DIETARY SUPPLEMENT DOCUMENTATION SELF-ASSESSMENT CLIENT _______________________________ DATE ________________

SOP Type/Section SOPs Criticality * Present

Equipment Cleaning (and Logs) Equipment 1 B YES NO

Calibration SOPs for Mfg Equipment (and Logs) Equipment 1 B YES NO

Validation of Equipment and Processes Equipment 1 A YES NO

Utilities (Water, Air) Facilities 1 C YES NO

Distribution Holding & Distribution 1 B YES NO

Product Disposition (and Logs) Holding & Distribution

Sampling and Handling for Lab Testing (and Logs) Laboratory Controls 1 B YES NO

Bioburden Sampling and Handling (and Logs) Laboratory Controls

Stability Program Laboratory Controls 1 B YES NO

Labels and Promotional Materials - Control & Approvals (and Docs)

Packaging and Labeling Control

1 A YES NO

Packaging Development and Approvals (and Forms) Packaging and Labeling Control

Manufacturing Methods (and Batch Records) Production and Process Controls 1 A YES NO

Acceptance Production and Process Controls 1 A YES NO

Nonconforming Product Production and Process Controls 1 A YES NO

Facility Cleaning Procedures (and Logs) Production and Process Controls 1 A YES NO

Environmental Monitoring (and Logs) Production and Process Controls 1 B YES NO

Specifications Development Production and Process Controls 1 C YES NO

Audits & Inspections (and Form) Stand-alone 1 A YES NO

Management Responsibilities (and Minutes Template)

Stand-alone 1 A YES NO

Personnel Training and Sanitation (and Logs) Stand-alone 1 A YES NO

Complaint Management (and Spreadsheet) Stand-alone 1 A YES NO

DIETARY SUPPLEMENT DOCUMENTATION SELF-ASSESSMENT CLIENT _______________________________ DATE ________________

SOP Type/Section SOPs Criticality * Present

Corrective and Preventive Action (and Spreadsheet) Stand-alone 1 A YES NO

Corrections and Removals (Recalls) Stand-alone 1 B YES NO

Computer Related Systems Stand-alone 1 C YES NO

HACCP Procedure (and Forms) Stand-alone 1 A YES NO

Quality Agreements (and Template) Supplier

1 A YES NO

Supplier Management Supplier

Contractor Management Supplier

Quality manual Tier 1 1 A YES NO

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*Criticality

A = Highest Prioirity - needed prior to production initiation

B = Moderate Priority - needed before first batch delivered

C = Lower Priority - May be developed within 60 days of production initiation