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. Each purchase comes with an optional, 30 minute one-on-one consultation with our GMP Expert, Anne Weiland. Instruction for how to book your free consultation will be included with each download. Anne also 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.

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Covers requirements for personnel.

  • SOP Personnel Health and Hygiene

  • SOP Personnel Qualifications

  • Personnel Training Form

Personnel (21 cfr 111 subpart B)
$225.00
Physical Plant (21 cfr 111 subpart C)
$175.00

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)
$300.00

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)
$300.00

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)
$100.00

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

  • SOP Quality Control Requirements

Receiving (21 cfr 111 subpart G)
$325.00

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)
$200.00

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)
$200.00

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)
$100.00

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)
$100.00

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

  • SOP Manufacturing Operations Requirements

Packaging and Labeling (21 cfr 111 subpart L)
$100.00

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)
$150.00

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)
$150.00

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)
$150.00

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)
$100.00