GMP Compliance and GMP Inspections for Drug Makers

What GMP compliance means in practice

GMP compliance means your facility, processes and records meet 21 CFR Parts 210 and 211 (or ICH Q7 for APIs), every day, not just before an inspection. Noncompliance has a legal consequence: “any drug it makes is considered ‘adulterated’ under the law” (FDA).

Inspections are where compliance is tested, and they are becoming harder to prepare for at the last minute. FDA announced on May 6, 2025 that it would expand unannounced inspections at foreign facilities (Hogan Lovells).

How FDA structures a drug GMP inspection

FDA organizes drug manufacturing inspections around six systems. In its API inspection program (compliance program 7356.002F, issued August 1, 2025), FDA defines them this way (FDA):

System	What investigators examine
Quality	Overall CGMP compliance, procedures, investigations, CAPA, change control, annual reviews
Facilities and equipment	Buildings, utilities, equipment qualification, cleaning, maintenance and calibration
Materials	Control of starting materials, intermediates and containers, including supplier qualification
Production	Process controls, in-process sampling and testing, batch records and process validation
Packaging and labeling	Packaging and labeling operations and label control
Laboratory control	Lab procedures, testing, method validation, stability and data integrity

Inspection depth depends on risk. “The full inspection option should include an inspection of at least four systems, one of which must be the quality system,” while the abbreviated option covers “two to three systems, one of which must be the quality system” (FDA). If “one or more systems are documented as not in a state of control,” the inspection can be classified Official Action Indicated (OAI).

The quality system is always in scope. Make it your strongest.

What investigators find most

An analysis of FY2025 Form 483 data shows where drug sites fall short (GMP Insiders):

System	Top citation	FY2025 observations
Quality	211.22(d) quality unit procedures not written or followed	243
Quality	211.192 investigations	164
Production	211.100(a) written production procedures	162
Laboratory	211.160(b) laboratory controls not scientifically sound	121
Facilities and equipment	211.67(a) equipment cleaning and maintenance	95
Laboratory / data	211.68(b) computerized system controls	87

A February 2026 warning letter shows how these combine. FDA cited a firm for failing to test each batch for objectionable microorganisms under 211.165(b), for failing “to establish adequate written responsibilities and procedures applicable to the quality control unit” under 211.22(d), and noted an out-of-trend result found among discarded materials that “was neither properly documented at the time of performance nor adequately investigated” (FDA warning letter, Nelson Co.).

Staying GMP compliant between inspections

Run your own six-system review at least yearly, quality system first.
Compare procedures with practice on the floor and in the lab; fix whichever is wrong.
Trend deviations, OOS results and complaints and check that investigations reach root cause.
Verify data integrity in lab and production systems, including audit trail review.
Hold management review of quality metrics, with resources assigned to gaps.
Audit suppliers and contract sites to the same standard.
Keep an inspection-ready file: site master information, organization charts, product lists, recent deviations and CAPAs.

During and after an inspection

Escort investigators, answer accurately and provide requested documents promptly.
Keep a record of every request and every document provided.
Correct simple issues during the inspection when possible, and document the correction.
Respond to any Form 483 in writing within 15 business days, the window FDA uses to consider a response before deciding on further action, with root cause, correction, CAPA and evidence.

GMP compliance and inspection readiness checklist

Find compliance gaps before the investigator does

AskDona reviews SOPs, investigations, batch records and lab records against 21 CFR 211, ICH Q7 or your own procedures, organizes findings by the six FDA systems, flags gaps and contradictions, and cites the passage behind every finding.

Run a sample GMP compliance assessment on one system’s procedures and records. AskDona shows the evidence; your quality unit decides.

FAQ

What is GMP compliance? Meeting current good manufacturing practice rules, such as 21 CFR 210 and 211, in every batch and every record.

What does an FDA GMP inspection cover? Up to six systems: quality, facilities and equipment, materials, production, packaging and labeling, and laboratory control (FDA).

What is the difference between a full and abbreviated inspection? A full inspection covers at least four systems; an abbreviated one covers two or three. Both always include the quality system.

What is OAI? Official Action Indicated, a classification that can lead to a warning letter or other regulatory action.

Can FDA inspect without notice? Yes. FDA expanded unannounced foreign inspections in May 2025 (Hogan Lovells).

References

All pages opened and checked by October 14, 2026.

Source	Type	Date	Used for
FDA: Facts about CGMP	Regulator	Nov 21, 2025	Adulteration
FDA: Compliance program 7356.002F (API)	Regulator	Aug 1, 2025	Six systems, inspection options
GMP Insiders: FY2025 observations	Trade analysis	Jan 5, 2026	Citation counts
FDA warning letter: Nelson Co.	Regulator	Feb 12, 2026	Example findings
Hogan Lovells: Unannounced foreign inspections	Law firm	May 8, 2025	Inspection policy