contract service providers · • regulatory consulting firm specializing in food, food supplement,...

Information Classification: General

Contract Service ProvidersOvercoming Quality Hurdles When Working

With Contract Manufacturers and Co-

Packers

Cory Carter, MJ

CEO, Carter Regulatory Group

www.regminds.com


Carter Regulatory Group• Regulatory consulting firm specializing in food, food supplement,

cosmetic, drug regulations and quality systems

• Operating in over 40 countries

• Former regulatory inspectors, Regulatory Experts, Chemists, Biologists

• Product safety and quality systems

• Label reviews

• Advertising reviews

• Auditing

• FDA warning letter and 483 responses


Auditing

• Types of Audits•On-Site Audits•Desk Audits or Documentation Audits•3rd Party Audits


On-Site Audits

•Picture is worth a thousand words

•Observe, first hand, whether following procedures

•Observe cleanliness

• Establish expectations


Desk Audits

• In-depth look at written procedures

•Ability to identify gaps in written activities

•Advantage of time

•Avoid misdirection

• If isn’t documented, it didn’t happen


3rd Party Audits

•Benefit of experience

•Ability to see what would normally not be observed

•Written audit programs

•Written report and observations


• Facilities change

•Products change

•Continuous improvement is a sign of responsibility

•Continued involvement = happy regulators

•Protect your brand

Importance of Follow-Up


• Attend an audit with an experienced auditor

• Take notes

• Ask questions

• Don’t let the manufacturer be your guide

• Ask to see areas the manufacturer doesn’t offer as part of the tour

• Trust your instinct

• Go in with eyes wide open

• Don’t let market entry strategy or price cloud your vision and judgement

• Realize nobody is perfect

Tips for Avoiding Auditing Tricks


• A written contract or agreement, outlining the following:• Manufacturer roles and responsibilities

• Customer roles and responsibilities

• Manufacturer authorizations

• Customer authorizations

Quality Agreement


• Manufacturer roles and responsibilities• Documentation and Retention

• Retention Samples

• Notification of Regulatory Audit

• Recall

• Certifications (BRC, SQF, NSF, etc) and Audit Reports

• Deviation Notifications

• Specification Development

• Labeling

• Testing

• Inspecting Raw Materials and Packaging

Quality Agreement


• Customer roles and responsibilities• Label Development/Accuracy

• Formulation

• Specification Development

• Communication With Manufacturer (ie, change in specification, change in ingredient, change in label, change in packaging)

• Approval of Manufacturing Processes and Testing

• Review and Approval of Deviations

• Notify Manufacturer in Event of Regulatory Action, Recall, or Adverse Events

Quality Agreement


• Manufacturer Authorizations• Substitute Ingredients

• Approve and Implement Deviations or Corrective Actions

• Display Product to Potential Clients

• Product Sampling

• Non-Conforming Product Disposition (give away?)

• Destroy Product and Labels

• Revise Labels According to Formulation/Testing Changes

Quality Agreement


• Customer Authorizations• Inspect Facility With Reasonable Notice

• Review Batch Production Records

• Approve or Reject Deviations/Corrective Actions

• Review and Approve Batch Records Prior to Release

• Define Specifications

• Own Formula

Quality Agreement


• Sample Language

• Upon written request, Manufacturer shall grant access to Customer to review and audit any and all food safety plans, procedures, policies, work instructions, batch records, cleaning and sanitation records, testing and laboratory records, certificates of analysis, data logs, personnel records, and any and all other documents required to be maintained according to applicable laws and regulations and associated with any and all Products; or ingredients, components, or packaging materials of such Products; produced on behalf of Customer.

• Manufacturer shall notify Customer of any deviation or non-conformance related to the receipt, processing, manufacturing, packaging, labeling, or distribution of any Product. Manufacturer shall not implement any corrective action or disposition decision without written authorization from Customer.

Quality Agreement


• Sample Language• Manufacturer shall adopt and maintain quality assurance procedures,

perform periodic quality control tests, conduct audits, maintain records, and implement measures to ensure that the Facility and the operations of Manufacturer, including its manufacture of Products for Customer, conform to Current Good Manufacturing Practices, as set forth in 21 C.F.R. Part 110 and associated guidance documents, conform to food safety standards and regulations, as set out in 21 C.F.R. Part 117 and associated guidance documents, conform to industry best practices, the Specifications, and all other applicable US laws and regulations.

• Manufacturer shall purchase all ingredients required for the manufacture of the Products. All ingredients and packaging must meet Specifications prior to use. Manufacturer shall not substitute ingredients or packaging without written Customer approval.

Quality Agreement


• Standardized auditing program

• Repeat visits

• More stringent requirements (typically)

• Pay to play value and discount• Both a benefit and a risk

• Ask for level of certification and copy of previous audit• SQF LVL 2 vs LVL 3

3rd Party Certification


CARTER REGULATORY GROUPRegulatory Minds For A Global Economy

Cory Carter, MJ

Founder/CEO

[email protected]

Office 208.357.408

www.regminds.com

http://www.regminds.com/

contract service providers · • regulatory consulting firm specializing in food, food supplement,...

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