FDA Regulation – CFRs

Food, Drug and Cosmetic Act, Section 351, Adulterated Drugs and Devices

21 CFR Part 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding Of Drugs; General

21 CFR Part 211 – Current Good Manufacturing Practice For Finished Pharmaceuticals

21 CFR Part 820 – Quality System Regulation - Medical Devices

FDA Guidances

Data Integrity and Compliance with cGMP

Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept for Operations

Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance

Product Identifier Requirements Under the Drug Supply Chain Security Act - Compliance Policy (draft guidance)

Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection

Medical Device Reporting for Manufacturers – Final Guidance

Current Good Manufacturing Practice for Phase 1 Investigational Drugs

A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients

Guideline for Preparation of Investigational New Drug Products

Current Good Manufacturing Practices for Medical Gases (2017 Draft)

Compressed Medical Gases Guideline

Quality Systems Approach to Pharmaceutical CGMP Regulations

The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice

Testing of Glycerin for Diethylene Glycol

Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting

Pharmaceutical Components at Risk for Melamine Contamination

Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice

Process Validation: General Principles and Practices

Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment

Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron

Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide

Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

PET Drugs — Current Good Manufacturing Practice (CGMP)


MaPP 5014.1 – Understanding CDER’s Risk-Based Site Selection Model NEW!

Investigations Operations Manual 2018

Inspection of Medical Device Manufacturers

Regulatory Procedures Manual