Packaging and Supply Chain Challenges for CMOs

Packaging and Supply Chain Challenges

Delivering lifesaving pharmaceuticals to those in need is crucial, especially in the fast-paced healthcare environment. Pharmaceutical Contract Manufacturing Organisations (CMOs and CDMOs) play a vital role in ensuring medications reach patients effectively. At Adelphi, we are proud to support many of these organisations worldwide with our primary packaging and consultation services. By fully understanding our customers' needs, we strive to provide the best possible support, especially as we learn about the challenges these essential companies face in the global medical supply chain.

In this article, we will discuss the most common packaging and supply chain challenges highlighted by our customers. We will address issues like booking-in delays and the complexities of Annex 1, while also exploring solutions and opportunities for improvement.

In short, we recommend working with the right supplier to alleviate your challenges.

So, let’s get started with the obstacles:

Supply Chain Challenges

Availability of consumables

You almost certainly will have had a situation where a client has stipulated that you must use a specific packaging component. And, when you’ve tried to source this component for production you find

it’s not a stocked item, and has a huge MOQ and a terrifyingly long lead time.

Now, obviously, if the client specifically wants that unique vial or stopper, they will need to accept the situation for what it is. But it does highlight the value of product availability.

When clients aren't limited by specific product attributes, many of our CMO customers will recommend packaging components from a selection of trusted options. These are items they have used repeatedly and know can be processed on their existing machinery, eliminating the need for costly changeovers. This also ensures that these components are readily available from stock or can be obtained within a reasonable lead time from reliable suppliers. Additionally, they can be confident of the compatibility of these items, for example a vial and stopper that work well together to provide excellent container closure integrity (CCI).

It is important when considering a new packaging supply partner that you can be confident of their product range and their stock holding capacity. Selecting a reliable partner with a consistent inventory of trusted, readily available packaging components can save you from having to hold your own stocks, therefore freeing up your working capital.

Batch Traceability

Having full batch traceability means understanding the exact origins of each of your components. All packaging items can be traced back to a production batch, lot, or even a specific pallet of goods. This means that any production defects or concerns can be narrowed down and a batch review performed to assist in identifying the root cause.

Batch traceability goes back not only to the production of the packaging component itself, but also its ingredients and their origins.

If a problem batch is identified, it's important that the supplier is able to match these batch details to the customers who have purchased the goods and inform them quickly of any concerns.

Understandably, the pharmaceutical industry has a huge responsibility to ensure the safety of their products, and ultimately their patients. Despite rigorous testing at various drug development stages, there are instances where it will be necessary to recall drugs from the market. Common reasons for drug recalls include:

- Inadequate compliance with cGMP

- Bacterial contamination

- Incorrect labelling

- Improper storage

Being able to trace a product back to its origins helps identify the item, process, or ingredient that may have caused a recall.

Your packaging supplier should keep thorough batch records to ensure full traceability of the supply chain.

Certificates of Conformity

Now, one of the biggest complaints our CMOs mention is delayed access to Certificates of Conformity.

A Certificate of Conformity (CoC) is a document that confirms a product meets certain standards, like those in global pharmacopeia, and shows how it matches the manufacturer's specifications. The Goods-In department of any Contract Manufacturing Organisation must have the Certificate of Conformity in place in order to book in goods. Our customers tell us that CoCs have been difficult to get from some suppliers, and as a result they have been unable to book in goods, resulting in production delays. This not only throws off production planning, but also affects your clients, and ultimately the patient.

When selecting a new supply partner, ask them how long after a delivery you can expect to receive certification. At Adelphi we email Certificates of Conformity on the day of shipment, meaning no booking in delays, and less stress for our customers.

Access to Documentation

If you’re a CMO serving the pharmaceutical industry, you will know the importance to your clients of having all necessary documentation to ensure packaging product meets the relevant quality and regulatory criteria. Such documentation might include:

- Technical drawings

- TSE/BSE Statements

- Manufacturer ISO certification

- ICH Q3D Compliance statements

- Nitrosamine data

The ability to supply this documentation on demand increases your clients’ confidence in your understanding of the industry, and your commitment to best serving their needs.

At Adelphi we keep this documentation on file, ready to send to you on request. If your client has a less common request, strong relationships with our partners mean we can get you quick answers, helping you to support your excellent relationship.

Implications of Annex 1

The Challenge of Tighter Regulations

Recent updates to EU GMP Annex 1 have seen more stringent processes and a greater onus on the manufacturer to implement and maintain the highest aseptic processing standards. Detail of the updates is covered in our article, The Impact of Annex 1 for Pharmaceuticals. Below is a brief overview of the main changes:

Media Fill or Aseptic Process Simulation (APS): Annex 1 updates have made this procedure mandatory not just for liquid-based products but also for non-filtered formulations, sterile powders, and lyophilised (freeze dried) products.

Cleanrooms: Annex 1 mandates cleanroom particle levels are monitored to between 5.0 - 0.5 micrometres.

Barrier technologies: such as isolators, filtered vacuums and restricted-access barrier systems are now required to provide suitable protection for housing stable Grade A environments.

Disinfection: It is compulsory to both document and frequently clean post and pre-production to achieve an above satisfactory level of contamination control.

Annex 1: A Blessing in Disguise?

Contract Manufacturers are in the fortunate position of already having extensive experience in process validation and sterile manufacture. They are used to adapting to client requests and the requirements of the applicable pharmacopoeia. This adaptability and expertise means they will acclimatise to the changes more easily than smaller inhouse pharma manufacturing units. Many of whom will be looking to outsource their drug manufacturing processes in light of the Annex 1 updates, and CMOs will see increased demand for their invaluable services.

Innovations in the primary packaging industry are helping to make the transition even smoother. Pre-washed, sterilised and ready-to-use components are increasing in popularity and remove the need to use inhouse washing and sterilisation equipment. This is especially useful for small batch production where the cost of setting up and running such equipment is not practical for lower production volumes.

Adelphi stocks a range of clean, sterile and ready-to-use packaging, ready for immediate shipment worldwide.

view our range of sterile and ready-to-use vials, stoppers and crimp seals

The Future of Contract Manufacturing is Partnership

So, while there are both supply chain and regulatory challenges to be faced, it's clear that partnering with a reliable packaging supply partner will make the journey a much smoother one.

In summary, a great packaging supplier:

- Has a deep understanding of the pharmaceutical industry

- Provides timely updates on order progress

- Stocks the most commonly used primary packaging components you need

- Ships goods quickly, wherever you are in the world

- Has strong partnerships with major global packaging manufacturers

- Provides quick access to all the regulatory documentation your clients need

- Submits Certificates of Conformity in advance of every delivery

- Keeps on top of the latest product innovations

At Adelphi, we pride ourselves on our dedication to customer satisfaction. We commit to offering all of the above and more. But don’t just take our word for it: read real customer feedback and testimonials on our Adelphi Testimonials page.

If you think Adelphi could help you with your current or future projects, please don’t hesitate to reach out to our friendly, expert team: Contact Us, or browse Our Product Range.