Michael Sassano & Antonio Guedelha: GMP # 16 – Waste Reduction Management in Good Manufacturing Practice

Authored By: Michael Sassano & Antonio Guedelha 
     

Michael Sassano

Founder, Chairman & CEO Somai Pharmaceuticals -Investor, Cannabis, GMP, Pharmaceutical &Herbal Medicine https://www.linkedin.com/in/michaelsassano3/  

Antonio Guedelha

  The pharmaceutical manufacturing industry is one of the largest waste producers in the world. In the past, manufacturers paid a third-party removal company to dispose of waste. In recent years, the strict regulations enacted on manufacturers have prompted many companies to seek more sustainable production processes. The world of pharmaceutical waste management is developing more robust standards and dedicated groups to concentrate on sustainability, and individual companies must keep up.

Areas of Improvement for GMP-Certified Pharmaceutical Manufacturing Companies

Several standard practices in pharmaceutical facilities produce a significant amount of waste. We can start by addressing these issues to make the most effective immediate difference: 
  • Warehouses need to responsibly dispose of packaging materials used on pallets of raw materials. 
  • Manufacturing produces waste through single-use sampling tools, gloves, weighing containers and more. The product that sticks to the inside walls of the equipment can even be considered waste.
  • Packaging processes often waste paper, plastic, and other materials.
  • Quality control (QC) laboratories use solvents and other single-use materials, eventually becoming solid and liquid waste.

The Costs of Manufacturing Waste for European Pharmaceutical Manufacturing Companies

Considering the costs of manufacturing waste is an effective way to address the issue’s urgency. Waste treatment only can be performed by approved waste management companies, and different types of waste require disparate disposal methods. These companies are strictly regulated and must comply with environmental and safety regulations. The price of disposing of waste adds up very quickly. Tablets and injectables are the most common classes of pharmaceutical dosages. Yearly, these classes have a wastage rate of 20.78% to 16.49%. In comparison, the overall pharmaceutical wastage rate is approximately 3.68% across all medication classes. In the European Union (EU), prices for waste treatment of raw materials can range from 50 euros per ton to 200 euros per ton, depending on the type of waste. All prices for waste management are expected to increase over the coming decades. Waste is an increasingly important factor in the pharmaceutical world.

3 Approaches to Waste Management

Most pharmaceutical manufacturing companies in the EU want to decrease the quantity of waste they produce. Manufacturers can achieve this with changes to some of the materials and processes. However, high regulatory burdens on the pharmaceutical industry introduce some difficulties in finding a solution that fits the Good Manufacturing Practice (GMP) requirements. There are several different approaches to the problem of waste management in the pharmaceutical manufacturing industry. Reducing waste before it starts, recycling the inevitable waste, and taking a zero-waste approach are all viable options for different organizations.   

1. Reduce Waste and Curtail Single-Use

Reducing waste at an immediate level has both benefits and drawbacks. For example, replacing single-use plastics with reusable tools will reduce waste but increase cleaning protocols’ workloads. This requires changing the cleaning process so as not to leave small quantities of pharmaceutical chemicals on the surface or inner spaces of difficult-to-access containers. Facilities can also decrease waste through technological improvement. In manufacturing, these technological improvements focus on cleaning dead corners or other inaccessible spots, ensuring cleaner product-touching surfaces. Packaging machines are also improving, producing less waste in the packaging process.  Additionally, good stock management of raw materials will decrease waste due to expired materials. We previously visited this crucial topic in GMP #11: Stock Management in GMP Manufacturing.  

2. Step Up Waste Recycling Efforts

Waste recycling involves complex decisions inside pharmaceutical GMP facilities, as there are many areas to address.  One simple change would be to swap wood pallets for plastic pallets. Wood generally isn’t the desired material inside a manufacturing facility due to contamination and dust concerns. Additionally, plastic pallets have more reuse cycles than wood pallets.  Manufacturing facilities can also recycle, reuse, or repurpose materials by converting them into energy, which has traditionally been a popular method for eliminating waste.  Pharmaceutical manufacturers can also increase the expiration dates of medicines to decrease the waste stemming from expired goods when sensible.  

3. Consider Employing Zero-Waste Strategies

The goal of examining all possibilities for reducing waste is to integrate waste management practices as a pillar of your business. A zero-waste strategy is devised by systematically analyzing all processes and the associated wastes and then taking actionable steps to reduce waste in each category.  Facility location, material composition, and waste volumes are all crucial factors in determining how much value can be extracted from waste. A zero-waste strategy requires measuring and tracking performance at the manufacturing facility and across the supply chain.   

A Waste Management Reduction Plan Ensures Future Success

As your business matures, waste management will become increasingly important. Implementing long-term plans will prove a successful path for pharmaceutical manufacturers of all sizes.