This phase of data collection and situation assessment will enable us to develop a roadmap, focus on the right areas, and prioritize the actions with the greatest impact.

This article introduces the principles for mapping waste at one or more pharmaceutical manufacturing sites. These principles are detailed in the Technical Paper prepared by the authors of this article.

1. The Regulatory Framework

Regulations governing the management of pharmaceutical waste are based on a set of international and national laws and regulations designed to ensure public health and environmental protection.

These texts include, for example:

• Internationally recognized agreements such as the Basel Convention 
• European-level legislation such as Directive 2008/98/EC and Decision 2014/955/EU
• National laws such as the Environmental Code (Article L541-1) in France
• ISO standards such as ISO 14001 and ISO 24161

2. Waste treatment streams

2.1. The waste management hierarchy

Waste management streams are typically classified into six levels, ranging from the “most environmentally sound” (source reduction) to the “least environmentally sound” (landfilling), following the logic illustrated in Figure 1, based on the definitions set forth in European Directive 2008/98/EC and ISO Standard 24161.

When collecting data for a production facility, it is important to gather information regarding the management of various types of waste. 

Based on this assessment, action plans can be developed and implemented to move toward more sustainable treatment methods. (Figure 1)

2.2. Classification of waste treatment streams

In an effort to standardize waste treatment and recovery methods, recovery and disposal codes have been established internationally under the Basel Convention. Among these codes, there are 13 operations under code R (R1 through R13) corresponding to codes dedicated to waste recovery, and 15 operations under code D (D1 through D15) corresponding to waste disposal according to various parameters.

The following codes are the most commonly used in the pharmaceutical industry 

The various waste treatment processes are summarized in Figure 2.

3. The data collection method

3.1 The objectives of waste mapping

To implement more “sustainable” waste management, the first step is to map the company’s various waste sources. Mapping involves cataloging, identifying, and locating the different types of waste generated at industrial, logistics, and commercial sites.

Various key factors are critical to this process.

3.2 Methodology for Waste Mapping

Establishing a methodology for waste mapping enables a consistent approach to be applied over time and allows for comparisons between a company’s various sites in the case of multi-site organizations. The proposed methodology consists of seven steps. (See Table 1 below)

Step 1: Set your goals

Define the purpose and scope of the mapping exercise and prioritize the data to be collected 

Step 2:  Structure the mapping project 

Establish project governance, the deployment plan, and the necessary resources

Step 3: Standardize the data to be collected

Develop a standardized data collection form that includes, for example: 

• Waste type (EER/CED code – European nomenclature)
• Quantity (kg, tons)
• Treatment method (reuse, recycling, recovery, disposal)

The waste registry serves as the basis for mapping, if applicable in the country. To facilitate data processing, it is recommended that the collection grid include groupings by waste category.

Step 4: Implement data collection and analysis tools

For example, use a shared digital tool (e.g., Power BI, a shared spreadsheet, etc.) that can be integrated with existing EHS, CSR, ESG, or ERP software.

Step 5: Engage local stakeholders (including external ones)

Train and educate local teams on waste identification and promote local waste reduction and sorting initiatives; collect reliable data by involving waste collection service providers.

Step 6: Analyze the data and develop action plans

Identify key waste streams and critical issues (hazardous waste, large volumes, high costs, poor traceability, etc.), use mapping as a starting point for corrective or optimization measures (reduction at the source, reuse, improved recovery, better sorting, etc.), and develop waste performance indicators (kg/product, €/ton, % recycled, etc.)

Step 7: Strengthen regulatory compliance and ensure traceability

Ensure that the mapping complies with applicable regulations (BSD, chronological register, etc.) and maintain a record of approved service providers, contracts, and treatment certificates.

3.3. Data Sources

Two key types of documents, found at most industrial sites to identify all generated waste—particularly hazardous waste—are particularly useful for developing a waste inventory.

3.3.1 Waste Tracking Form (WTF)

The WTF is a document that must be issued by the waste generator to ensure the regulatory traceability of each waste item.

This requirement applies to all hazardous waste and certain regulated non-hazardous waste (e.g., asbestos waste, contaminated soil, etc.). 

The BSD contains information such as:

• Identification of the waste generator.
• Type, EER/CED code, quantity of waste.
• Type of packaging, hazard level.

3.3.2 The Chronological Waste Record (or Annual Record)

The chronological waste log is a document that must be maintained by the waste generator to systematically track all waste generated, shipped, or received, in chronological order.

Registration is mandatory, at a minimum, for producers of hazardous waste and primarily includes information from the WTF.

3.4. Return of experience

A waste mapping tool

Ensuring that all waste leaving an industrial site is clearly identified and tracked is no easy task at the company level.

The approach must be thorough and take into account all waste generated on-site, not just production waste. For example, construction waste, office waste, cafeteria waste, etc should not be overlooked.

Key considerations are:

• Are you sure you’ve identified all your waste management service providers?
• Does the waste log accurately track all waste generated at the site?
• Are there any collection agencies that collect metals, electronic waste, used containers, etc., without including these items in the reported tonnage?

Furthermore, the share of recycling and waste recovery varies greatly from one industrial site to another. Are these differences really due to how our service providers process our waste, or is it simply that each industrial site interprets the terms “reduction,” “recovery,” and “disposal” differently?

Our “Environmental Performance – Waste”, Interest Group GIC, “Waste” subgroup, has sought to answer these questions.

Our aim here is to provide a standardized waste mapping tool that anyone can use, enabling companies to share waste data management and allowing for comparisons between different sites.

Table 2 can be sent to every industrial site as standard, regardless of its location.

The purpose of this table is to provide a summary of data related to waste management at an industrial site. It does not require manufacturers to collect any additional data. This is because sites are required to maintain an annual waste report, which already includes all the necessary information.

Thus, the table is populated primarily by transferring and consolidating existing data. 

It outlines the types of industrial waste generated at an industrial site, specifying for each waste stream:

• Waste Category: A classification system used for analysis purposes that is specific to each company.
• Waste designation: This refers to the name of the waste as listed in the reports. 
• EWC code: the waste code defined in the European Waste Catalogue.
• D/R Code: a code indicating the treatment or recovery method for the waste, as required by regulations.
• Type of waste: nature of the waste (hazardous – HW or non-hazardous – NHW).
• Annual quantity in tons: the annual amount of waste, in tons, reported in the balance sheets.

This data collection should allow to assess the current situation at each industrial site.

For example, we have used it on the entrances to our industrial sites, and in some cases, we have doubled the amount of waste historically recorded using this new survey method.

This approach undoubtedly provides a better understanding of our waste management processes. What gets measured can be improved!

4. Use and analysis of the collected data

The widespread implementation of a waste mapping system, as described above, allows for the consolidation of data by waste category and ensures a consistent approach across all relevant sites.

Performance indicators can then be developed, which not only measure progress but also identify areas in need of improvement. By providing accurate and actionable data, they facilitate informed decision-making and the implementation of effective strategies. 

Below are a few examples of key performance indicators that can be implemented at the workshop, site, or company level. They are based on the example of a pharmaceutical company with three sites located in France.

4.1. Waste volume indicators

The first quantitative indicators that can be derived from waste mapping relate to the total amount of waste for each site or, on an aggregate basis, for the entire group:

• Total weight of waste
• Total weight of non-hazardous and inert waste
• Total weight of hazardous waste

These indicators can be expressed in tons, as shown in Figure 3, or as relative quantities based on the quantities produced at the site or relative to revenue. 

4.2. Recycling and recovery rates 

These indicators measure the proportion of recycled waste relative to the total amount of waste generated. These rates are commonly included in corporate reporting. In the absence of a specific standard for calculation, there are often discrepancies between companies, particularly with regard to energy recovery. The current trend is to no longer consider energy recovery as a material recycling process, particularly to account for its impact on carbon emissions and air emissions.

For the sake of clarity, it is therefore important to distinguish between:

The recycling rate refers to the proportion of waste that undergoes material recovery, whether through reuse, regeneration, or recycling. It is calculated based on waste mapping, taking into account the quantities of waste classified under treatment codes R2 through R11.

The recovery rate also includes waste used to generate energy through incineration (code R1).

As shown in Table 3, the recycling and recovery rates at the three sites of the company in question vary significantly, due in part to the high proportion of thermal recovery at two of the sites.

Indicators can also be presented graphically, allowing for comparisons between sites (Figure 5). As with waste volume indicators, it may be useful to report recycling and recovery rates separately for non-hazardous/inert waste and hazardous waste (Figure 6).

4.3. The Paretos

Waste volumes and recovery rates are aggregate data that serve as useful macro-level indicators. However, they do not readily facilitate the development of effective action plans because they do not take into account the characterization of waste. 

An initial analysis of the waste mapping allows waste to be grouped by category and the 10 or 15 largest contributors for the company or site in question to be identified. Pareto charts thus help identify the key levers for reducing waste at each site.

It is possible to determine the Pareto chart for total waste, potentially distinguishing between non-hazardous and hazardous waste, as shown in Figure 7. To support the development of action plans focused on identifying more sustainable waste management pathways, the Pareto chart can be centered on non-recycled waste, as shown in Figure 8.

4.4. Weighted amount of waste

Weighting allows us to reflect the diversity of waste management streams, such as material recovery (including recycling), energy recovery, incineration, and landfilling. Since each stream has different environmental and economic impacts, weighting ensures that the performance indicator is more accurate and relevant, as it assigns greater weight to the least environmentally sound streams. An example of weighting is provided in Table 4.

When the information is available, it is advisable to include in the calculation the quantities resulting from reduction and/or upcycling (such as reuse), in order to be able to assess the benefits of these approaches compared to recycling, for example.

This indicator can be calculated in two ways:

• The amount of waste expressed in weighted tons = tons of waste per treatment stream multiplied by the weighting factor
• A ratio of weighted tons divided by total tonnage

Figure 9 illustrates this concept of weighted waste quantities for the three sites in the case study. 

Analyzing this data, particularly in conjunction with waste Pareto charts, makes it possible to identify and measure the impact of various waste reduction plans. 

For example:

• Reduction in total waste volume through measures such as waste reduction or reuse → overall decrease in waste quantities.
• Establishment of a recycling program for a specific type of waste → weighting factor reduced to 0.2 for the quantities in question.
• Transition from incineration without thermal recovery to thermal recovery → weighting factor reduced from 0.8 to 0.5 for the quantities in question.
• Transition from landfilling to incineration → weighting factor reduced from 1 to 0.8 for the quantities in question.

The various actions identified should be prioritized, for example using a matrix that takes into account the gains in terms of weighted tonnage, technical feasibility, and implementation costs. 

This makes it possible to develop a roadmap for reducing weighted weights as part of a multi-year action plan. Monitoring of waste management initiatives and KPIs should then be incorporated into the environmental performance governance framework of the site or company.

5. Conclusion

Waste management in the pharmaceutical industry cannot be limited to mere regulatory compliance. It is part of a comprehensive and strategic approach to environmental performance that, by meeting societal expectations, enhances the competitiveness and appeal of companies in the pharmaceutical sector.

Waste mapping is the essential first step: it provides a clear picture of waste streams, identifies opportunities to reduce waste or improve waste management, and ensures regulatory compliance.

While the initial focus should be on reducing waste generated at sites under the company’s direct control, the next step will be to expand the scope beyond the site to encompass the entire product lifecycle.

Mapping waste is not an end in itself, but rather the starting point for a necessary transition toward a circular economy that respects public health and the environment.

References

• 1. Basel Convention of March 22, 1989, on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal.
• 2. Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives.
• 3. Decision No. 2014/955/EU of December 18, 2014, amending Decision 2000/532/EC establishing the list of wastes pursuant to Directive 2008/98/EC of the European Parliament and of the Council.
• 4. Article, Annex IV – Order of January 31, 2008, concerning the registry and annual reporting of emissions and transfers of pollutants and waste.
• 5. Article L541-1 – Environmental Code (France).
• 6. ISO 14001 – Environmental management.
• 7. ISO 24161 – Waste management.

Glossary

• BSD – Waste Tracking Form
• CED – European Waste Catalogue
• CSRD – Corporate Sustainability Reporting Directive
• HW– Hazardous Waste
• WEEE – ( Waste Electrical and Electronic Equipment)
• NHW – (Non-Hazardous Waste )
• KPI (Key Performance Indicator)
• EPR – Extended Producer Responsibility