How to Choose Between Pharmaceutical Contract Packaging Companies

Most packaging tenders are decided on a price per thousand and a lead time. Both are the wrong place to start. The cost of a poor partner rarely shows up in the unit rate. It shows up as a batch held for weeks because the Qualified Person was unavailable, or a market you cannot supply because your packer cannot serialise.

Pharmaceutical contract packaging companies vary enormously in what they are authorised and equipped to do, and the differences are not visible from a website. This guide sets out the criteria that matter to a procurement or supply chain lead, and ends with a question list for your site visit.

Start with the licences

Licences are binary. A site either holds an authorisation or it does not, and commercial goodwill is no substitute. Five are worth checking against the MHRA register and the supplier's own certificates before you look at price:

• MIA (Manufacturer's / Importer's Authorisation). Required by anyone packing a licensed human medicine in the UK.
• WDA(H) (Wholesale Dealer's Authorisation, Human). Required to store and distribute released product. A site holding only an MIA hands your stock to a third party once the batch is certified.
• FDA registration. Needed if any product is destined for the United States. It is an additional obligation a site takes on and renews annually, so confirm it explicitly rather than assume it.
• Home Office controlled drug licence. Required for Schedule 1 to 5 handling under the Misuse of Drugs Regulations 2001. Ask which schedules are covered, not just whether a licence exists.
• MHRA API storage licence. Relevant if you need active ingredient held alongside finished product.

Central Pharma holds all five at its Bedford site. It is the combination rather than any single licence that determines how much of your supply chain can sit under one roof.

Qualified Person capacity, not just QP presence

Every MIA site names at least one Qualified Person. That tells you very little. What matters commercially is QP capacity: how many are named, whether they are employed or contracted, and what happens to your release date when one is unavailable. A single contract QP visiting weekly is a bottleneck you will feel every quarter.

Ask the turnaround from documentation complete to certification, and whether the site is a named Site of Importation. That matters if you import from outside the UK, because certification must happen at the UK site of importation. Central Pharma has three Qualified Persons and is both a Site of Importation and a Site of QP Release, with product certified to more than 60 countries.

Technology fit and format match

A packer that runs excellent blister lines is not automatically a good home for a pouch product. Match the site's capability to your format, and ask to see the line rather than a brochure.

Cover the primary filling formats you need now and in two years: blister, pot, liquid, pouch and sachet powder filling. On the secondary side, confirm cartoning of blisters, pots and sachets, then the less routine work: rework and repack of finished product, labelling of vials, ampoules and MDIs, kitting and inspection. Probe inspection capability, since a site running AI-based inspection across full output differs materially from one sampling visually.

One site or a chain of handoffs

Count the handoffs from bulk arrival to released, distributed product. Every transfer between legal entities or locations adds transport risk, a goods-in check, an excursion opportunity and a document trail someone must reconcile later. A single site that imports, packs, certifies, stores and distributes carries a different risk profile from a network of four subcontractors. Ask which operations happen on site and which are subcontracted, then read the technical agreements covering them.

Storage conditions available

Confirm the temperature regimes against your product's requirement. Ambient, +2°C to +8°C refrigerated and −20°C frozen cover most conventional pharmaceutical work. Ask about pallet capacity, mapping evidence, continuous monitoring, alarm escalation and out-of-hours response. A site with 10,000-plus pallet locations across ambient, cold chain and frozen, as Central Pharma operates in Bedford, lets you consolidate rather than split inventory.

Serialisation and export market reach

There is currently no mandatory serialisation scheme for the UK domestic market. EU Falsified Medicines Directive safety features ceased to apply in Great Britain on 1 January 2021, and in Northern Ireland from 1 January 2025 under the Windsor Framework.

That makes serialisation an export question. If you supply the EU, the US or other regulated markets, your packer must apply unique identifiers in a 2D DataMatrix, fit anti-tamper devices, aggregate case and pallet hierarchies and exchange EPCIS data. US DSCSA aggregation and interoperable data exchange became enforceable from 28 May 2026. Ask whether serialisation is run by in-house specialists or bolted on through a vendor, and how reworking data is handled when a serialised batch is opened.

Quality history and audit readiness

Request the last MHRA inspection outcome, the deficiency classifications and CAPA closure evidence. A site that answers quickly and without hedging is telling you something useful. Confirm certifications independently: ISO 9001, ISO 13485 if devices are in scope, and whether the quality system is genuinely integrated across manufacturing and distribution or kept as two parallel sets of paperwork. Check that laboratories used for testing are named on the licence.

Project management, capacity and the awkward jobs

Routine repeat packing is easy to quote for. Judge a partner on the difficult work: a launch with a moving approval date, an urgent rework after an artwork error, a recall, or a sudden volume increase.

Establish who your named contact is, whether project management is a dedicated function or a shared inbox, how change control is handled, and what escalation looks like at 4pm on a Friday. Ask for the business continuity plan and where the single points of failure sit: one packing line, one QP, one warehouse. Sustainability belongs in the same conversation, since transport emissions, waste routes and energy use now appear in your own reporting. Electric vehicle fleets and lean programmes are reasonable things to ask evidence for.

Due diligence questions to ask pharmaceutical contract packaging companies

1. Which licences do you hold, and may we see the certificates and MHRA register entry?
2. How many Qualified Persons are named, and what is your certification turnaround?
3. Are you a Site of Importation and a Site of QP Release?
4. Which operations for our product happen here, and which are subcontracted?
5. Which temperature regimes do you operate, and may we see mapping and monitoring records?
6. What was the outcome of your last MHRA inspection, and are all CAPAs closed?
7. How is serialisation resourced, and which market directives have you run in production?
8. Which controlled drug schedules does your Home Office licence cover?
9. Who manages our project day to day, and what is the escalation path?
10. What spare capacity exists, and how fast can you absorb a rework or launch volume?

Key takeaways

• Licences are the first filter: check MIA, WDA(H), FDA registration, Home Office scope and API storage before assessing price.
• QP capacity, not QP presence, sets your real release timeline, so ask how many are named and what turnaround looks like.
• Every handoff between sites or entities adds risk, so count them and read the technical agreements.
• Serialisation is an export requirement for UK packers rather than a domestic one, and DSCSA aggregation has been enforceable since 28 May 2026.
• Judge a partner on rework, recall and launch handling, because routine repeat packing tells you almost nothing.

Talk to Central Pharma about your packaging programme

Central Pharma has been a contract filler and packer since 2006, operating a 267,000 sq ft Bedford site holding MHRA MIA and WDA(H) authorisations, FDA registration for secondary packing and labelling, a Home Office licence for Schedule 1 to 5 controlled drugs and an MHRA API storage licence. Primary filling, secondary packing, serialisation and aggregation, temperature-controlled storage, QP release and onward distribution sit on one site, supported by three Qualified Persons and dedicated project management. To discuss your product, format and markets, get in touch.

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