Drugdu.com expert's response:

When exporting APIs, pharmaceutical intermediates and pharmaceutical excipients, suppliers often encounter situations where overseas buyers request a COA (Certificate of Analysis). Some customers only ask for one COA to gain a preliminary understanding of product quality, while others, after confirming product specifications, further express their wish to review the COAs of the latest three batches.

For suppliers, a single COA is usually easy to provide, but consecutive three batches of COAs involve actual test data from different production batches, which requires more careful preparation.

Why do buyers want to see three batches? Does it mean their procurement intention is relatively clear? If there are differences in the test results of different batches, will it affect the buyer's judgment?

These problems are very common in overseas procurement of pharmaceutical products such as APIs.

Why do buyers request the COAs of the latest three batches?

For pharmaceutical enterprises with clear procurement needs, judging whether a raw material is qualified usually does not only focus on the test results of a single batch.

For example, an overseas pharmaceutical factory is evaluating a new API supplier. In the first round of communication, the procurement staff may only need to confirm the product name, CAS number, quality standards and quotation. If the product meets the preliminary requirements, the quality department may further request the COAs of the latest several batches to check whether the actual test results of the product are stable and whether there are significant differences between different batches.

A single batch COA can reflect the quality of that specific batch of products, while multiple batches of COAs help buyers observe batch-to-batch consistency.

Especially for key indicators such as assay, related substances, water content and residual solvents, buyers may not only pay attention to whether they meet the specified limits, but also compare the test results of different batches. If a certain impurity fluctuates greatly between different batches, even if all test results are within the standard range, it may arouse further attention from the quality department.

Of course, the indicators that different products focus on are not exactly the same. The quality control requirements for APIs, pharmaceutical intermediates, excipients and peptide raw materials are different, and buyers need to conduct evaluations in combination with product uses, applicable standards and internal quality requirements.

The request to provide the COAs of the latest three batches may mean that buyers have begun the initial supplier screening or quality assessment, but it cannot be directly judged that the other party is ready to place an order. Some customers are just collecting documents in accordance with their internal supplier access procedures, or may be evaluating multiple suppliers at the same time.

When preparing three batches of COAs, it is not enough to only ensure their availability. We also need to check whether the documents can correspond to each other.

When suppliers prepare consecutive batch COAs, they must first confirm the authenticity, completeness and traceability of the documents.

According to ICH Q7 GMP requirements for APIs, a COA should include the product name, applicable quality grade, batch number, release date, relevant test items, acceptance standards and actual test results, and be signed by an authorized person from the quality department. Relevant documents should also be traceable to the original manufacturer.

For suppliers, before providing three batches of COAs, they need to focus on checking whether the product names, specifications, quality standards, production entities and document versions are consistent.

For example, the three COAs of a certain API adopt different versions of quality standards respectively, or have differences in test items. Enterprises cannot simply send the three documents together. Instead, they should first confirm the reasons for the differences, whether they involve standard updates, test method adjustments or product specification changes.

If a certain batch adopts a new test method, or the limit of a certain quality indicator is adjusted, relevant changes and their basis should also be explained.

Another situation that requires attention is that the production entities of different batches are inconsistent.

For enterprises with multiple production bases, cooperative factories or simultaneous trading businesses, the three COAs may come from different manufacturers. Even if the product names are the same, these documents cannot be directly used as proof of the quality performance of consecutive batches from the same production source.

Especially for APIs used for pharmaceutical registration, supplier audits or long-term procurement projects, buyers often need to confirm whether subsequent commercial supplies come from the same production entity, and whether the submitted quality documents can correspond to the actually purchased products.

If the production source changes, suppliers should truthfully explain the situation, instead of mixing test reports from different sources to mislead buyers into thinking that these data come from the same production system.

Will differences in test results affect buyers' procurement decisions?

It is not uncommon for the actual test results of different batches to have certain differences. The key lies in whether the differences are within a reasonable range, whether they meet the approved or agreed quality standards, and whether the enterprise can explain abnormal fluctuations.

For example, the assay test results of three consecutive batches of the same API are 99.2%, 99.5% and 99.3% respectively. If all of them meet the applicable standards, and the test methods, sampling and other relevant conditions are consistent, such differences may not affect the buyer's judgment.

However, if the content of a key impurity is relatively low in the first two batches and close to the specified limit in the third batch, buyers may further inquire about the reasons, and even request more batch data or relevant quality trend analysis.

For pharmaceutical factory customers, product compliance with release standards is only part of the supplier audit. Batch stability is also related to subsequent pharmaceutical production, process adaptation, quality control and continuous procurement.

Therefore, suppliers should not modify actual test results to make the documents look neater, nor arbitrarily select the three batches with the best test data and pass them off as the latest three batches.

If there are abnormalities, deviation investigations or quality standard changes in the latest batches, enterprises should complete internal quality assessments according to the actual situation, and provide accurate explanations to buyers within an appropriate scope.

When traders provide COAs, they also need to pay attention to production source and authorization issues

In pharmaceutical B2B trade, many inquiries are handled by trading companies or distributors, but the actual products come from cooperative manufacturing enterprises.

This cooperation model is not problematic. However, when buyers request consecutive three batches of COAs, traders need to confirm whether they can obtain real, complete and traceable documents.

For example, a trader quotes a certain API to an overseas customer, and the provided COA comes from a cooperative factory. When the buyer further requests the latest three batches of data, the trader needs to confirm with the manufacturing enterprise whether relevant batch records are available, whether the documents are officially issued, and whether the subsequent supplied products come from the same production source.

If the COA is reissued by a trader, agent or repackaging enterprise, it should also comply with applicable quality management requirements, and retain the traceability relationship of the original manufacturer information and original documents. ICH Q7 and its question-and-answer documents also emphasize that the COA in the API supply chain should be traceable to the original manufacturer.

Some suppliers are worried that their documents will be used by other traders, so they are unwilling to provide complete information in the first round of communication. This concern is understandable, but commercial risks should be managed by confirming the buyer's identity, clarifying the purpose of the documents, and signing necessary non-disclosure agreements, rather than arbitrarily deleting key information in the documents that affects authenticity and traceability.

For customers still in the preliminary inquiry stage, enterprises can first provide product specifications, appropriate COA samples or document support descriptions. After buyers clarify the product uses, quality audit requirements and procurement projects, they can coordinate to provide official consecutive batch documents.

After sending out the three batches of COAs, we also need to observe whether buyers push the project forward

The request for consecutive three batches of COAs involves more quality information than a simple price inquiry, but the quality of the inquiry cannot be judged solely by this point.

If buyers, after receiving the documents, continue to discuss quality standards, production processes, impurity control, sample testing, supplier audits or commercial batch delivery, it usually indicates that the procurement assessment is further expanding.

If customers ask multiple suppliers to provide COAs at the same time, but do not specify the procurement quantity, purpose or target market, it may only be preliminary document collection.

For suppliers, they can judge whether this inquiry is worthy of key investment by combining the buyer's identity, procurement background, product specifications and subsequent communication progress.

For API and pharmaceutical raw material enterprises that have already carried out overseas promotion, sorting out the specifications, COAs and relevant quality documents of core products in advance is also conducive to improving subsequent communication efficiency. On professional pharmaceutical B2B platforms such as Drugdu.com, enterprises can clearly display product names, CAS numbers, quality standards, specifications and available document types on product pages, so that overseas buyers can have a preliminary understanding of the enterprise's supply capacity before sending inquiries.

However, consecutive batch COAs are specific quality documents, which may not be suitable for full public display. Especially when involving production entities, customer-specific specifications or sensitive batch information, enterprises should arrange the provision according to the nature of the documents and the cooperation stage.

Overseas buyers' request for the latest three batches of COAs indicates that they hope to gain a deeper understanding of product quality, but whether the procurement project is mature still needs to be judged in combination with other information.

For suppliers, the most important things to focus on when preparing three batches of COAs are ensuring the authenticity of documents, traceable batches, clear quality standards, complete test results, and the consistency between the production entity and subsequent actual supply.

If enterprises can clearly explain the quality performance of different batches and provide reliable document support, they can establish a better communication foundation for subsequent supplier audits, sample testing and commercial procurement.