IPA UPDATES - Probiota Americas · 2019. 6. 26. · Kevin Mehring President, International...

The Global Voice of Probiotics® www.internationalprobiotics.org

IPA UPDATESMANUFACTURING COMMITTEE

Kevin MehringManufacturing Committee Chair

International Probiotics Association


The GOOD

Our industry continues to exhibit steady growth in multiple global markets

The vast majority of reputable brands and CMO’s are making/selling high quality products

The BAD

New CMOs (or CMOs which are new to probiotics) have come quickly to this attractive segment

Some with little to no experience handling live bacteria/microorganisms

CMO competition has gotten fierce in multiple markets (pricing, margin compression)

FACILITY SHORTCUTS – especially in expensive HVAC

FORMULATION SHORTCUTS - overages not scientifically determined or insufficient for shelf life

The potentially UGLY?

Ultimately consumer confidence gets shaken if product quality issues arise or aren’t effective

GUIDELINES = LEVEL the PLAYING FIELD & PROTECT INDUSTRY

The Situation at HandWhy Complaining Leads to Volunteering


1. IPA Manufacturing Committee

Contributing IPA member companies

Charter - refresher

Objectives- refresher

3. Guidelines for Manufacturing

Part 1: Process Map

Part 2: Detailed guidelines

2. Industry Feedback & Process so far

Membership Survey

Comments periods

Physical meetings & Working groups

4. Next Steps

3rd party auditing program

Communication plan

Today’s TopicExecutive Summary


IPA WORKING COMMITTEE

- MANUFACTURING PROBIOTIC FOOD SUPPLEMENTS-


IPA Working CommitteeManufacturing – Contributing Members – Global input!


To advance probiotic manufacturing guidelines within the industry

facilitating communication between industry members & regulatory bodies

To speak in the name of the probiotic industry and be involved in sharing probioticmanufacturing guidelines across the globe

Guide and educate the expanding industry so quality is maintained

Industry and ultimately the consumer is protected

IPA Working CommitteeManufacturing - Charter


Monitor and analyze regulations related to probiotics in all major jurisdictions

In concert with IPA Regulatory Committee

Equip new as well as current industry players with proper guidelines

Considerations in manufacturing processes specific to good bacteria

NOT a substitute for local regs. Addresses probiotic specific considerations to achieve regs

Highlight various ways to achieve end of shelf life label claim & maximize product quality

Use guidelines as an Educational tool

For manufacturers to identify process improvements/risk reduction, while providing guidance on achievingcompliant products of highest quality

For brand owners to ask right questions and collaborate to help their manufacturer’s effectively enact GMPs

For regulators to understand the uniqueness of the category and the special considerations when manufacturingwith probiotics

Protecting end-users in general by increasing awareness of supplement GMPs

Instilling credibility and confidence in the probiotic sector!

IPA Working CommitteeManufacturing - Objectives


INDUSTRY FEEDBACK

- MEMBERSHIP INPUT -


Survey An in-depth survey with guidelines sent out to membership

Comments – Multiple rounds 1st Round - Over 100 comments from +20 member companies

2nd round of comments completed in September 2018

Working Groups Working Group Sessions (3)

Each group reviewed their respective section of the document and all relevant comments from membership; draft document was updated accordingly

Physical Meetings & Fellow Committee Input Meeting at Probiota Miami & SSW Las Vegas in 2018

Update document by incorporating member feedback – continuous improvement mentality

Fellow committee review of final draft document - Regulatory & Education/Communication

Industry FeedbackMembership Input – Critical with multiple touch points


GUIDELINES FOR MANUFACTURING

- IPA OUTPUT -


THREE MAJOR SECTIONS

Manufacturing Facility – General

Product Development/Piloting

Actual process steps:

Bulk Probiotic Material (e.g. powder

ingredient)

Receiving

Incoming QC Inspection & Sampling

QC Testing of Incoming Cultures

Retain Samples

Stability Samples (if applicable)

Quarantine Process - Incoming

Released Materials Warehouse

Weigh/Dispense

Blending

Guidelines for ManufacturingPart 1 – Process Map is Foundation

Intermediate Blends Storage

Dosage Form Manufacturing

Bulk Dosage Form Storage

Packaging

QC Testing of Finished Products

Quarantine Process – Finished Product in QC Testing

Finished Product Storage

Shipping


Process Step (linked to the Process Map)

Stage

Location within the Facility

Process Details

Acceptable

Optimal (Best Practices)

Corresponding Recommended Guidance

Including global regulatory reference (where applicable)

Guidelines for ManufacturingPart 2 – Detailed Guidelines


Process Step

Manufacturing Facility – General

Stage

HVAC System

Location within the facility

Utilities

Process details:

Acceptable Process

Established number of air changes per hour with filtration on feed air, heating and cooling air,

dehumidification and exit air where product is exposed.

Optimal (Best Practices)

Monitoring and controlling conditions, established number of air changes per hour with terminal HEPA filters in areas where product is exposed, ensuring that the pressure differential is set and monitored accordingly.

Corresponding Recommended Guidance (global regulatory references)

• ISPE – International Society of Pharmaceutical Engineers

Annex 5 - Supplementary guidelines on GMP practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms

Guidelines for ManufacturingPart 2 – Detailed Guidelines - EXAMPLE


NEXT STEPS

- PROBIOTIC MANUFACTURING -


3rd Party AUDITING

Not meant to replace DS cGMP audits but rather to enhance probiotic specific topics

Conducted in coordination with annual cGMP audit for efficiencies

Determine each step in process as ACCEPTABLE or OPTIMAL, and areas for improvement

Possible 3rd party auditors to lead the effort:

Expected start Q2 2020 – gives time for members to conduct internal audits and improve

Incorporate with other IPA Committee initiatives

for a centralized auditing/certification process

Next StepsA Guideline for Manufacturing


Communication Plan

IPA Membership Soft launch done

IPA Manufacturing Committee delegates – Week of June 10th 2019

IPA Members – Week of June 17th 2019

IPA World Congress & Probiota Americas Official launch – June 26th 2019

Press & Industry – Q3 & Q4 2019

NutraIngredients

Natural Products Insider

Regulators – Q3 & Q4 2019

ANVISA

Health Canada

FDA

Argentina

Next StepsA Standard for Manufacturing

China

EFSA & EU commission

TGA

and more to come…

Nutrition Insights

Vitafoods Insight

Whole Foods Magazine

Integrative Healthcare Practitioner

and more…


Thank You

Questions?

Kevin MehringPresident, International Probiotics Association President & CEO, UAS [email protected]

mailto:[email protected]

REFERENCES & CONTACT DETAILS


The International Probiotics Association (IPA) is a global non-profit organizationbringing together through its membership, the probiotic sector’s stakeholders includingbut not limited to academia, scientists, health care professionals, consumers, industryand regulators. The IPA’s mission is promote the safe and efficacious use of probioticsthroughout the world. Holding NGO status before Codex Alimentarius, the IPA is alsorecognized as the unified Global Voice of Probiotics® around the world.

George ParaskevakosExecutive Director

(514) 571-5949

[email protected]

mailto:[email protected]

https://www.instagram.com/explore/tags/internationalprobioticsassociation/?hl=en

https://twitter.com/IP_Association

https://www.linkedin.com/company/8406650/

IPA UPDATES - Probiota Americas · 2019. 6. 26. · Kevin Mehring President, International...

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