomor Izin Edar, which can be translated as “distribution permit number,” both issued by the BPOM. Alphanumeric NIEs provide master product data, including where the product was manufactured, and allow verification through a database called Cek Produk BPOM (“Check BPOM Products,” roughly).

Authentication Barcodes

December 7, 2025, is the deadline for serializing and labeling narcotics and psychotropics (e.g., antipsychotics and antidepressants) with a 2D DataMatrix code. By December 7, 2027, all prescription drugs, including biological products, must be serialized and authenticated. Aggregation, following GS1 standards, is also required.

The authentication codes must contain the following information:

- - A GS1 Global Trade Item Number (GTIN)
  - A Marketing Authorization Number from the BPOM
  - A production code or batch number
  - An expiration date
  - A serial number

Companies can obtain codes from the BPOM or from an independent source.

Some products/packs are exempt from the authentication requirement. These include blister packs, strip packs, pre-filled syringes, stick packs, single packaging, and catch covers.

Other Indonesia Track and Trace Regulations: Distribution

The BPOM has other requirements coming into effect between 2024 and 2026:

- - December 7, 2024: Distribution centers with minimum stock keeping units (SKUs) of 1,500 serialized products must submit reports to the BPOM.
  - December 7, 2025: “Second-tier” distribution centers (min. 750 serialized products) must submit reports to BPOM. Note that this coincides with the deadline for serializing and labeling narcotics and psychotropics.
  - December 7, 2026: “Third-tier” distribution centers (min. 400 serialized products) must submit reports to BPOM. This applies to certain categories of pharmacies or clinics.

Electronic Leaflet Pilot (2023-2025)

A pilot for electronic leaflets (e-leaflets) began in July 2023 and is scheduled to conclude in July 2025. Wanting to transition from a paper-based system, the BPOM plans to develop a dedicated mobile app for scanning a single code (likely the mandated GS1 2D DataMatrix code) that will take users to information online. The pilot is being conducted in three phases:

- - Phase I for vaccines and injections (completed)
  - Phase II for prescription drugs, including vaccines and injections (completed)
  - Phase III for over-the-counter and prescription drugs, including vaccines and injections (in progress)

Final Thoughts About Indonesia Track and Trace Regulations

As we said above, Indonesia is seeking to expand and open its pharmaceutical sector to foreign participation and investment. Pharma companies that already have an in-country presence or that want to enter the market must fully understand — and comply with — Indonesia track and trace regulations.

This is where we can help. Our solutions for global pharma compliance will help ensure you’re prepared for Indonesia’s requirements for product identification, serialization, and aggregation.

It’s all part of our 20-year commitment to protecting patients, combatting counterfeit drugs, and securing supply chains. Our solutions report into all global government agencies, help ensure you meet your regulatory obligations, and protect products and people everywhere you do business. Contact us today to learn how it works!

FSMA Produce Safety Rule: Cultivating Compliance in Agriculture

Posted on February 13, 2024February 14, 2024 by rfxadmin

The Food Safety and Modernization Act (FSMA) is going to have a major impact on the food industry. FSMA gives the Food and Drug Administration (FDA) enforcement capabilities to promote food safety, transparency, and quality, and the FSMA Produce Safety Rule is particularly important to the changes.

The FSMA Produce Safety Rule applies to commercial growers, harvesters, and packers of produce. The rule includes preventive controls designed to mitigate the spread of pathogens and foodborne illness through agricultural water, wild animals, and any raw agricultural commodity designed for human consumption. Here’s what you need to know.

Importance and Business Value of the FSMA Produce Safety Rule

In effect since January 26, 2016, the FSMA Produce Safety Rule (“Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”) is a major step forward for agricultural traceability, food safety, and public health. As the FDA explains, it “establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The rule is part of the Agency’s ongoing efforts to implement the FDA Food Safety Modernization Act.”

Familiarizing yourself with the FSMA Produce Safety Rule will help comply USDA and FDA regulations, avoid fines or other regulatory penalties, and promote business continuity. From a value-addition perspective, compliance means you’ll safeguard your products, appeal to consumer demands for transparency and accountability, and protect your brand reputation.

Key Components of the FSMA Produce Safety Rule

The FSMA Produce Safety Rule is built around Good Agricultural Practices. Those practices address the following areas:

Agricultural Water

Water, essential in agriculture, can be a major source of contamination. Both production and post-harvest water require careful management, which may include:

- - Regular testing and monitoring of surface and ground water for pathogens
  - Water treatment to meet safety standards
  - Maintenance and inspection of water sources

Strictly monitoring and protecting water is vital for ensuring compliance with the FSMA Produce Safety Rule.

Employee Health and Hygiene

Employee health and hygiene are paramount when dealing with produce for human consumption. When workers are sick or lacking training, they’re more likely to become (unintentional) sources of contamination.

Examples of health and hygiene requirements include instructing employees to notify their supervisors if they may have a health condition that may result in contamination of covered produce or food contact surfaces, using hygienic practices when handling such produce or surfaces (e.g., washing and drying hands, and taking measures to prevent visitors from contaminating produce and surfaces).

Domesticated and Wild Animals

Grazing animals (e.g., livestock), animals used for work applications, and wild animals (e.g., deer and feral swine), can compromise produce safety. The FSMA Produce Safety Rule requires farmers “to take all measures reasonably necessary to identify and not harvest produce that is likely to be contaminated.”

These measures include visually examining the growing area and all covered produce to be harvested and, in some circumstances, conducting an additional assessment during the growing season and taking reasonable steps to assist during harvest if significant evidence of potential contamination by animals is found, such as placing flags outlining an affected area.

Biological Soil Amendments

Biological soil amendments of animal origin (BSAAO) are soil amendments that contain materials of animal origin. These materials may include raw manure or non-fecal byproducts such as table waste, animal carcasses, or any combination thereof.

Though biological soil additives can enhance the quality and nutrient profile of soil, they also carry some risks. Therefore, make sure that any additives are properly treated to reduce pathogens.

Production of Sprouts

Sprouts are particularly vulnerable to contamination by dangerous microbes due to the warm, moist, and nutrient-rich conditions needed to grow them. The FSMA Produce Safety Rule has requirements to help prevent the contamination of sprouts, such as:

- - Taking measures to prevent the introduction of dangerous microbes into or onto seeds or beans used for sprouting
  - Treating seeds or beans that will be used for sprouting (or relying on prior treatment by the seed/bean grower, distributor, or supplier with appropriate documentation)
  - Testing irrigation water for certain pathogens and attaining negative results
  - Testing the growing, harvesting, packing, and holding environment for the Listeria species or Listeria monocytogenes
  - Taking corrective actions if spent sprout irrigation water, sprouts, and/or an environmental sample tests positive

Equipment, Buildings, Tools, and Sanitation

The condition and cleanliness of your farm’s infrastructure — greenhouses, germination chambers, and toilet and hand-washing facilities — play a crucial role in compliance and safety. The FSMA Produce Safety Rule establishes standards related to equipment, tools, and buildings to prevent them from contaminating produce, including from inadequate sanitation.

Therefore, you should establish a routine for cleaning and sanitizing tools, equipment, and buildings. Regularly inspect and maintain equipment to prevent it from becoming a contamination source. Where possible, design facilities and equipment to be easily cleaned and to prevent harborage of pests and accumulation of dirt.

Compliance Guidelines for Farmers

The FDA provides resources explaining FSMA requirements, including the Produce Safety Rule. Let’s look at some practical tips for promoting and simplifying compliance.

One major hurdle is creating an actual compliance policy. If you run a farm, you need a comprehensive policy that addresses all facets of the Rule. This fact sheet from USDA is a helpful tool for designing and implementing your policy. If you operate a large farm, read the FDA’s “What to Expect Now That Larger Farms Must Comply with the FSMA Produce Safety Rule” here. Also check out the Sprout Safety Alliance at the Illinois Institute of Technology and the Produce Safety Alliance at Cornell University’s College of Agriculture and Life Sciences, for example.

Once you know which rules apply to your farm, develop a plan to address each relevant area. Remember, incremental improvements to enhance safety is a place to start; you don’t have to revamp your entire operation overnight.

Recordkeeping and Documentation

FSMA 204 establishes additional traceability recordkeeping requirements for companies that manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). If the Produce Safety Rule applies to your business, you should also familiarize yourself with The Final Rule on Requirements for Additional Traceability Records for Certain Foods — also known as the “Food Traceability Final Rule.”

FSMA 204 requires you to maintain (keep) and share accurate records of your products as they move through the supply chain. If you get audited, you’ll have to produce these records. Download our food traceability white paper to learn more about these requirements.

Water Quality and Agricultural Practices

The water quality provision (and most other provisions) of the FSMA Produce Safety Rule went into effect in 2018. Since then, the FDA has been ramping up enforcement actions. They have paid particularly close attention to water quality. Under the rule, you have to test the untreated groundwater for generic E. coli. If you use water that has been treated with a validated process or from a public source, testing is not required. Additionally, you are prohibited from using any untreated surface water for harvest or post-harvest purposes.

Soil Amendments

The FSMA Produce Safety Rule includes other provisions regarding soil usage — specifically, the introduction of animal byproducts into your soil. If using raw manure or any other animal byproducts to enhance soil productivity, you must take precautions to mitigate the risk of contamination. Be careful when sourcing manure and other animal-based soil enhancements, and always verify that the provider is compliant with FSMA provisions.

Final Thoughts: Being Proactive Simplifies FSMA Compliance

The FSMA Produce Safety Rule is being enforced now, and the deadline to comply with FSMA 204 traceability requirements is January 20, 2026. As we’ve said all along, the key to FSMA success is to be proactive. Specifically:

- - Study the law and know your obligations and your trading partners’ obligations.
  - Talk with your trading partners to ensure they’re compliant now and preparing for January 2026.
  - Assess your operations for compliance with the FSMA Produce Safety Rule and Food Traceability Final Rule.
  - Make sure you’re working with a knowledgeable and reliable solution provider — someone who can help you comply while keeping your supply chain moving at peak performance and leveraging the FSMA regulations to create business opportunities.

This is where we can help. We offer a full-stack solution for the food industry. We can answer your questions, show you in concrete detail how we create end-to-end traceability in supply chains, and discuss how to use traceability to safeguard your brand and protect your bottom line. Contact us today to talk with us and schedule a demo.

And read this if you’re interested in learning about how rfxcel technology helped a major berry producer control the safety and quality of more than 1.5 billion products.

Foreign Supplier Verification Program (FSVP): What It Means for FSMA

Posted on February 12, 2024February 14, 2024 by rfxadmin

The Food and Drug Administration Food Safety and Modernization Act (FSMA) is going to change how the U.S. food supply chain works. And not just for U.S. companies. When the law takes effect in January 2026, foreign companies that import food to the United States must also comply. This is what the FSMA Foreign Supplier Verification Program (FSVP) is all about.

If you’re an importer, you’re subject to the FSVP under FSMA. If you’re a U.S.-based company, you want to make sure your non-U.S. trading partners are compliant.

Here is everything you need to know about the FSVP so that you can achieve and maintain FSMA compliance.

What Is an Foreign Supplier Verification Program? What Is the Significance?

Technically, FSVP stands for Food Supplier Verification Programs (plural). An FSVP is a program that promotes traceability, food safety, and transparency across the entire food supply chain. It mandates that importers perform certain activities to facilitate public health protection and verify that imported food meets the FSMA safety requirements.

Under a Foreign Supplier Verification Program, importers are required to verify that the food they import meets U.S. safety standards. They must develop, maintain, and follow an FSVP for each food imported, unless an exemption applies. The goal, therefore, is to ensure that every imported food has been produced in a way that delivers the same level of public health protection as the applicable FSMA requirements, and that food is not adulterated or misbranded with respect to allergen labeling.

Why is the Foreign Supplier Verification Program necessary? The answer is simple: The United States imports billions in food each year. According to the USDA, the U.S. imported $148 billion in agricultural products in 2020. U.S. food also includes a huge amount of imported animal products.

By extending FSMA requirements to importers and their suppliers, the Foreign Supplier Verification Programs promote increased safety and accountability. It also provides insights into each foreign supplier’s performance, enabling U.S. food businesses to make informed decisions about their trade relationships and promote good manufacturing practices.

Who Is Covered by the FSVP?

It defines an importer as “the U.S. owner or consignee of the food offered for import (i.e., owns the food, has purchased it, or has agreed in writing to purchase it at the time of U.S. entry).” If there isn’t a U.S. owner or consignee at time the product enters the USA, the FSVP defines the importer as “the U.S. agent/representative of the foreign owner/consignee, as confirmed in a signed statement of consent.”

The important takeaway is that there must be a U.S.-based FSVP importer who takes responsibility for meeting the FSVP requirements.

Key Components of the FSVP

The Foreign Supplier Verification Program is built on widely accepted food safety standards and preventive controls rules. Key FSVP requirements include the following:

- - Hazard analysis: Importers must analyze hazards associated with each food.
  - Supplier verification: The FSVP outlines appropriate supplier verification activities that importers must complete.
  - Corrective actions: Procedures must be in place to address identified issues.

Requirements for Importers

An FSVP importer may need to perform the following activities, unless they’re exempt or subject to modified requirements.

Verify Suppliers

Conduct appropriate supplier verification to assure that the hazards requiring a control in the food you import have been significantly minimized or prevented. These activities may include annual onsite audits by a qualified auditor, sampling and testing food, and reviewing the supplier’s food safety records.

Perform a Hazard Analysis

Hazard analyses must include identifying “known or reasonably foreseeable hazards” and determining if they require a control. The FDA notes several types of hazards, including the following:

- - Biological (e.g., parasites and disease-causing bacteria)
  - Chemical (e.g., radiological hazards, pesticide and drug residues, natural toxins, unapproved additives, food allergens, and nutrient deficiencies or toxicities in animal food)
  - Physical (e.g., objects in food products such as glass)

Evaluate Risks

You must evaluate risks that the food itself and the foreign supplier’s performance could pose. In doing so, you must consider the following:

- - Your hazard analysis for the food
  - Who will apply the hazard controls (e.g., the supplier or its ingredient supplier)
  - The supplier’s food safety practices and procedures
  - Applicable U.S. food safety regulations and information about the supplier’s compliance
  - The supplier’s food safety performance history, which should include testing and audit results and the supplier’s record of correcting identified problems.

Perform Periodic Reassessments

You have to reassess your foreign suppliers every three years — or sooner if the FSVP importer becomes aware of new information about hazards in the food or changes in the foreign supplier’s performance.

Identify the FSVP Importer

As an FSVP importer, you are required to provide the U.S. government with the following information about your organization:

- - Legal business name
  - Electronic mailing address
  - Unique facility identifier (UFI)

The FDA accepts the Data Universal Numbering System (DUNS) number as a UFI. FSVP importers temporarily unable to obtain a DUNS number have since May 2017 been permitted to transmit the value “UNK” (i.e., “unknown”) in the UFI field, allowing food to be processed through the Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system, even if the importer has not yet provided a DUNS number.

Other Requirements

You must use a qualified person to develop an FSVP and to perform FSVP activities.

Furthermore, you must take corrective actions (if necessary) and investigate the adequacy of the FSVP (when appropriate). The corrective action will depend on the circumstances; for example, the best course of action may be to stop using the foreign supplier until the problem (e.g., noncompliance, adulteration, misbranding) has been adequately addressed.

Last, you’re required to maintain detailed FSVP records. A U.S. agent can request these records during an audit. Alternatively, they might review them during a randomized compliance assessment. Make sure you retain all digital records related to your FSVP compliance activities for at least two years.

Role of Technology in FSVP Compliance

Old-school compliance strategies can’t keep pace with the stringent recordkeeping and analytics mandates found in the Foreign Supplier Verification Program framework. Instead, you need a robust suite of technologies designed to accelerate and simplify compliance.

Adopting food supply chain software will empower your team to gather and manage key details about trading partners. With the right tools in place, you can transform food safety and regulatory compliance into an integrated part of your company culture.

Collaboration with Foreign Suppliers

FSVP compliance is a joint effort; you cannot achieve and maintain compliance without the support of your foreign suppliers. Reputable and successful foreign suppliers will embrace FSVP, as they understand that they cannot import their goods to the United States without complying.

Use this to your advantage. Reach out to your trading partners, relay what requirements apply to your organization and its operations, and develop a cohesive strategy to meet FSVP provisions. Building strong relationships with suppliers is key to a successful verification and hazard mitigation program.

FSVP Rollout and Influence

To date, compliance with the Foreign Supplier Verification Programs has been a challenge for many importers. According to a 2020 FDA report, in 2019 the Agency issued 340 citations to companies for failing to develop an FSVP — a 17 percent increase over 2018. In total, there were 354 non-compliance citations, including for failing to:

- - Follow or maintain the FSVP
  - Translate the FSVP into English when applicable
  - Sign and date the FSVP upon modification
  - Make adequate assurances of a supplier’s food safety

Over the last two years, the FDA has ramped up enforcement, which means that preparedness and diligence are more important than ever. As the Agency itself says, “Being prepared is key to avoiding a citation.”

Even with these challenges, the food industry should anticipate that FSVP will have a broader, sustained impact on global food supply chains. Along with FSMA, it encourages international suppliers to elevate their food safety standards, adopt best practices, and embrace food safety in a digital, traceable supply chain. This will lead to a more uniform global food safety system, enhancing consumer confidence in the safety of foods everywhere.

It’s likely that more and more countries will enact or continue rolling out similar food safety regulations on imported goods. When they do, it will accelerate the push toward safer, more sustainable food production practices.

Final Thoughts: Achieve Foreign Supplier Verification Program Compliance

As we’ve seen, the FSVP requires a lot of importers and their foreign suppliers, and many organizations have struggled with compliance.

The keys to success (and avoiding citations and fines) are preparedness and proactive implementation of FSVP practices and technologies that will yield a safer and more transparent food importation process.

If you don’t know where to start, contact us today to book a demo. Our traceability and transparency solutions for the food and beverage industries not only take the guesswork out of compliance — they transform all your supply chain data into true business value.