Description: Knowledge, skills and abilities needed to complete a cGMP inspection.

Terminal Competency:

Confirm the scope of the inspection.

Enabling Competencies:

1. Review facility history.

2. Determine what parts of 21 CFR 117 are applicable.

3. Construct a process flow diagram.

4. Write a process flow narrative.

5. Verify firm processes.

6. Explain exemptions to the regulation.

7. Develop inspectional approach.

8. Recognize compliance vs. non-compliance.

9. Determine the criticality of cGMP violations.

To see a set of behavioral anchors, which provide further detail about the enabling competencies and can be used for assessment against the enabling competencies, contact IFPTI.

Description: Knowledge and skills related to evaluating compliance with 21 CFR 117 Subparts A (General Provisions) and F (Requirements Applying to Records That Must Be Established and Maintained) during a cGMP inspection.

Terminal Competency:

Evaluate compliance with training requirements.

Enabling Competencies:

1. Compare training received with requirements of applicable Subparts of 21 CFR 117.

2. Compare training received with individual job responsibilities.

3. Determine 21 CFR 117 Subpart F recordkeeping compliance.

To see a set of behavioral anchors, which provide further detail about the enabling competencies and can be used for assessment against the enabling competencies, contact IFPTI.

Description: Knowledge and application of 21 CFR 117 Subpart B requirements during a cGMP inspection.

Terminal Competency:

Evaluate compliance with cGMPs.

Enabling Competencies:

1. Inspect against 21 CFR Subpart B section 117.10: Personnel.

2. Inspect against 21 CFR Subpart B section 117.20: Plant and grounds.

3. Inspect against 21 CFR Subpart B section 117.35: Sanitary operations.

4. Inspect against 21 CFR Subpart B section 117.37: Sanitary facilities and controls.

5. Inspect against 21 CFR Subpart B section 117.40: Equipment and utensils.

6. Inspect against 21 CFR Subpart B section 117.80: Processes and controls.

7. Inspect against 21 CFR Subpart B section 117.93: Warehousing and distribution.

8. Inspect against 21 CFR Subpart B section 117.95: Holding and distribution of human food by-products for use as animal foods.

9. Recognize adulterated food in the context of 21 CFR Subpart B section 117.110: Defect action levels.

To see a set of behavioral anchors, which provide further detail about the enabling competencies and can be used for assessment against the enabling competencies, contact IFPTI.

Description: Knowledge and skills related to evaluating compliance with 21 CFR 117 Subpart D during a cGMP inspection.

Terminal Competency:

Evaluate compliance with applicable Subparts of 21 CFR 117.

Enabling Competencies:

1. Inspect against 21 CFR Subpart D section 117.201: Modified requirements that apply to a qualified facility.

2. Inspect against 21 CFR Subpart D section 117.206: Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food.

3. Recognize when 21 CFR 117 Subpart E: Withdrawal of Qualified Facility Exemption may apply.

4. Determine 21 CFR 117 Subpart D and F recordkeeping compliance.

To see a set of behavioral anchors, which provide further detail about the enabling competencies and can be used for assessment against the enabling competencies, contact IFPTI.

Description: Preparation of final report.

Terminal Competency:

Submit final report

Enabling Competencies:

1. Select agency regulatory forms.

2. Select records for inspection report.

3. Compile evidence.

4. Write inspectional observations.

5. Comply with agency document control procedures.

To see a set of behavioral anchors, which provide further detail about the enabling competencies and can be used for assessment against the enabling competencies, contact IFPTI.