FDA compliance for pharmaceutical manufacturers and API suppliers.

CGMP is the centre of gravity

Finished pharmaceuticals are governed by current good manufacturing practice under 21 CFR 210 and 211; active pharmaceutical ingredients are held to the standard described in ICH Q7. Both are enforced through inspection, and both are judged on records as much as on facilities: batch production records, deviation and investigation files, stability data, cleaning validation, water systems, and the integrity of the data behind all of it.

Data integrity findings — shared logins, uncontrolled spreadsheets, deleted chromatograms, testing into compliance — have become the most damaging category of observation for foreign facilities, because they call every other record into question.

Registration, listing and marketing authorisation

• Establishment registration and drug listing with annual renewal, and a United States agent for foreign establishments.
• An approved application — NDA or ANDA — or a valid OTC monograph route, before the product may be marketed.
• Drug Master Files where an API supplier supports a customer's application.
• Labeling, and for many products the serialisation obligations under the Drug Supply Chain Security Act.

When the facility itself is listed

A facility that is found significantly out of CGMP compliance, or that refuses, delays or limits an inspection, can be placed on an import alert covering everything it makes. Removal follows the same logic as any other alert: an honest root cause, remediation a third party can verify, and a petition that presents the evidence rather than asserting it.

What we do

• CGMP gap assessments and inspection readiness.
• Remediation programmes with sequencing a site can actually execute.
• Data integrity assessments across laboratory and production systems.
• Drafting responses to Form 483 observations and Warning Letters.
• Drug Master File preparation and maintenance.
• Import alert removal petitions prepared for listed sites.

Common questions

What triggers the CGMP import alert?

Typically a significant CGMP finding at inspection, or refusal, delay or limitation of an inspection. The listing covers the facility, which means every product it makes is affected — not only the one that was inspected.

Can a third-party audit satisfy FDA?

A credible third-party assessment is normal and often expected as part of remediation. It supports the case; it does not replace FDA's own judgement, and an audit that reads as reassurance rather than assessment carries little weight.

How is an API supplier's position different from a finished dose manufacturer's?

The regulatory hooks differ. API suppliers are usually reached through their customers' applications and drug master files and are inspected against ICH Q7, while finished dose manufacturers are inspected against 21 CFR 211 and hold the application themselves.

We are a contract manufacturer. Whose responsibility is compliance?

Both parties'. The application holder is responsible for the product and the contract facility is responsible for its own CGMP compliance. A quality agreement allocates the work; it does not transfer the liability.