Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. General
  6. Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community
  7. Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices

Checkout our iOS App for a better way to browser and research.

Section
26.1

Definitions.

Section
26.2

Purpose.

Section
26.3

Scope.

Section
26.4

Product coverage.

Section
26.5

Length of transition period.

Section
26.6

Equivalence assessment.

Appendix
Appendix A to Subpart A of Part 26

List of Applicable Laws, Regulations, and Administrative Provisions

Appendix
Appendix B to Subpart A of Part 26

List of Authorities

Appendix
Appendix C to Subpart A of Part 26

Indicative List of Products Covered by Subpart A

Appendix
Appendix D to Subpart A of Part 26

Criteria for Assessing Equivalence for Post- and Preapproval

Appendix
Appendix E to Subpart A of Part 26

Elements To Be Considered in Developing a Two-Way Alert System

Section
26.7

Participation in the equivalence assessment and determination.

Section
26.8

Other transition activities.

Section
26.9

Equivalence determination.

Section
26.10

Regulatory authorities not listed as currently equivalent.

Section
26.11

Start of operational period.

Section
26.12

Nature of recognition of inspection reports.

Section
26.13

Transmission of postapproval inspection reports.

Section
26.14

Transmission of preapproval inspection reports.

Section
26.15

Monitoring continued equivalence.

Section
26.16

Suspension.

Section
26.17

Role and composition of the Joint Sectoral Committee.

Section
26.18

Regulatory collaboration.

Section
26.19

Information relating to quality aspects.

Section
26.20

Alert system.

Section
26.21

Safeguard clause.