Drugdu.com expert's response:

When doing API foreign trade, you often encounter such inquiries.

The customer has already confirmed the product name and specifications, and has obtained one copy of COA. After one or two rounds of communication, they put forward a new request:
"Could you provide COAs for the latest three batches?"

Some suppliers may feel confused: since one COA already shows all product indicators, why do customers need three consecutive batches?

When a customer starts to review data of consecutive batches, their focus is no longer limited to confirming "whether you have this product", but further judging whether this supplier can be included in their procurement system.

I. One COA Shows Indicators, Multiple Batches Prove Stability

A single COA can only reflect the test result of one specific batch. For customers who plan to make long-term purchases, this is far from sufficient.

Taking APIs as an example, buyers will compare data such as assay, related substances, water content and residual solvents of the latest several batches horizontally. They do not require the figures of the three batches to be completely identical. Instead, they want to verify whether the production and quality control processes are stable, whether any indicator is always close to the limit, or if there are obvious fluctuations between different batches.

The same logic applies to peptide raw materials. Apart from purity, customers may also pay attention to the batch performance of impurity distribution, water content, salt form and other items.

Therefore, when a customer requests consecutive batches of COAs, it usually means their focus has advanced from "product availability" to "supply stability".

II. Buyers Are Also Verifying Quality Standard Consistency

The same API name does not necessarily mean the same procurement requirements.\

Situations that professional buyers will spot easily include: the customer requires EP standard, but the COA provided by the supplier adopts the enterprise's internal standard; the customer focuses on a specific impurity, but this test item is missing in the COA; or the product page marks one specification, while the actual provided COA corresponds to another grade.

Before sending consecutive batches of COAs, it is better to confirm the specific standards required by the customer in advance, for example:

EP, USP, JP or enterprise internal standard

Purity or assay requirements

Whether there are specified impurity control requirements

Whether the final product is used for R&D, registration or commercial production\

If the customer has their own Specification, you can also ask them to provide it first. This way you can judge whether your existing products match their needs, which saves far more communication time than sending a bunch of documents blindly.

III. Buyers Will Also Check the Production Entity on COA

Some enterprises register as trading companies on the platform, but the COAs they provide come from another manufacturing enterprise. Some other suppliers sell the same API from multiple manufacturers.

This does not mean cooperation is impossible, but all information needs to be clearly explained.

In accordance with ICH Q7, the API COA shall reflect the information of the original manufacturer. For agents, traders and distributors, the traceability information of API sources and batches shall also be retained.

When the buyer starts to review the COA carefully, they are very likely to follow up with more questions:

Who is the actual manufacturer?

Does the GMP certificate belong to the same entity?

Has this product been manufactured by this factory for a long time?

Will the subsequent commercial batches still be produced at the same production address?

If suppliers sort out these relationships in advance, the subsequent document communication will be much smoother.

IV. Judge the Procurement Progress Through the 3-Batch COA Request

When receiving such a request, it is not recommended to simply reply with "Please find attached".

You can take this opportunity to confirm more details about the project. For example: "Sure. We can provide recent batch COAs for review. May I also confirm whether this is for supplier qualification, registration or commercial purchase?"

If the customer replies that they are conducting Vendor Qualification, registration declaration or formal supplier screening, you can raise the follow-up priority of this inquiry.

Subsequent requirements such as GMP, DMF, stability data, audit questionnaires and sample testing may come in succession. The sales and quality departments can make preparations in advance, instead of looking for documents temporarily every time the customer raises a new request.

V. Optimize Product Page Display

There is no need to publish all three batches of COAs on the product page, but you need to let buyers know what documents you can provide.

If the API product page only contains the product name, CAS number and the vague description "High Quality", buyers still cannot know to what extent the subsequent quality audit can be supported.

You can add the following information on the page in advance:

Available quality standards

Conventional packaging specifications

Sample support policy

Availability of COA and Specification

GMP and related quality document status

Registration document support capability

Commercial batch supply capacity

When buyers know this basic information before sending inquiries, the first communication will easily move to specific demands, instead of repeated confirmation like "Do you have COA?" or "Do you have GMP?"

VI. Pre-arrange Documents to Improve Response Efficiency

Many API enterprises do not lack relevant documents, but the problem is that the materials are scattered in the sales, quality and production departments.
After the customer requests the latest three batches of COAs, the salesperson has to ask the quality department for the files; when the customer asks for the Specification later, they have to search for it again; when the customer further inquires about GMP, DMF and production address, they need to confirm the information all over again.
If an enterprise plans to carry out overseas promotion, it can sort out a set of basic documents in advance for key product varieties:

Product specifications

Sample COA

Recent batch data

Quality system documents

Packaging information

Production and supply capacity statement

The scope of registration documents that can be provided externally
The purpose of this arrangement is not to send all documents to the customer at one time, but to ensure that the enterprise can respond promptly when the inquiry enters the audit stage.

VII. Final Conclusion

When a buyer requests the latest 3 batches of COAs, in most cases, the inquiry has gone a step further than a simple price inquiry.

They may be checking batch stability, verifying quality standards and production entities, or preparing to include the supplier into their internal audit system. At this point, suppliers can ask less about "when will you place the order", and confirm more about which stage the customer is in: sample testing, supplier audit, registration or commercial procurement.

After clarifying the project stage, you will have a clear idea of what documents to prepare and how much time to invest in this inquiry.