FDA 21 CFR Part 820 Quality System Regulation

FDA 21 CFR Part 820 Quality System Regulation:

FDA 21 CFR Part 820 Quality System Regulation: Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

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Table of contents

Subpart A - General Provisions

820.1 Scope.

820.3 Definitions.

820.5 Quality system.

Subpart B - Quality System Requirements

820.20 Management responsibility.

820.22 Quality audit.

820.25 Personnel.

Subpart C - Design Controls

820.30 Design controls.

Subpart D - Document Controls

820.40 Document controls.

Subpart E - Purchasing Controls

820.50 Purchasing controls.

Subpart F - Identification and Traceability

820.60 Identification.

820.65 Traceability.

Subpart G - Production and Process Controls

820.70 Production and process controls.

820.72 Inspection, measuring, and test equipment.

820.75 Process validation.

Subpart H - Acceptance Activities

820.80 Receiving, in-process, and finished device acceptance.

820.86 Acceptance status.

Subpart I - Nonconforming Product

820.90 Nonconforming product.

Subpart J - Corrective and Preventive Action

820.100 Corrective and preventive action.

Subpart K - Labeling and Packaging Control

820.120 Device labeling.

820.130 Device packaging.

Subpart L - Handling, Storage, Distribution, and Installation

820.140 Handling.

820.150 Storage.

820.160 Distribution.

820.170 Installation.

Subpart M - Records

820.180 General requirements.

820.181 Device master record.

820.184 Device history record.

820.186 Quality system record.

820.198 Complaint files.

Subpart N - Servicing

820.200 Servicing.

Subpart O - Statistical Techniques

820.250 Statistical techniques.

FDA 21 CFR Part 820 Quality System Regulation:

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