Guest Column | December 4, 2024

The Building Blocks For Successful CDMO–Pharma Relationships For Packaging Operations

By Ankitkumar C. Patel, senior QA/QC specialist

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To stay competitive, it’s vital for today’s pharma manufacturers to identify cost-effective and environmentally responsible sources for their product packaging. Large vendor contracts are essential to enhancing annual cost ratios, while service agreements help ensure long-term supply chain performance. It’s also important for manufacturers to invest in quality assurance, implement digital inventory systems, focus on staff and client retention, and develop a culture of transparency with clients. By following a comprehensive system of best practices, both the pharma company and packaging manufacturer can achieve significant business growth.

Bringing A Thoughtful Approach To Quality Service Agreements

Quality service agreements between suppliers and clients offer all parties a sense of security. These agreements typically specify a contract length and include a written commitment to deliver products or supplies, often with a financial penalty for delays or failure to deliver. Pharma companies want to ensure they receive their inventory and deliver it to retail stores on time, and while any packaging vendor can make verbal commitments, a service agreement demonstrates a commitment to follow through.

For packagers and manufacturers, service agreements with suppliers higher up the chain offer similar security, enabling them to purchase materials and supplies at more cost-effective pricing for volume orders. They may also include requirements that packaging designs or sizes remain exclusive. Of course, manufacturers and packagers also benefit when agreements include contract periods, and a guaranteed predictable and consistent demand offers stability that makes procuring materials and delivering products more reliable. Service agreements can ensure that inventory arrives at any stage in the supply chain.

Ensuring Reliable Quality

Consistent product quality is critical to staying competitive for pharma manufacturing and packaging operations. Investing in quality assurance and internal audits ensures product quality and builds and maintains customer trust. Quality assurance testing can include sending all bottles through a metal detector before being shipped (as lead is a common issue), frequently validating any measurement tools, and using automated sensors to check for damages to packaging or seals. Frequent internal audits and validation can be supplemented with annual external third-party validation. In addition to ensuring the company meets all required regulatory standards, third-party validation helps develop a reputation for consistency and quality and builds customer trust.

In the United States, meeting Federal Drug Administration (FDA) regulations is a must, but there are additional certifications manufacturers can acquire to demonstrate a commitment to safety and quality while standing out from the competition. For example, International Organization for Standardization (ISO) certification can help organizations gain global market access. NSF’s Good Manufacturing Processes (GMP) for Dietary Supplements certification includes requirements for annual audits, ingredient and raw material testing, sourcing and traceability procedures, and sanitation practices. To achieve the NSF Certified for Sport, companies must first be GMP-certified and then undergo additional “product testing for 290 banned substances, label content confirmation, a formulation and label review, production facility and supplier inspections, and ongoing monitoring.”

Many service providers/partner organizations offer certification, testing, and validation for pharma and biotech products, including validation, purity, seal integrity, and shelf-life testing. Investing in well-recognized third-party certifications helps companies stand out in an increasingly competitive market.

Creating A Culture Of Transparency

A strong relationship with clients built on trust and transparency can be transformative for any pharma manufacturer. Companies that prioritize honesty and do not take shortcuts demonstrate reliability and stability to customers who are likely to trust them now and in the future. A 2023 study in the Business Horizons journal concludes that “transparency serves as a signal and represents the sincerity of a company’s motives.”

While it may feel counterintuitive to a packager to share challenges with its pharma company customers, it’s important that packagers communicate any issues, cost changes, or delays. Pharma companies are more likely to accept necessary cost increases when they understand the background, and when vendors are willing to discuss delays or issues, it increases trust and enables shared problem-solving. Prioritizing the long-term customer relationship over immediate profit is an investment in a packaging organization’s long-term finances and stability.

Key Factors To Consistent Delivery

While transparency is vital if issues or delays arise, minimizing these situations is even more critical for building trust. Maintaining a safety stock of inventory provides a supply buffer should delays occur, reducing the risk of meeting customer deadlines and providing organizations with more time to problem-solve and communicate with customers, if necessary. Today, many pharma manufacturers and packagers use digital management systems to track inventory, coordinate with shipping partners, and quickly detect damaged or flawed products before they go out. It’s crucial for companies to stay abreast of new technology trends that improve inventory management and quality control.

Serial and lot tracking capabilities are equally important to managing recalls and customer complaints more effectively. Organizations can quickly identify potential issues if an error is traceable to a specific lot. Should a pharma company or end consumer raise a complaint, it’s essential for the CDMO or packaging facility to address the issue directly and take steps to demonstrate it will not happen again. Inventory buffers may prevent or minimize disruption to the schedules.

The types of materials and machinery manufacturing and packaging companies use can reduce delays and maintain inventory. For example, by using U.S.-manufactured machines, companies can develop closer relationships and better service agreements with manufacturers and minimize potential downtime for repair. Using U.S.-sourced materials for manufacture and packaging also shortens the supply chain, eliminating potential points of delay and disruption.

Building solid relationships with clients and vendors based on trust and quality allows pharma packaging manufacturers to invest in enhanced safety, innovation, and employee retention. Reliability is essential for any organization, especially when health and safety are critical business components. Clients and consumers trust packagers and manufacturers to meet rigorous standards, and committing to transparency throughout the production process creates a solid foundation for long-term partnerships.

About The Author:

Ankitkumar C. Patel is a senior quality assurance/quality control specialist in pharmaceutical packaging. His expertise includes technical documentation, performance reporting, batch oversight, and quality- and process-improvement initiatives. Patel holds Bachelor of Pharmacy and Master of Pharmaceutical Chemistry degrees from Fairleigh Dickinson University. He can be reached at ankit3374@yahoo.com.