Pharmaceutical Quality Agreement

FDA recommends a quality agreement but does not require it. Its 2016 guidance is nonbinding, and "should" there means recommended (FDA, Quality Agreements guidance, November 2016). ICH Q7 section 16.12 says there "should be a written and approved contract or formal agreement" for contract manufacturers. EU GMP Chapter 7, in EudraLex Volume 4, makes a written contract mandatory. Check the rules in your market.

Four points from the FDA guidance carry the weight:

• The owner's quality unit (the group that approves or rejects product) is legally responsible for approving or rejecting contract-made product, including final release.
• A quality agreement "cannot be used to delegate" CGMP responsibilities. In FDA's own examples, a contract facility whose batch records were inaccurate stayed in violation even though they matched the agreement, and an owner that never audited its testing lab was exposed to citation despite a written two-year audit procedure.
• Confidentiality, pricing, delivery terms and limits on liability stay out.
• Inspectors may review the agreement.

FDA says most quality agreements contain five sections: purpose and scope, definitions, resolution of disagreements, manufacturing activities, and the agreement's life cycle and revisions. The manufacturing section covers six areas: quality unit activities, facilities and equipment, materials management, product-specific considerations, laboratory controls, and documentation (FDA guidance, section IV.B).

Change control gets its own list of 11 change types to report and approve. They include components and their suppliers, establishment locations, manufacturing processes, testing procedures and container closure systems.

For APIs, the Active Pharmaceutical Ingredients Committee (APIC), an industry body that publishes voluntary guidance, offers a ready template. Version 3 (January 2024) divides responsibilities into 25 topics. The template's responsibilities table has about 150 numbered clauses, counting distinct clause numbers in the January 2024 version. As of October 2026, FDA's November 2016 guidance and APIC version 3 (January 2024) are the current versions. The parent standard is ICH Q7, the International Council for Harmonisation guideline on good manufacturing practice for APIs. Section 16.12 calls for a written, approved agreement that defines each party's GMP responsibilities in detail (ICH Q7).

APIC recommends a three-way agreement among the API manufacturer, the distributor and each end customer. The alternative is one agreement between manufacturer and distributor and another between distributor and customer. A direct manufacturer-to-customer agreement is not recommended, because the two share no business relationship (APIC v3, section 3.2).

Two ways to sign with a distributor

Whatever the structure, ICH Q7 section 17 applies to any party that trades, repacks, relabels or stores an API without having made it. That party must keep the original manufacturer's name and address, the manufacturer's batch number, and every authentic certificate of analysis (COA) from the original manufacturer. It must also pass quality and regulatory information both ways. The comparison of API manufacturers, distributors and contract development and manufacturing organizations (CDMOs) shows how those roles differ.

Treat each clause as a claim and collect the evidence behind it. The December 2025 letter shows why. The distributor's vendor survey recorded a "satisfactory" FDA inspection of its supplier that never took place. The agreement's stability clause had no data behind it. FDA called this a failure of the distributor's system for evaluating suppliers (FDA warning letter).

The checks below are a working test built from FDA, ICH Q7 and APIC. For COA review, see how to read an API COA.

How do you test the named-site clause?

Pass: manufacturer name, address and batch number on the COA and shipping papers match the manufacturer named in the agreement (records required by ICH Q7 17.20; matching them to the agreement is a recommended practice). Fail: the manufacturer is unnamed or differs on the documents.

How do you test the change-notice clause?

Pass: a stated number of days before implementation, for example 30 or 60, agreed with your quality unit (a recommended practice). Fail: wording left descriptive. APIC states only "a reasonable time, prior to implementation".

How do you test the audit clause?

Pass: on-site access at the manufacturer, or an agreed third-party report, with audit frequency set by risk. APIC 4.05 defaults to no more than once every three years absent critical incidents, and APIC note 4.3 says shorter intervals, every one or two years, are common for single-source or exclusive APIs (APIC 4.01, 4.05). Fail: audit limited to a trader's office.

How do you test the release clause?

Pass: deviations and out-of-specification (OOS) results are closed before release (APIC 9.02). Fail: a COA is issued with open investigations.

How do you test the stability clause?

Pass: you hold the stability report the clause promises. Fail: the clause is present and the data are missing.

How do you test the recall clause?

Pass: recall information within two business days of a request (APIC 25.03), with named contacts. Fail: no contacts or timeframe.

How do you test the subcontracting clause?

Pass: no work passed to a third party without your prior approval (ICH Q7 16.14). Fail: the agreement is silent on subcontractors.

How do you test supplier statements?

Pass: questionnaire answers, such as inspection history, are checked against public records. Fail: answers are accepted unchecked.

A quality agreement assigns CGMP duties, while the supply agreement holds price, volume and delivery. A quality agreement is also not an audit, a supplier questionnaire or a COA. Those are evidence you collect against it. A third-party manufacturing quote and vetting pack shows how the commercial and quality documents sit together.

We are an API supplier, sourcing partner, distributor and exporter of steroid, peptide, hormone and general pharmaceutical APIs. Supply depends on the approved manufacturing source for each product. As a supplier and distributor, we are the kind of party ICH Q7 section 17 covers, so the checks above apply to us as they do to any distributor.

Our quotation asks for product or CAS number (Chemical Abstracts Service registry number), quantity, destination, grade or purity, documents, payment terms and Incoterms (international shipping terms). Available documentation may include COA, specifications and SDS/MSDS (safety data sheet) where applicable. Evaluation quantities are available to qualified B2B buyers. State whether you need a quality agreement in your inquiry. Whether one can be signed, and with which approved manufacturing source as a party, is confirmed product by product at quotation. See also our qualification map for US importers.

Send your inquiry through our contact form, by email at sunil@aarisepharma.com, or by WhatsApp or phone at +91 9899783330.