EU/US GMP Compliance

09/13/2024

ADVANTAGES of the GMP Cannabis Self-Assessment Workbook:

Once you have completed it one time, send the .pdf to ANY buyer who inquires on your product. It is essentially a COMPREHENSIVE roadmap to the GMP Quality Records you have produced.

Once they review it, be prepared to produce some of the Lot Quality Records you have referenced in the workbook. There are over 100 fields in this workbook; your buyer can ask to see any subset of Quality Records mentioned, or any completed set of records for any lot they desire.

Smart buyer QAPs will ask for complete sets of QRs for the lot just before and the lot just after the lot you have referenced, along with your Lot Tracking Log to prove you aren't just sending them random well-documented lots.

Given the large number of filenames you must enter to complete the GMP Self-Assessment Workbook, there is simply NO WAY to anticipate WHAT a buyer's QA Department might ask for, once provided with this document. Therefore, it is IMPOSSIBLE to fake one's way through the audit process for buyers who have been provided this completed GMP Self-Assessment Workbook. You either have the full-blown Quality Management System or you aren't GMP-compliant. Simple.

Given this, I would have thought this product, priced at just $750, would have taken off more than it has. Perhaps "build it and they will come" was not the best business model to follow. At any rate, it is here now, and here is my GUARANTEE:

If you buy it, complete it, and it DOESN'T SATISFY YOUR BUYER... You get 50% of the purchase price REFUNDED! Just send me the letter wherein they want a physical audit of your facility done in addition. (In-person Compliance Inspections went out the window for two years during COVID, and didn't compromise the intensity of the audits conducted thusly, in the least! Just ask anyone who was inspected by Health Canada during COVID! If your buyer INSISTS on an in-person audit, they likely weren't in operation during COVID and are showing their newness to the industry!)

If you have any questions about how this works, just drop me a message!

Send a message to learn more

09/13/2024

EU-GMP Cannabis Self-Assessment Workbook
Site Master File (SMF) and Quality Manual (QM) Roadmap

This workbook is based on the Pharmaceutical Inspection Cooperation Scheme (PIC/S) document Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (SMF) (PE 008-4). This guide reflects changes necessary to meet the Health Canada Cannabis Act requirements. However, in some cases there were conflicts; Health Canada considers harvest, trimming, drying and storage to be included in cultivation activities; given this, GACP Standards should govern associated activities. In contrast, it is universally accepted within the Global Cannabis Industry that GMP Standards begin at the point where the plant is cut from the root ball. Where these conflicts occur, this document follows the more rigorous of the two Standards: GMPs, or Health Canada GPPs.

Good Manufacturing Practices can be defined as adherence to standards at all stages of the product lifecycle. A good Quality Management System (QMS) is a key element of that and can be summarized as verification of adherence to standards. A QMS is built like a tapestry – quality checks and in-process controls are interwoven into the fabric of the production process. Therefore, redundancy in documenting these controls is to be expected – adequate site security is also a quality feature; quality controls are also safety controls that protect public safety.

Purpose: A Site Master File is a necessary tool in preparing for GMP inspections; it contains specific information about the site's quality management policies and activities governing the processing and quality control of cannabis products. Typically, this information is spread across multiple documents. This guide serves as a roadmap to these diverse documents, identifying where the information resides, and what gaps still need to be filled.

ATTENTION:
The integrity of this document as a global resource depends upon its inviolability. Therefore, do not remove sections from this document – if they do not apply, grey out the rows and write “N/A”, and be prepared to defend these actions to regulatory authorities.

Send a message to learn more

10/03/2023

C-45 WEBINAR ON EXPORTING

C-45 is offering a FREE WEBINAR on the realities of exporting cannabis. While export offers a tantalizing new market for cannabis, MOST of the countries interested in Canadian cannabis require at least GMP compliance. If you don't know what a "Quality Management System (QMS)" is, if you don't have quality controls built-in to your product lifecycle, if you don't have an independent QA reviewer responsible for the site's compliance, you PROBABLY AREN'T GMP compliant, and if you tell your buyers you are and they audit you, you will get black-listed. It's tantamount to claiming you have a PhD when you don't have one.

GMP compliance is a way of ordering your processes and flow such that quality is attained at every stage and this fact is checked, double-checked, then reviewed and signed-off by someone whose job description (i.e., roles and responsibilities) revolves around quality.

That doesn't mean you have to have an experienced full-time Quality Assurance Person on board... I have maintained that a robust, detailed, step-by-step QMS can supply all the in-process controls needed, and the assigned QAP has to know nothing more than to follow the instructions contained therein. This has successfully been proven with multiple SunLeaf QMS clients, who are GMP-compliant by virtue of having adhered to the SOPs assiduously. And in some instances, the GMP-compliance has been implemented in a one-person organization.

I highly recommend those interested in exporting product to attend this webinar and ask questions. I will also be answering questions before and after the webinar, through this page. Be sure to Like it so you stay informed.

For those of you who feel you are close to achieving GMP compliance and want to conduct a gap analysis, the SunLeaf Cannabis GMP-Compliance Self-Assessment Workbook is available. Once completed, this document fulfills the GMP requirement of having a Site Master File (SMF) and a Quality Manual (QM).

Here is the link to register for the C-45 Webinar:

A discussion about some of the realities of the Canadian cannabis export market and the process of taking part within it. As the Canadian market continues to experience price compression, many producers are increasingly looking to markets like Australia, Europe, Israel, and South America. Is this an...

09/11/2023

ANNOUNCEMENT

SunLeaf Consulting, well-known creator of the proven EU-GMP Compliant SunLeaf Quality Management System (a.k.a., the SunLeaf DIY SOP Kit) has just released a DIY GMP Self-Assessment Workbook so companies can see how close they are to the desirable status of "GMP Compliant".

Completing the Workbook accomplishes 4 things:

1. It serves as a Gap Analysis showing exactly what needs to be done to plug gaps in the In-Process Controls so you can rightfully claim the title of "GMP Compliant".

2. It serves as a condensed Site Management File (SMF) and Quality Manual (QM) to address the expected lack of both those necessities in GMP compliance.

3. It prepares you for your Health Canada Inspection, since the Workbook reflects the most rigorous requirements between the GMPs and Canadian GPPs. [Sometimes, a company can be superficially GMP-compliant and not remotely close to HC compliant. For example, GACP Standards during cultivation are acceptable to GMP buyers, but not at all adequate to satisfy HC's demand for Lot-Level Tracking, Running Plant Counts, Destruction Records, Agronomic Input Details (dilution, quantity, date), etc. Similarly, while a nod to Recalls is required for GMP Compliance, it is not adequate to prevent a Major Observation in an HC Inspection. And once again, just 5 Majors during a single HC Inspection and you will likely receive a "Non-Compliant" Rating, which means ALL work/sales stop until you are brought back into compliance.]

4. The Workbook serves as a Roadmap to lay your hands on the right file, quickly, during the stress of an inspection.

NOTE: For this new Intellectual Property, SunLeaf has abandoned the Non-Disclosure Agreement (NDA) that provided marginal protection from theft for its QMS. This time, if you are in possession of an editable version of the Workbook and didn't pay for it, you are in violation of International Copyright Laws and will be prosecuted to the fullest extent of the law, AND reported to Health Canada Cannabis Security. A $200 Whistleblower's Reward will be paid to the first person in an organization to show a bootleg copy is being used by that company.

It's better to just pay the $750. You've been warned.

Because this Workbook serves as a bird's eye-view of a company's compliance, it is expected to become a Global Resource, used internationally by sellers and buyers, inspectors and licencees. It will be the starting point for Vendor Audits, HC/GMP Inspections, buyers assessing sellers, and companies considering sale or merging. By itself, through its use, it will serve to harmonize Cannabis GMP Standards, globally.

Win-win.

DM for more information.

09/02/2023

A good overview of the FDA changes in the U.S.:

The Department of Health and Human Services is recommending a major change in the way the federal government treats ma*****na, but stops short of saying it should be decriminalized under federal law. HHS says ma*****na should no longer be classified as Schedule One, which the law defines as having n...

06/09/2023

I will be releasing a DIY GMP Self-Assessment Checklist in the near future, likely through Amazon. This will be useful for businesses to audit their facility and operations to identify any gaps in their compliance. I will also be offering guidance to rectify any gaps identified.

Stay tuned for more info...

05/18/2023

The 10 Commandments of GMP Compliance:

1. Thou shalt follow a Risk-Based Methodology and document this methodology.
2. Thou shalt have written, approved, Quality Standards, (i.e., SOPs) and thou shalt abide by those Standards til death.
-- Thy Quality Standards shalt be compliant with Industry and Regulatory Mandates.
-- Thy Quality Standards shalt suffer Document Control.
3. Thou shalt produce Quality Records demonstrating adherence to the Standards, and thou shalt retain these QRs according to more Standards.
4. Thou shalt follow Good Documentation Practices (GDP) when completing these records:
-- Thou shalt abide by GDP Law: "If it isn't documented, it didn't happen."
5. Thou shalt have Personnel Standards:
-- Position Descriptions and Qualifications
-- Training required for each position
-- Hygiene & Illness
-- PPE
6. Thou shalt have Facility Standards:
-- Site
-- Security
-- Software
-- Equipment
-- Sanitation
7. Thou shalt have Product Standards:
-- Product Quality Specifications
-- Lot-Level Tracking
-- Work Instructions
-- Internal Lifecycle Controls
-- Final Product Testing to ensure Product Quality Specifications have been met
-- Each Lot must suffer formal Product Release or Rejection
8. Thou shalt Retain Quality Samples to CYA.
9. Thou shalt suffer Internal Audits conducted through Independent Review (QA) of these standards and records:
-- Only the Independent Review may determine Final Product Release or Rejection.
-- Thou shalt have no recourse against this Independent Review; their determination is final.
10. Thou shalt address Deviations From Expected Results:
-- Problem Tracking/CAPA
-- Complaint/Adverse Reaction Reporting
-- Recall Process

(COPYRIGHT 2023, SunLeaf Farmacy, permission granted to reprint in its entirety with proper credit given. Primarily taken from 21 CFR 600, Biological Products)

05/18/2023

Welcome to GMP Compliance for both the EU and the US (they are very similar)!

This page was created to help small-to-medium businesses decide if they want or need to become GMP-compliant, or even become GMP-Certified -- they are 2 different things.

Let me answer a few quick questions:

1. It is inexpensive to become GMP-compliant if you are already utilizing a Quality Management System (QMS).
2. You DO NOT need a consultant to become GMP-compliant.
3. GMP-compliance sets you apart in the industry because few sellers are, and GMP companies are actively seeking suppliers who adhere to GMP Standards.
4. This is because GMP-Certified companies must only use vetted suppliers and being GMP-compliant makes their job of vetting you infinitely easier!
5. Becoming GMP-Certified is only necessary if you wish to sell to the EU or US Medical Markets.
6. The inspection for GMP Certification can only occur AFTER you have a year's worth of Quality Records created while utilizing a QMS.
7. The GMP Inspection is time-consuming and expensive -- don't go for GMP Certification if GMP Compliance is enough!