What has FDA cited under WHO-PQ?

1 DSRV article cite WHO-PQ. Enforcement cases behind them: NAFDAC 5+5 Policy results published March 2026: 191 applications, 185 approved, 108 facility layouts cleared, 20 completed, 88 under construction. 58% first-time manufacturers. Inspection exposure across them: 1 high.

What does DSRV recommend for WHO-PQ?

From the newest article (108 New Drug Facilities in Nigeria. Most Have Never Been Inspected.): NAFDAC approval confirms a facility was built. It does not confirm the quality system inside it is ready for WHO-PQ or FDA scrutiny. The 63 first-time manufacturers entering Nigeria's supply chain carry inspection risk proportional to their lack of prior GMP testing. DSRV is decision support, not legal advice; verify against the official source each article names.

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WHO-PQ

Every DSRV article whose Regulatory Snapshot cites WHO-PQ: the enforcement case behind it, the inspection exposure it created, and what the desk would do about it.

Inspection exposure across the set

What has FDA cited under WHO-PQ?: 1 DSRV article cite WHO-PQ. Enforcement cases behind them: NAFDAC 5+5 Policy results published March 2026: 191 applications, 185 approved, 108 facility layouts cleared, 20 completed, 88 under construction. 58% first-time manufacturers. Inspection exposure across them: 1 high.
What does DSRV recommend for WHO-PQ?: From the newest article (108 New Drug Facilities in Nigeria. Most Have Never Been Inspected.): NAFDAC approval confirms a facility was built. It does not confirm the quality system inside it is ready for WHO-PQ or FDA scrutiny. The 63 first-time manufacturers entering Nigeria's supply chain carry inspection risk proportional to their lack of prior GMP testing. DSRV is decision support, not legal advice; verify against the official source each article names.

June 20266 min readHigh exposurecited as a tag
108 New Drug Facilities in Nigeria. Most Have Never Been Inspected.
NAFDAC's 5+5 Policy approved 108 new pharmaceutical manufacturing sites by early 2026. Sixty-three of them are first-time manufacturers with no inspection history, entering a supply chain where WHO prequalification assessments will test what local approval did not.
Case
NAFDAC 5+5 Policy results published March 2026: 191 applications, 185 approved, 108 facility layouts cleared, 20 completed, 88 under construction. 58% first-time manufacturers.
DSRV take
NAFDAC approval confirms a facility was built. It does not confirm the quality system inside it is ready for WHO-PQ or FDA scrutiny. The 63 first-time manufacturers entering Nigeria's supply chain carry inspection risk proportional to their lack of prior GMP testing.

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Pressure-test your evidence before an inspector reads it

Bring the document that has to hold up under WHO-PQ. DSRV maps the evidence, names the gaps, and routes judgment calls to human review. Controlled intake, no public file upload.

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Regulatory intelligence and interpretation, not legal advice. Verify against the official FDA or ICH source each article names.