Tag Archives: Suppliers

How to Audit and Qualify Manufacturers, Service Providers for cGMP Compliance

MMR-BPR

In hundreds of inspections carried out by FDA since 2009—based on inspection observations released by FDA, many dietary supplement contract manufacturers have been found to be deficient in basic areas of cGMPs (current good manufacturing practices). So it is important for distributors who outsource their manufacturing activities to ensure their suppliers are compliant with the cGMPs and other applicable regulations. Creating simple, efficient and cost-effective ways to pre-select potential contract manufacturing partners prior to engaging in a formal contract is crucial to both the quality of the final product and the success of the partnership. Due diligence at the early stages of engagement increases the chances that the final firm selected will be compatible with the own-label distributor’s business needs and the requirements for cGMP compliance…

More: http://www.naturalproductsinsider.com/articles/2015/08/how-to-audit-and-qualify-manufacturers-and-servic.aspx

I will speak on “How to Audit and Qualify Suppliers for cGMP Compliance” as part of the GMP Workshop at SupplySide West. The three-hour workshop will take place on Friday, Oct. 9, at Mandalay Bay in Las Vegas. Visit http://west.supplysideshow.com/workshops.aspx for the complete agenda and to get registered.

Speaking: Contract Manufacturing Workshop – SupplySide West, Oct 9, 2015

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Friday, October 9 
8:30-11:30am

There are myriad considerations around selecting and working with a contract manufacturer/private label provider and understanding them could be the difference between a successful product launch with a long-term partner, and a disappointment in the market. Experts in the field share their insights into auditing and qualifying suppliers for GMP compliance, understanding finished product specifications and your obligations, risk assessment, and best practice tips for selecting the right manufacturing partner.

8:35-9:05am

Key Considerations in Selecting and Working with a Contract Manufacturer: How to Audit and Qualify Suppliers for CGMP Compliance 
Recent FDA and other enforcement activities indicate dietary supplement firms are responsible for choosing CGMP-compliant contract manufacturers and suppliers. This session provides simple steps and actions you can take to minimize risk, protect your brand, and prepare you to audit and work in partnership with your suppliers for maximum compliance.

You will learn:

  • Best Practices: Simple, efficient and cost-effective ways to pre-select and audit your contract partners.
  • Quality Agreements: When and why do you need one? What items must be included?
  • Supplier Qualification: Tools for risk assessment and verifying that your label claims are met.
  • Quality Control: How much and which QC operations must you perform before product distribution?

SPEAKER

Marian Boardley, principal, Marian Boardley Consulting LLC