gmp complianT downloadable worksheets, templates, and forms

We’ve gone through 21 CFR 111, Good Manufacturing Practices for Dietary Supplements, and broken the regulation down into digestible walk-throughs and worksheets. Anne offers a free initial consultation for those who don’t know where to begin, or are seeking guidance on which worksheets and guides to purchase. Alternatively, you can purchase the entire package of 34 templates, forms, and sample documents.

shop downloads

Includes all 34 templates, forms, and sample documents.

Covers requirements for personnel.

  • SOP Personnel Health and Hygiene

  • SOP Personnel Qualifications

  • Personnel Training Form

Personnel (21 cfr 111 subpart B)
$15.00
Physical Plant (21 cfr 111 subpart C)
$15.00

Covers cleaning of the physical plant including both interior, exterior, and pest control.

  • SOP Facility Cleaning and Pest Control

  • Interior Cleaning Form

  • Exterior Cleaning Form

Equipment (21 cfr 111 subpart D)
$20.00

Covers equipment and utensil cleaning and calibration of measuring equipment.

  • SOP Equipment Cleaning

  • SOP Equipment Calibration

  • Sample Scale Calibration Form*

  • Sample Thermometer Calibration Form*

    *Designed for very small companies

Production and Process Control (21 cfr 111 subpart E)
$20.00

Covers the requirement for specifications throughout the manufacturing process including instances where specifications are not met.

  • SOP Nonconforming Material

  • Nonconforming Material Form

  • Specification Rationale Form

  • Finished Dietary Supplement Specification

Quality Control (21 cfr 111 subpart F)
$15.00

Covers the role of Quality control in the entire GMP regulation.

  • SOP Quality Control Requirements

Receiving (21 cfr 111 subpart G)
$20.00

Covers the procurement of components, materials, and ingredients. For very small herbal companies, this may include growing and/or foraging your components.

  • SOP Receiving Purchased Components

  • SOP Harvesting of Plants

  • Harvested Raw Material and Processing Record

  • Purchased Dietary Ingredient Spec

Coming soon! SOP Supplier Approval and Monitoring and Records

Master MFG Record (21 cfr 111 subpart H)
$20.00

The Master Manufacturing Record (MMR) details the steps manufacture a finished dietary supplement and ensures a consistent product from batch to batch.

  • SOP MMR Template

  • Sample MMR for Simple Alcohol Extraction

Production Batch Record (21 cfr 111 subpart I)
$15.00

The Production Batch Record provides proof that your batch of dietary supplement was manufactured to the requirements listed in your Master Manufacturing Record.

  • Sample Alcohol Extraction Batch Record

  • Sample Alcohol Extraction Manufacturing Process

Laboratory Ops (21 cfr 111 subpart J)
$15.00

Covers inspection and testing laboratory requirements. For small manufacturers, any sophisticated chemical or genetic testing will be sent to a 3rd party testing facility.

  • SOP Testing and Inspection Requirements

Manufacturing Ops (21 cfr 111 subpart K)
$15.00

Covers requirements of manufacturing processes including design, sanitation, and contamination.

  • SOP Manufacturing Operations Requirements

Packaging and Labeling (21 cfr 111 subpart L)
$15.00

Covers requirements for packaging and labeling materials. This does NOT include label contents.

  • SOP Packaging and Labeling Operations Requirements

Holding and Distribution (21 cfr 111 subpart M)
$15.00

Covers requirements for holding of materials, components, in-process, and finished products and the distribution of finished products.

  • SOP Holding and Distribution

  • Shipping and Distribution Form

Returned Product (21 cfr 111 subpart N)
$15.00

Covers product returns and how that product is identified, handled, and dispositioned upon receipt.

  • SOP Returned Product

  • Return Material Authorization Form

Product Complaints (21 cfr 111 subpart O)
$15.00
Good Manufacturing Practices for Dietary Supplements - Complete Set
$200.00

Covers the review and investigation of product complaints to determine their validity and implications for other products.

  • SOP Product Complaints

  • Customer Feedback Form

Cover requirements for records generated in the production of dietary supplements and their retention.

  • SOP Record Requirements

Records (21 cfr 111 subpart P)
$15.00