The Right Compliance – March 2018

The Right Compliance – March 2018 | REJIMUS

Remote cGMP Auditing - eeehhh?

by Ingredient Identity *|FACEBOOK:LIKE|*

Wow, what a year so far! It is already Expo West time and the Ingredient Identity team is revamped, more specialized and embarking on some really exciting services. Let us know if you are attending and would like to meet up!

In addition, we are pushing for strategic market expansion with the establishment of new subsidiaries in international office locations to be established this year. (HINT: I'm heading back down to Mexico very soon).

We started this year with an eye on expanding well beyond the typical "regulatory consulting" work, to build on a platform of different technologies that streamline the product development processes of our clients with respect to all the quality and compliance requirements. What's all that really mean? It means more cost-efficient resources that can be independently utilized by new and/or lessor experienced industry personnel to mitigate overall legal and regulatory risks when it comes to specific quality and regulatory operations i.e. you have no excuse to not be compliant, no matter how small of a company you have! If that still isn't clear, call me so we can chat!

One of the newest approaches we are implementing is a recent development of a wearable tech partnership. Boom! We are now launching remote cGMP Facility Audits for 21 CFR Part 111 (Dietary Supplement Manufacturers, Co-packers, Distributors, etc.) and for 21 CFR Part 117 (Food & Beverage Manufacturers, Food Ingredient Suppliers and Dietary Ingredient manufacturers). Yep, we are aiming to reduce the overall cost of and timing for facility audits by half...or more! Who does that? Oh yes, we do! We stay here, you stay there, we audit your facility. Big cost savings across the board! While this will not outright replace in-person audits across the board, it will help considerably in other vendors pre-qualifications, technical visits or routine surveillance audits.

To help us hone and optimize our auditing protocols for this new Remote cGMP Auditing Service even more, we want to bench test a few more clients' business models. So we are giving away Free GMP Audits! Now, we are only picking one company for each business model below to audit, JUST ONE!. If you have one of these business models here in the United States, we want to hear from you, so please read carefully:

  • Warehousing/Distributor Only - for Finished Food Products
  • Warehousing/Distributor Only - for Dietary Supplement Finished Products
  • OLD (Own-label Distributor) - for Dietary Supplement Finished Products
  • A Food Ingredient Processor of Plants/Botanicals Only - No animal based food/ingredient processors at this time
  • Dietary Supplement Manufacturer (with less than 25 total employees)

Here's what you need to do in order for us to select the winners (no applications necessary)...and yes, you gotta do each one, because we are going to check:

  1. Ensure your business model is listed above (we will still have to qualify you)
  2. Log into LinkedIn, and go to our Ingredient Identity LinkedIn page and click to Follow Us.
  3. Go on your LinkedIn personal home page, and in your status update section, give us big shout out to "@Ingredient Identity" - make sure it tags the company, not Jim! ;) 
  4. For the next few weeks until March 31st, 2018 - Like and share other posts you see in your LinkedIn News feed regarding us...the more that you do, the more we can track from your likes, shares and related posts, and it all adds to be qualified and selected for a free cGMP audit of your operations at the end of March
Disclaimers: You must be a brand new customer we've never worked with before. You agree to be showcased by Ingredient Identity on our website and other marketing efforts for this specific service. The facility must be based in the United States - we will be rolling out support for other international based companies very soon. The facility in question, must be your facility/company, NOT ONE OF YOUR VENDORS. You cannot have an existing warning letter or other regulatory action against your company, or be involved in a litigation matter relating to a quality or compliance issueYou must agree to have the audit to be scheduled in the next 6 monthsThis Free Facility Audit and Audit Report offer DOES NOT include: 1) Pre-Audit Preparation Time Required, 2) Shipping Costs for the Google Glasses, 3) Insurances and 4) Other support following the audit itself only if required.

Rest assured, if you are not selected for the Audit, you can still utilize us as your trusted regulatory partner for labeling and marketing reviews or other services. Vendor Audits will depend on the vendor allowance since this is a new approach to saving both sides a considerable amount of time and costs; prior approval will be required from all parties. If you are still interested in a Remote cGMP Auditing services, please let us know and we'll reach out to coordinate so you can learn more. 

Questions anyone?

I'm looking forward to hearing from you!

Kindest regards,
Brandon Griffin, CEO

Specialized GMP Training - Our QDS and RGS team members lead this offering that focuses on specific business models to ensure uniform and consistent approaches to better ensuring compliance. This is the program that gives the fundamentals, structure and documentation to have a compliant operation day one! 

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