Receiving imported material: what to check before the pallet is accepted
A delivery that has cleared customs is a claim, not yet usable material. Here is the order in which that claim is checked, and what each check settles.
What should you check when imported pharmaceutical material arrives?
Check the documents against the order, the containers against the documents, and the material against its specification. Confirm identity, verify seals, labels, batch numbers and quantity, assess the transport record where storage conditions apply, and hold the whole delivery in quarantine until the quality unit releases it.
A shipment that has cleared customs and reached your yard is not yet usable material. It is a consignment with a claim attached to it, and incoming goods inspection is where that claim meets what is physically on the pallet. Everything upstream exists so that this check can be quick and conclusive rather than guessed at under time pressure.
The work divides into three questions, in order. Do the documents describe the order you placed? Do the containers match the documents? Does the material match its specification? Each carries a different consequence when the answer is no, and collapsing all three into one signature on a delivery note loses the ability to say which of them failed.
What should already be in your hands before the pallet arrives?
A receipt check is only as quick as the preparation behind it. The agreed specification, the analytical method that goes with it, and the approved supplier and site record belong in place long before the shipment moves. So do the batch documents: the certificate of analysis for the batch actually being shipped rather than a typical one, and the packing list.
The site named on those documents matters as much as the results printed on them. A certificate issued by a site other than the one you assessed and approved describes a different supply, whatever the product name on the drum says. Reading that detail is the same skill as reading a GMP certificate, where the address and the scope carry the meaning.
What do you check before the vehicle is unloaded?
The first checks belong to the vehicle, not the material. Confirm that the consignment is the one expected, that the seal is intact and its number agrees with the shipping documents, and that the load compartment is clean and dry. A broken seal, or a number that does not agree, is recorded before anything comes off the truck, because once the pallets are standing on your floor the question of where the discrepancy arose is much harder to answer.
Temperature and transport conditions
Where the material has a defined storage condition, the transport record is evidence rather than a courtesy. Check that the monitoring device travelled with the goods, that it was reading for the whole journey, and that the data has been assessed rather than filed unread. An excursion is not automatically a rejection; it is a decision for the quality unit against the stability data, and the acceptable range comes from the applicable guideline, so confirm the current expectation for your own market and product type.
What do you check on the containers themselves?
With the goods unloaded and held apart from released stock, the check moves to the containers.
Labels, batch identity and quantity
Every container should carry a label that agrees with the certificate of analysis and the packing list on material name, grade, batch number, manufacturer and quantity. Count the containers yourself rather than accepting the packing list figure as a count already performed. Several batches in one delivery are kept apart from the first moment, because a receipt record that merges them cannot be unmerged later. Check the dates too, and know which of the two kinds you are looking at, which our note on retest dates and expiry dates sets out.
Damage, tamper evidence and the container itself
Look at the packaging as an item of evidence. Tamper-evident features intact, outer packaging undamaged, no staining, no crushing, no sign of a container having been opened and closed again. Record the container type: material supplied in a different closure or liner from the one agreed is a change, even when the contents are identical.
Quarantine is a status, not a location. Material is unavailable for use from the moment it is booked in until the quality unit releases it, and the receiving system should make bypassing that impossible rather than merely discouraged. A segregated area helps, but what stops the wrong drum reaching production is a status production cannot override and a label that says so plainly.
What sampling and testing does receipt require?
Receipt testing is not a repeat of the manufacturer's release testing, and not a signature on the manufacturer's certificate either. The purpose is to establish that the material inside the container is what the document says it is. Identity is the check that does that. How many containers are sampled, how the samples are drawn, and whether one container's result may stand for others come from the applicable guideline and your own written rationale, so verify the current requirement for your market and material type.
Sampling needs the care any operation that opens a sealed container needs: a defined area, controlled conditions, cleaned equipment, and a record of which container each sample came from. A container opened and not properly reclosed has had its storage condition changed. Where the specification controls impurities, the certificate is read against it rather than scanned for the word complies, as set out in our note on reading an impurity profile.
What happens when something does not match?
A discrepancy found at receipt is cheap compared with the same discrepancy found in production, so a receiving procedure should make recording one easy and resolving one slow. Missing documents, a short count, a damaged container, a label that disagrees with the certificate: each is recorded against the delivery, assessed by the quality unit, and raised with the supplier formally rather than settled in a message that leaves no trace.
Partial acceptance is a decision, not a convenience. Releasing the undamaged containers and holding the rest can be correct, but it has to be a documented assessment rather than a warehouse judgement made to clear floor space.
What should you agree with the supplier before the shipment leaves?
Most receipt problems are avoidable at the order stage. Agree which documents travel with the goods and which arrive ahead of them, in what language, and who is told when a container is found damaged. Agree the labelling detail, the container type, and how a change to either is communicated. Agree what happens to a rejected consignment, including who pays to return or destroy it. Those points belong in a quality agreement with an API supplier rather than in correspondence.
Document review, label and container checks, and the condition of an arriving consignment are part of what we look at before material is offered, through our API sourcing work and separately through our consultancy service. They read alongside telling a manufacturer from a trading company, which decides whose answers you are really getting.
NJMC Medical Supplies Co., Ltd is a trading and consultancy company in Nanjing, China, supplying medical equipment, medical consumables and active pharmaceutical ingredients to healthcare institutions, sourced from manufacturers in China and India.
Frequently asked questions
Is incoming goods inspection a repeat of the manufacturer's testing?
No. The manufacturer's release testing establishes that the batch met its specification when it was made. The receipt check establishes that what arrived is that batch, in sound condition, with documents that agree. Identity testing is the part that looks inside the container; the rest is document, label and container work.
Can material be moved into production while it is still in quarantine?
No. Quarantined material is unavailable until the quality unit releases it, and the receiving system should enforce that rather than rely on people remembering. If production needs material urgently, the answer is to prioritise the release decision, not to take the drum early and complete the paperwork afterwards.
What do you do if the certificate of analysis arrives after the goods?
Book the delivery in and hold it. The physical checks on the seal, the containers and the labels can all be done, but the comparison that matters needs the batch certificate, so release waits for it. A pattern of certificates arriving late is a supplier performance issue worth raising formally rather than absorbing.
Who should carry out the receipt check, the warehouse or the quality unit?
Both, with the split written down. Warehouse staff do the physical work: vehicle, seal, count, labels, container condition, and recording what they find. The quality unit reviews the documents, decides on sampling and testing, assesses any discrepancy, and is the only function that can move material out of quarantine.
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