Description: Preparation for a dietary supplement inspection.

Terminal Competency:

Prepare for an inspection of a dietary supplement firm.

Enabling Competencies:

1. Determine the scope of the inspection.

2. Research products/ingredients for issues.

3. Determine the applicability.

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: Ensuring that the firm has required written procedures and required records.

Terminal Competency:

Evaluate written procedures and records of a dietary supplement firm.

Enabling Competencies:

1. Review written procedures.

2. Review records.

3. Explain record requirements.

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: Established specifications and ensuring that testing is conducted in accordance with 21 CFR 111.75.

Terminal Competency:

Evaluate specifications and testing within a dietary supplement firm.

Enabling Competencies:

1. Ensure that the firm has established identity specifications.

2. Ensure that the firm has established component specifications.

3. Ensure that the firm has established limits on contamination that may adulterate finished product.

4. Ensure that in-process specifications are established.

5. Ensure that finished product meets established specifications.

6. Ensure that packaging/labeling of dietary supplements meets specifications.

7. Ensure that appropriate testing is conducted to meet specifications.

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: Requirements related to MMRs and BPRs.

Terminal Competency:

Evaluate production and process controls within a dietary supplement firm.

Enabling Competencies:

1. Ensure that there are written MMRs.

2. Review the MMRs for required elements.

3. Ensure that the firm prepares batch production records.

4. Review the BPRs for required elements.

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: Finished product labels and labeling.

Terminal Competency:

Evaluate dietary supplement labels/labeling.

Enabling Competencies:

1. Identify claims that could appear on a label/labeling.

2. Determine if the product is a dietary supplement.

3. Review the label/labeling for drug claims.

4. Review supplement facts.

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: Ensuring the implementation of QC operation systems.

Terminal Competency:

Evaluate quality control operations within a dietary supplement firm.

Enabling Competencies:

1. Assess quality control operations. (Subpart F)

2. Ensure that QC is approving/rejecting. (Subpart F)

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: Requirements related to laboratory operations.

Terminal Competency:

Evaluate laboratory operations within a dietary supplement firm.

Enabling Competencies:

1. Ensure the laboratory facilities are adequate.

2. Ensure laboratory control processes are followed. (Subpart J)

3. Ensure test methods/examinations are within established specifications.

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: Requirements relating to the holding and distribution of dietary supplements.

Terminal Competency:

Evaluate holding and distribution related to dietary supplement products.

Enabling Competencies:

1. Ensure that the firm holds components and finished products under appropriate conditions so that the identity, purity, strength, and composition of the components and dietary supplements are not effected.

2. Ensure that the firm holds packaging and labeling materials under appropriate conditions.

3. Ensure in-process materials are held under appropriate conditions.

4. Ensure that the reserve samples are held under appropriate conditions.

5. Ensure that the product is protected during distribution.

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: Requirements relating to the return of dietary supplement products.

Terminal Competency:

Evaluate returned dietary supplement products.

Enabling Competencies:

1. Ensure that returned product is handled appropriately.

2. Ensure that any reprocessed product meets all established specifications.

3. Ensure investigation of additional batches if returned product implicates other batches.

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: Complaints related to dietary supplements.

Terminal Competency:

Evaluate complaints related to dietary supplements.

Enabling Competencies:

1. Review complaints.

2. Ensure investigation of any product complaint.

3. Ensure quality control reviews/approves decisions.

4. Review adverse events. (Preamble)

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.