GMP Equipment Documentation

This is a documentation package to ensure receipt and proper installation of the appropriate parts and systems of the process equipment. Many years of direct experience has allowed United Science to assemble this comprehensive set of detailed documents. These can be used as templates to assist those who desire to have GMP compliance on specified equipment. Included in this package are hundreds of pages of valuable documents and easy to use templates to assist you in meeting cGMP and/or euGMP requirements associated with audits and inspection.

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Whether you are building from scratch or retrofitting an existing building to meet your manufacturing and packaging needs, our expert designers will help you develop your ideal botanical extraction lab.

Deliverables Included

  • Component Cut Sheet
  • Required Utilities for Equipment Operation
  • Installation Drawings
  • Manufacturer Generated URS
  • Control Panel Logic
  • Top Level P&ID
  • Top Level Assembly Drawings
  • Alarms with Limits & Default Settings

Included Certificates

  • Product Contact Surface Material Certificates
  • Instrument Calibration Certificates

Provided Schematics

  • Equipment & Electrical Point to Point
  • Electrical Panel
  • Control & PLC Logic

Material Certification Documentation Includes:

  • Wetted Surfaces
  • Certified Gauges
  • Calibration Certifications for extractor quality processes

Lists & Manuals

  • Packing List
  • Operation & Maintenance Manuals
  • Critical Spare Parts List
  • Equipment Instrument List
GMP Equipment Documentation Brochure

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Additional Terms

  1. Additional requested items will be charge to the customer at $2K USD per item.
  2. All documentation is supplied in PDF format and is United Science confidential for one time use for the specified equipment.
  3. When applicable, component manuals will be provided to the customer.
  4. c/euGMP certification package must be specified prior to equipment purchase.
  5. This GMP package has no implied or express warranty or guarantee of compliance with local, federal, or international regulations.

Frequently Asked Questions

Current Good Manufacturing Practices, or cGMP, is a set of standards defined by the FDA that are intended to ensure acceptable manufacturing processes in regulated industries like pharmaceuticals, food and supplement manufacturing.

These standards can apply to: assurance of raw material quality, testing parameters, standard operating procedures, quality management, identifying and investigating deviations, etc. All of these standards intended to mitigate potential risks of contamination, quality failure or any other impact to potential customer safety.

Essentially the same principle, EUGMP standards are set instead by the European Medicines Agency intended to ensure quality and safety of products in the food and pharmaceutical industries.

From producer to customer, these GMP standards are essential to ensure quality and consumer safety. Without these standards, it would be all too easy for manufacturers to cut or compromise quality practices that are implemented for the end user to receive a good, safe product.

This applies to risk of contamination, mistakes like mislabeling, consistent product contents, etc. Not only could this lead to a product that may be unsafe, it could lead to a product that is essentially ineffective.

Unless you intend to keep your market in your own country, it is important for you to pay attention to (and abide by) both cGMP and EU-GMP standards. The CBD industry is often referred to as the wild west because of its rapid legalization without the standardization to match. While that research is being conducted, producers can confidently create a product that is safe and effective for their customers by adhering to these GMP guidelines.

Though similar, there are a few key differences between cGPM and EUGMP. In both instances, a yearly review of manufacturing practices and product quality is required.

The FDA “Annual Product Review” (APR) is implemented to evaluate the quality standards of each drug product annually and also determines the necessary changes in specifications and operating procedures.

The primary task of the EU ”Product Quality Review” (PQR), however, is to focus primarily on the overall quality and manufacturing system and to show that any manufacturer is consistent in quality control when creating their products.

Yes. While similar, your facility will need certification in both US and EU-GMP standards in order to sell any hemp based products from the United States to Europe.

This can be advantageous overall when entering the markets of other countries as the standards of EUGMP are notably high. This allows for the potential access of a multinational European CBD market as opposed to a singularly American market.

Current Good Manufacturing Practices, or cGMP, is a set of standards defined by the FDA that are intended to ensure acceptable manufacturing processes in regulated industries like pharmaceuticals, food and supplement manufacturing.

These standards can apply to: assurance of raw material quality, testing parameters, standard operating procedures, quality management, identifying and investigating deviations, etc. All of these standards intended to mitigate potential risks of contamination, quality failure or any other impact to potential customer safety.

Essentially the same principle, EUGMP standards are set instead by the European Medicines Agency intended to ensure quality and safety of products in the food and pharmaceutical industries.

Contact Us today

Our team has decades of experience in a variety of industries and is ready to provide advice tailored to your individual needs. Before any formal quotations are sent, we’d be more than happy to have a virtual meeting to discuss your project’s intent.

Step 1: Initial Consultation

Set up a call with us to discuss your project and determine if we’re a good fit for your needs.

Step 2: Discussion

We’ll explore multiple variations to identify the best approach for your product.

Step 3: Action Plan

Receive a detailed action plan, including suggested equipment and processes tailored to your specific application.