My (near) Thirty Year Journey: What Contract Packing Taught Me About a Changing Industry

Where it started

I have spent the best part of thirty years in pharmaceuticals, medical devices and healthcare. The biggest lesson is simple: the product is only as good as the last pair of hands that touches it before the patient does.

When I started, packaging was often treated as the final, slightly unglamorous step. The science happened upstream. Packing was where you put tablets in a box and got them out of the door. Few people outside operations gave it much thought.

That view has not survived contact with the last three decades. Today the pack is a regulated, data-rich, patient-facing part of the medicine itself. It carries the information a nurse reads at 3am on a busy ward. It protects a moisture-sensitive tablet in a humid bathroom cabinet. It proves, through a unique code, that the product in a pharmacist’s hand is genuine. It keeps a biologic stable from the line to the clinic.

Over that time I have sat on both sides of the table: as the person buying services and as the person selling them. I have watched good companies get caught out by regulatory change, and I have watched smaller, sharper partners turn that change into an advantage for their clients. This article is my attempt to set out what has changed, what has stayed the same, and why I believe a good contract packer is now one of the most strategic partners a pharmaceutical, healthcare or medical device company can have. I will finish with where I think we are heading, because the next ten years will move faster than the last thirty.

Thirty years of moving goalposts

If I had to describe the regulatory journey in one phrase, it would be this: from “show me the product” to “show me the data”.

In the 1990s, compliance was largely paper-driven. Batch records were handwritten, line clearances were signed on clipboards, and inspection was mostly the human eye. GMP was rigorous, but it relied heavily on the diligence of individuals. Good companies did it well. Others did it adequately, and adequacy was often enough.

Then the expectations started to stack up…

Data integrity became a discipline in its own right. Regulators stopped asking only whether a record existed. They started asking who created it, when, whether it could have been changed, and whether the change was traceable. ALCOA, and then ALCOA+, moved from a training-slide acronym to the lens through which every record is judged. For a packer, that meant every count, every reconciliation and every label check had to stand up to forensic scrutiny.

The Qualified Person’s role sharpened. Updated guidance on QP certification and batch release made it clear that the QP must have genuine visibility of the whole supply chain, including outsourced steps. That changed the relationship between sponsors and their packaging partners. You could no longer simply hand over a job; you had to be able to evidence control over it.

Serialisation arrived. The EU Falsified Medicines Directive brought unique identifiers and anti-tamper devices onto packs from February 2019. Almost overnight, packing lines needed vision systems, printers, aggregation logic and secure data links that would have looked like science fiction in the 1990s.

Medical devices caught up with medicines. The EU Medical Device Regulation, applied from May 2021, raised the bar on clinical evidence, traceability and labelling, including Unique Device Identification. Device companies that had lived comfortably under the old directives suddenly needed partners who understood both worlds.

Brexit rewrote the map for UK businesses. After January 2021, Great Britain stepped away from EU FMD safety-feature requirements, while Northern Ireland followed a different path. Then the Windsor Framework, effective from January 2025, brought UK-wide licensing and “UK Only” labelling. Every one of those shifts landed on the packaging line as artwork changes, new SKUs and split supply chains.

Sterile and aseptic expectations tightened. The revised EU GMP Annex 1, effective from August 2023, pushed contamination control strategy to the centre of sterile manufacture. Even where the packer is not doing the filling, it changes how ampoules and vials are handled, inspected and documented downstream.

The cold chain grew up. Good Distribution Practice became far more demanding, and biologics, vaccines and cell and gene therapies pushed temperature-controlled storage from a niche into the mainstream.

None of these changes arrived in isolation. They layered on top of each other, often with overlapping deadlines, and they almost always landed hardest on the final steps of the supply chain: packing, labelling and storage.

What “keeping pace” really means for a contract packer

Over the years I have seen two kinds of contract packer. The first treats regulation as a cost to be passed on. The second treats it as a service to be offered. Only the second kind has thrived.

The best packers I have worked with, and the culture we have built at CPCP, share a few habits.

They read the regulations before the client does. A good packer should be the one ringing the client to say, “This change is coming. Here is what it means for your packs, and here is our plan.” When serialisation, MDR and the post-Brexit labelling changes landed, the clients who coped best were the ones whose partners had already done the thinking.

They are licensed and certified for both medicines and devices. At Central Pharma we hold an MHRA manufacturing licence and ISO 13485 certification for medical devices. That combination matters more than ever. Drug-device combination products, diagnostic kits and companion devices increasingly sit across both regulatory frameworks. A partner that only speaks one language will slow you down.

They make the Qualified Person’s job easier, not harder. Electronic, clean, contemporaneous, reviewable records are the single biggest favour a packer can do for a client’s QP. Every deviation explained, every reconciliation closed, every change controlled.

They are flexible without being loose. Trial batches, launch volumes, short-dated recalls, emergency re-labelling, market-specific variants: the modern supply chain is full of small, urgent, awkward jobs. A good packer says yes to them, then runs them with exactly the same discipline as a million-unit commercial order.

They invest ahead of demand. Vision systems, serialisation-ready lines, controlled storage, digital batch records and now artificial intelligence. Each of these was an investment decision made before any client asked for it.

Above all, a good contract packer understands that it is an extension of the client’s own quality system. When the MHRA or a notified body looks at your product, they are, in effect, also looking at us. We take that personally.

With that in mind, I want to focus on four areas where I believe the difference between an average partner and a great one is most visible.

Blister packing: the humble pack that does the most work

The blister pack is one of the most underrated pieces of engineering in healthcare. Hold one up to the light and it looks simple. In reality, it is a carefully specified barrier system, a dosing aid, a tamper-evident seal and a patient-information carrier, all in a few grams of film and / or foil.

Thirty years ago, the conversation was mostly about PVC and aluminium, line speed and cost per thousand. Those still matter. But the questions clients ask today are far richer.

Barrier performance. Modern formulations are often more sensitive to moisture, oxygen and light. Choosing between PVC, PVDC-coated films, Aclar laminates and cold-form aluminium is now a stability decision as much as a packaging one. A good packer helps the client match the material to the molecule, and to the climatic zones the product will travel to.

Patient adherence. Calendar packs, day-of-week printing and clearly perforated unit doses are not marketing extras. They help patients take the right dose at the right time, and adherence is one of the biggest unsolved problems in medicine.

Child resistance and senior friendliness. Peel-push and child-resistant designs have to keep children out while still letting an arthritic hand get in. Getting that balance right takes testing, not guesswork.

Sustainability. This is the newest and fastest-moving pressure. Clients increasingly want lower-carbon, recyclable or mono-material blister options, and they want to understand the trade-off against barrier performance before they commit.

Inspection. In the past, an empty pocket or a broken tablet might be caught by an operator’s eye or a simple sensor. Today, camera systems inspect every pocket, every print and every code at full line speed. That is where artificial intelligence is now making a real difference, which I return to below.

What has not changed is the discipline. Line clearance, reconciliation, foil print verification and in-process checks are as important now as they were in 1997 when I started working in the industry. The technology has improved. The responsibility has not moved an inch.

For clients, the value of an experienced blister partner is in that combination: deep, hands-on process knowledge alongside the willingness to adopt new materials and new inspection technology as soon as it is proven.

Specialist storage: the part of the supply chain nobody sees until it fails

Storage used to be described as “warehousing”. That word no longer does it justice.

The products moving through healthcare supply chains today are more valuable, more sensitive and more tightly regulated than ever. A single pallet of a biologic can be worth more than a house. A temperature excursion of a few hours can write it off. A gap in a security log can trigger an investigation.

The practical consequence is that storage is now part of the product’s quality story. Regulators expect the same rigour in the store as on the line.

Temperature control and mapping. Controlled room temperature, refrigerated and frozen storage must be qualified, mapped across seasons and continuously monitored. Alarms need to reach a person who can act at any hour, and every excursion needs a documented assessment.

Controlled drugs. Storing controlled substances requires Home Office licensing, secure vault facilities, strict access control and meticulous record-keeping. Few contract packers are equipped for it, and fewer still can integrate it smoothly with packing and labelling. At Central Pharma, our vault capability lets clients keep controlled products under one roof from receipt to dispatch with visibility provided electronically in near real time.

Segregation and status control. Quarantine, released, rejected, returned and recalled stock must be physically and systemically separated. In the past this relied on coloured labels and cages. Today it relies on validated warehouse systems with full audit trails, backed by the physical controls.

Stock that waits for a decision. Post-Brexit labelling changes, market withdrawals and pack redesigns have all created stock that is perfectly good but cannot ship as it is. Holding that stock securely, then re-working, over-labelling or re-packing it under GMP, is one of the most valuable services a packer can offer. It turns a write-off into a saleable product.

The lesson I have learned is that clients rarely choose a storage partner because of square footage. They choose one because they trust what happens inside it, and because storage, packing and labelling under one quality system removes handovers, transport risk and paperwork.

Ampoule and vial labelling: small surfaces, high stakes

If blister packing is underrated, ampoule and vial labelling is underestimated. The label on a 2ml ampoule might be the last thing a clinician reads before injecting a patient. There is no margin for error.

I have seen this area change enormously.

More information, less space. Product name, strength, route, batch, expiry, and increasingly a 2D code all have to fit legibly on a tiny curved surface. Getting that right is an exercise in artwork design, label stock selection and print technology working together.

Fragile containers, demanding materials. Glass ampoules break. Vials come in a range of sizes and finishes. Some products are labelled straight from cold storage, which brings condensation and adhesion challenges. Labels must survive refrigeration, handling and sometimes freezing, without lifting, smudging or wrinkling.

Zero tolerance for mix-ups. Look-alike, sound-alike products and multiple strengths of the same molecule are a well-known source of medication errors. The defence is a combination of strict line clearance, one product per line, and 100% automated verification of every label: text, barcode, batch and expiry.

Re-labelling as a service. Market changes, regulatory updates and supply shortages often mean stock needs to be re-labelled for a different market or with corrected information. Done properly under GMP and with the right QP oversight, this keeps essential medicines moving to patients who need them.

What clients value here is calm competence: a team that has labelled millions of ampoules and vials, treats every one as if it were the only one, and has the inspection technology to prove it.

Artificial intelligence: from buzzword to the packing line

I have seen plenty of technology waves arrive with great fanfare and leave little behind. Artificial intelligence is different. For the first time in my career, I am seeing a technology that improves quality, speed and cost at once, and does it on the shop floor rather than only in the boardroom.

At Central Pharma we have approached AI in two ways: using it to run our own business better, and packaging what we have learned into services our clients can adopt on their own sites.

AI inside our own operations

AI-enabled electronic batch records. Paper batch records have been the backbone of GMP for decades, and the source of a large share of its errors: missed signatures, illegible entries, transcription mistakes and slow review. Our AI eBPR system captures data at the point of work, checks it in real time and flags anomalies before they become deviations. The result is right-first-time records, faster batch review and a much happier QP.

AI vision inspection. Traditional rule-based vision systems are good at what they are explicitly told to look for. AI-based inspection learns what “good” looks like and can spot subtle defects that fixed rules miss, from a dented aerosol canister to a marginal print on a label. It also reduces false rejects, which quietly cost manufacturers a great deal of good product.

Faster, better-informed decisions. Behind the scenes, AI tools help our teams analyse trends, prepare documentation, respond to customer enquiries and spot patterns in quality data that would take a person days to find.

Crucially, none of this replaces human judgement or GMP accountability. Every system is validated, every decision that matters still has a named person behind it, and data integrity principles apply to AI just as they do to a clipboard.

AI as a service to clients

The most exciting development for me is that this is no longer only something we do. It is something we offer.

We now help manufacturers install AI eBPR systems across their own production sites, configured to their SKUs and processes. We also design and supply AI inspection solutions, including dedicated inspection lines, for products where conventional vision systems struggle. For clients who want to test the value before committing, we can structure trial periods so the evidence comes from their own works orders, not our sales slides.

This is a natural extension of what a good contract packer has always done: absorb the operational complexity so our clients can focus on their science and their patients. The difference now is that the expertise we have built on our own lines can travel to theirs.

The next ten years

If the last thirty years taught me anything, it is that the pace of change only accelerates. Looking ahead, I see a handful of forces that will shape our industry.

• Personalised and smaller-batch medicine. Advanced therapies, orphan drugs and tailored dosing will mean more SKUs, smaller runs and tighter timelines.
• Sustainability as a regulatory requirement. Packaging waste rules and customer expectations will push the industry towards recyclable and lower-carbon formats, without compromising protection.
• Digital patient information. Electronic leaflets and smart codes will gradually change what goes on, and in, the physical pack.
• AI as standard practice. Within a few years, I expect AI-assisted batch records and inspection to be the expectation of regulators and clients, not a differentiator.
• Resilient, local supply. The pandemic and Brexit both showed the value of capable UK-based partners who can respond quickly when global supply chains wobble.

The contract packers that thrive will be the ones who combine deep GMP heritage with genuine curiosity about what comes next. That is the balance we work hard to strike at Central Pharma.

Let’s talk

After nearly three decades, I still find this industry fascinating. Every pack we produce ends up in the hands of someone who needs it, and that has never stopped mattering to me.

If you are a pharmaceutical, medical device or healthcare company looking for a partner in blister packing, specialist and controlled-drug storage, sachet packing, bottle filling, ampoule and vial labelling, or AI-enabled batch records and inspection, I would be glad to hear from you. Whether it is a launch, a re-labelling challenge, a capacity gap or simply a conversation about where AI could help your own operation, please get in touch.

Contact: Ian Robinson, Group Business Development Director, Central Pharma (CPCP), Bedford

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