How should incoming materials be received, quarantined, sampled and released for use?

1What the rules cover.

In the US, 21 CFR 211.80 requires written procedures “describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures”, and those procedures must be followed.¹ In the EU, Chapter 5 of the GMP guide, in its version in operation since 1 March 2015, says receipt, quarantine, sampling, storage, labelling and dispensing should all follow written procedures.² ICH Q7 asks API manufacturers for the same written procedures, with quarantine named explicitly.³

2Check the delivery before accepting it.

On receipt and before acceptance, each container or group of containers is examined visually “for appropriate labeling as to contents, container damage or broken seals, and contamination”.⁴ ICH Q7 adds evidence of tampering, and a check that the supplier’s name for the material matches the in-house name where they differ.³

EU GMP adds document checks. The receiver checks the package’s integrity, including any tamper-evident seal, and that the delivery note, purchase order, supplier’s labels and the approved manufacturer and supplier information all agree. The checks on each delivery are documented, and any damage or other problem that might affect quality is investigated, recorded and reported to Quality Control.² If the supplier of a critical material is not its manufacturer, ICH Q7 expects the manufacturer’s name and address to be known.³ For time- and temperature-sensitive products, WHO’s model guidance also asks the receiver to record any transport delays and the status of attached temperature recorders, and to verify that the required storage and transport conditions were maintained.⁵ How to handle a temperature excursion covers what follows when they were not.

3Code each lot and quarantine it.

Each container or grouping of containers gets “a distinctive code for each lot in each shipment received”, that code is used to record the lot’s disposition, and each lot is identified by status: quarantined, approved or rejected.¹ If one delivery contains several batches, EU GMP treats each batch separately for sampling, testing and release.²

The material then waits in quarantine until it has been tested or examined and released.⁴ EU GMP allows the quarantine to be physical or administrative, starting immediately after receipt.² Labels in the store show the material’s name and internal code, the batch number given at receipt, its status (such as quarantine, on test, released or rejected) and its expiry or retest date; with a fully computerised storage system, not all of that has to be legible on the label.² For bulk materials added to silos or tanks, ICH Q7 says incoming material is identified, tested if appropriate and released before it is mixed with existing stock.³

4Sample and test it.

Each lot is “withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit”.⁶ Representative samples are taken from each shipment of each lot. Sampled containers are cleaned where needed, opened and resealed so as to prevent contamination, and marked to show a sample was taken. Each sample is labelled with the material, lot, container, date and the person who took it, and top, middle and bottom samples from one container are not composited when stratified sampling is needed.⁶ How many containers to sample is covered in raw material sampling plans.

Testing must include at least one identity test on each component, using a specific identity test if one exists. The other specification tests can be replaced by a supplier’s report of analysis only under the conditions set in 211.84(d)(2).⁶ Relying on a supplier’s CoA explains them. EU GMP requires identity testing of each batch of starting material according to Annex 8, and procedures that assure the identity of the contents of each container.²

FDA’s CGMP questions and answers say containers and closures can generally be sampled in the warehouse, but sterile or depyrogenated ones need conditions equivalent to their claimed quality. It also says samples must be taken by the manufacturer after receipt: pre-shipment or “piggyback” samples are generally not acceptable.⁷

5Release or reject it.

A lot that meets its written specifications for identity, strength, quality and purity may be approved and released for use; a lot that does not is rejected.⁶ Rejected material is identified and held “under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable”.⁸ EU GMP allows only starting materials released by Quality Control and within their retest period to be used.²

After release, approved stock is rotated so the oldest is used first, with temporary, appropriate deviations allowed.⁹ Approved material is retested and approved or rejected again when needed, for example after long storage or exposure to air, heat or other conditions that might affect it.¹⁰

6How it runs in Seal.

In Seal, a receipt is matched to the expected material, manufacturer and lot, and each physical container is recorded with its condition and quarantine location. Sampling, results and the use decision stay linked to the containers that arrived, so a container with no identity result or a damaged seal keeps the receipt on hold instead of being lost in the count, and a supplier’s certificate stays distinct from the site’s own results. The raw materials blueprint follows the authorised status, expiry or retest condition and remaining quantity into storage and dispensing.

Location and permission to use are separate facts: moving a held container onto an available-stock rack does not release it, and a decision applies only to the containers it names, as the quarantine location review works through. In inventory, eligibility is checked again at the moment of use, and the execution record keeps the exact container and quantity consumed.