Michael Sassano: GMP Series #8: Manufacturing Startup

Authored By: Michael Sassano and Antonio Guedelha

Your journey maneuvering through the start-up phase of Good Manufacturing Practices (GMP) will finish with certification of your building, processes and ramping up your manufacturing. Finally. All of the preparation and work that went into selecting, designing & building your facility, including choosing & installing your equipment, setting up your laboratory, Enterprise Resource Planning (ERP), making your Quality Assurance Plans and staffing your facility will be tested by regulators before you can start operations. Be confident you have made all the right choices along the way — it’s time to prove it. Once you ask the regulators to come for an inspection, there is no going back. 

Planning is Critical to GMP Certification

The start-up of the facility needs planning, organization and preparation. Even if you have all the resources, take this time to define the route and drive toward recovering the investment. At this point, products to start running the facility are defined as well as the manufacturing methods and laboratory analysis methods. You should also have a batch manufacturing plan in place for the batches to be produced before inspection and after GMP approval. By now, you’ll also have your team in place. Be sure each member of your team has a defined role and means to keep the flow of information on course.

Perform Trial Runs Before Inspection

Before your inspection, spend a minimum of 2 or 3 months operating the equipment and executing trial runs and full production. Ensure these mock trials are performed with staff according to GMP standards. During this step, manufacture at least 3 batches of each product which will define the facility approval by the product family. This step is particularly important in the European Union as it is required for EU GMP certification. After successful production of these batches, have your team create the Process Validation Report of the product under QA supervision. This is needed to present the regulators with real data to approve your Facility.

A month or two before you feel you will be ready, request the regulators come and inspect your facility. You need to send them the Site Master File, your list of Standard Operating Procedures (SOPs), Quality Assurance Manual, layout of the facility and the Facility Industrial Operation license. Once your materials are received, the regulators will analyze the documents and contact you for inspection. It’s important that you are ready by the time they arrive, and it is good practice to contact the regulators in advance because it takes several weeks for them to come. 

Prepare for Inspection

Before the inspectors come, prepare for the inspection. Check that all of your records are filled out, signed and dated. Check in on your reports for errors. File all documentation in an organized way near the room where you will receive the inspectors. Often, they will write in the report that you couldn’t show the document if you take too much time to produce it. This will also avoid the time needed to make changes in the documents on the spot.

The first visit with the regulators will usually last a few days, and they will want to see and challenge everything from your building construction to your flows, equipment and each aspect of your Quality Assurance Plan. They will visit all rooms of the facility, ask for documentation, reports, validation, qualification, calibration and other main Quality Assurance system SOPs. After the first visit, they will usually have corrective actions that will be required. Some can be major, but often there will be many minor issues to correct. Be prepared to solve non-conformities during the inspection if possible, or during the night before their next visit. The Inspector will write the non-conformity but can adjust if it is resolved on the spot. Solving the issue is what GMP is about and demonstrates your professionalism.

Remedy Necessary Issues

Upon receiving the initial report, you will have a set time to remedy and appropriately address corrections to your facility and processes. Depending on the severity and amount of corrections, as well as your ability to address them will depend on how many more visits and correction periods occur before you are certified. The goal is to pass the first inspection, so prepare your staff well and double-check each document, record, facility, equipment maintenance and cleaning protocol. If you are so inclined, you can also ask a consulting company to inspect the facility before the inspectors and take action to correct all issues before the regulators pay a visit.

Furthermore, for certain controlled manufacturing substances like cannabis as a narcotic, you will need police or local authority authorization for your security plan. You may also need your pharmaceutical manufacturing authorization from the local authorities in addition to all the local requirements. Once you receive your Facility Industrial Operation license and GMP authorizations, you are ready to start your operations. During startup, focus your attention on production for the market and organizing the operation. Facilitate regular meetings with staff and begin defining important regular reports, on a weekly and monthly basis. These reports of the ERP are critical for the optimization and management of the total operation.

This is Only the Beginning

Although the road to begin operating a GMP facility is complete, this isn’t the end. This is nothing more than a technical end to our start-up series. We will be adding more series on tackling issues within your facility and growing your company with GMP compliance. We hope you enjoyed and found this informative. There is so much more to come and although this journey has ended, another is about to begin. 

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Author Bios

Matt Maurer – Minden Gross
Jeff Hergot – Wildboer Dellelce LLP

Costa Rica
Tim Morales – The Cannabis Industry Association Costa Rica

Elvin Rodríguez Fabilena


Julie Godard
Carl L Rowley -Thompson Coburn LLP

Jerry Chesler – Chesler Consulting

Ian Stewart – Wilson Elser Moskowitz Edelman & Dicker LLP
Otis Felder – Wilson Elser Moskowitz Edelman & Dicker LLP
Lance Rogers – Greenspoon Marder – San Diego
Jessica McElfresh -McElfresh Law – San Diego
Tracy Gallegos – Partner – Fox Rothschild

Adam Detsky – Knight Nicastro
Dave Rodman – Dave Rodman Law Group
Peter Fendel – CMR Real Estate Network
Nate Reed – CMR Real Estate Network

Matthew Ginder – Greenspoon Marder
David C. Kotler – Cohen Kotler

William Bogot – Fox Rothschild

Valerio Romano, Attorney – VGR Law Firm, PC

Neal Gidvani – Snr Assoc: Greenspoon Marder
Phillip Silvestri – Snr Assoc: Greenspoon Marder

Tracy Gallegos – Associate Fox Rothschild

New Jersey

Matthew G. Miller – MG Miller Intellectual Property Law LLC
Daniel T. McKillop – Scarinci Hollenbeck, LLC

New York
Gregory J. Ryan, Esq. Tesser, Ryan & Rochman, LLP
Tim Nolen Tesser, Ryan & Rochman, LLP
Cadwalader, Wickersham & Taft LLP

Paul Loney & Kristie Cromwell – Loney Law Group
William Stewart – Half Baked Labs

Andrew B. Sacks – Managing Partner Sacks Weston Diamond
William Roark – Principal Hamburg, Rubin, Mullin, Maxwell & Lupin
Joshua Horn – Partner Fox Rothschild

Washington DC
Teddy Eynon – Partner Fox Rothschild