GMP Equipment Documentation & Template Package
Get set up with GMP
Ensure your equipment is ready for GMP certification with our GMP Equipment Documentation & Template Package. With this you will receive everything you need to ensure that your machine is GMP compliant such as:
- Certificates for materials in product contact surfaces.
- Electrical point to point schematics.
- And PLC Logic Schematics.
Many years of direct experience has allowed United Science to assemble this comprehensive set of detailed documents that may be used as templates to assist those who desire to have GMP compliance on specific equipment. Included in this package are hundreds of pages of valuable documents and easy to use templates that will assist you in meeting cGMP and/or euGMP requirements associated with audits and inspection.
Having a GMP certification means you stand for quality.
By following Good Manufacturing Practices you are ensuring your business is on the path to success. Having quality machine schematics, good maintenance manuals, and a critical spare parts list makes sure that you know how to maintain your equipment to operate at high levels for a long time. Not to mention that maintenance time should be minimized because of these exact documentations.
Watch our extrakTALKS recording on the ‘Top 5 Reasons to be EU GMP’
What Our GMP Equipment Documentation & Template Package Gives You
- Packing list
- Operation, Maintenance Manuals.
- Certificates for materials in product contact surfaces. (3-4weeks)
- Equipment Schematics
- Electrical point to point schematics
- Electrical panel schematics
- Critical Spare Parts List
- Buy component cut sheets
- Utilities needed to operate the equipment
- Installation Drawings
- Manufacturer Generated URS
- Listing of instruments that are part of the piece of equipment.
- Calibration certificates for all instruments. (3-4 weeks)
- FAT Test Results and Procedures
- SAT Test Procedures
- Control Schematics
- PLC Logic Schematics
- Control Panel Logic
- Top Level P&ID
- Top Level Assembly Drawings
- Alarms with limits and default settings
Frequently Asked Questions
If You are Based in the US and Want to Sell Hemp Products to the EU do You have to be EUGMP Certified?
Yes. While similar, your facility will need certification in both US and EUGMP 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.
Is This a Federal Law or State Law? Do States Force You To Use it?
Any manufacturer of food or active substances is required by law to adhere to GMP standards.
In the United States, GMP standards are enforced by the FDA. This can be monitored through regular facility inspections that ensure a manufacturer is complying with cGMP standards during production.
Serious violations of those standards, can result in product recall or other serious repercussions that could severely impact the manufacturer in terms of profit loss and operations.
Why do cGMP and EUGMP Regulations Matter?
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 EUGMP 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.
What Are the Differences Between EUGMP & CGMP?
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.
What is cGMP & EUGMP?
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.