The Ultimate Oral Solid Dose Audit Tool

Comprehensive Oral Solid Dose (OSD) Audit Checklist

I spent 14 years as an FDA Investigator and issued more Form FDA-483s than I care to count. For the 13 years afterwards including part of the team that navigated J&J out of consent decree, I was directly responsible for FDA-483s received.

Most OSD audit checklists ask whether a control exists. This one tells you how to verify it's actually working and what an Investigator finds when it isn't, because those are the same findings I documented from the other side of the table for 14 years.

This is a working audit tool, not a theory document. Bring it into the plant.

[This is an employer-reimbursable professional compliance resource. Send this page to your Quality Director, Site Head, Regulatory Affairs leader or Learning and Development department for approval.]

What's inside (65 audit items across 12 GMP domains):

• GMP Documentation Control, including Master Batch Record compliance with 21 CFR 211.186 and NDA/ANDA consistency checks
• Training program adequacy, from curriculum documentation through demonstrated competency
• Manufacturing Process Controls, covering granulation, blending, blend uniformity, tablet compression, and capsule filling
• Purified Water systems, including USP compliance, dead leg identification, sanitization, and use-point testing
• Finished Product Testing, including analytical method validation (ICH Q2), OOS investigation, and HPLC qualification
• Stability programs under 21 CFR 211.166, forced degradation studies, and stability-indicating method confirmation
• Facility Cleanliness, with specific attention to dust accumulation and cross-contamination risk
• Environmental Monitoring, including differential pressure control between classified areas
• Equipment Qualification (IQ/OQ/PQ), calibration, and preventive maintenance
• Data Integrity, including audit trail review and access control management
• Deviations, Investigations, and CAPA effectiveness
• Process Validation, including the consecutive-run requirement

Every single item includes:

• A plain-language description of the GMP expectation
• How to Verify: the specific records, walkthroughs, and interviews to conduct on-site
• Common Deficiencies: the actual findings Investigators cite most often for that item
• A Yes / No / N/A compliance field and space for auditor comments

Plus dedicated sections for Objectionable Observations and Recommendations & Follow-Up Actions, so the completed audit functions as a standalone report.

Aligned to 21 CFR Part 211 and ICH Q10.

Who this is for: Internal audit teams and QA professionals conducting OSD facility assessments, consultants preparing clients for FDA inspection, and quality leaders who need a defensible audit record, not a generic form.