In Covid-19 Storm, Supplement Manufacturers' Safe Harbor Could Be Qualifying New Suppliers

US manufacturers losing ingredient supplies from China may need to qualify more suppliers, potentially requiring tests of all lots, says EAS Consulting. Contract and other manufacturers also should identify alternative sources for materials they receive from China and prepare for shortages from other countries.

The Covid-19 pandemic will challenge US dietary supplement manufacturers to remain compliant with good manufacturing practices as ingredient supplies become more difficult to acquire and costs increase as they turn to new suppliers, say regulatory consultants.

EAS Consulting Group LLC, which advises on supplement, food, cosmetics, pharmaceutical and biological industry regulations, has suggestions for practices to help firms, including contract manufacturers (CMs), remain compliant with the Food and Drug Administration’s supplement GMP regulations, including taking time and incurring costs to qualify additional suppliers.

Tara Couch, the Alexandria, VA-based firm’s senior director for dietary supplements, said manufacturers should identify alternative suppliers that they have not already qualified if existing supplies run out. “Full testing to the entirety of the specification parameters must be performed,” she said.

EAS Consultant Tara couch: “If suppliers who have not been qualified are used, full testing of each shipment of each lot of material must be conducted."

“If the disruption persists, CMs will then have to assess whether a qualification of the alternative supplier is beneficial,” Couch said in an email. The assessments can be done by weighing the costs of qualification against simply continuing to test specs for all materials.

Under FDA’s 2007 final rule for supplement GMP, a manufacturer can qualify a supplier by establishing the reliability of its certificate of analysis (CoA), a document provided by the supplier that includes a description of the test or examination methods it used to evaluate a material, the limits of the test and actual results. The manufacturer must maintain documentation of how it qualified the supplier. (Also see "GMP Supplier Qualification Appears More Viable Route Than Testing" - HBW Insight, 8 Feb, 2010.)

However, a manufacturer also can choose not to rely on the supplier’s CoA and instead conduct tests to evaluate all material for compliance with all specifications. Because those tests would have to be done continually, qualified suppliers are “preferred suppliers to reduce both testing costs and timelines,” Couch said.

“If suppliers who have not been qualified are used, full testing of each shipment of each lot of material must be conducted. This will be added testing expense for the CM.”

Nonetheless, suppliers that manufacturers haven’t already qualified may be their only choice as supply chains are disrupted by the Covid-19 pandemic.

 

 

CDC's Outbreak Data

The CDC reported that through 4 p.m. EDT on 18 March:

• Total US Covid-19 cases: 7,038;

• Total deaths: 97;

• Jurisdictions reporting cases: All states and Washington, DC, Puerto Rico, Guam, and US Virgin Islands.

The data include both confirmed and presumptive positive cases of Covid-19 reported to CDC or tested at CDC since 21 January, with the exception of testing results for persons repatriated to the US from Wuhan, China and Japan.

“If the disruption persists, CMs will then have to assess whether the qualification of the alternative supplier is beneficial. It will save time and money eventually, but the qualification process itself is a multi-step process,” Couch said.

The process includes a documentation audit through a “thorough and detailed supplier qualification questionnaire, a subsequent on-site supplier facility audit and confirmation testing of the CoA that typically involves full testing to the specification for a minimum of three unique lots of material.”

Manufacturers aren't alone in the supplement sector potentially threatened by the pandemic, The Natural Products Association is urging states to deem natural health product stores as "essential businesses" allowed to remain open during the crisis and to allow them to apply for s Economic Injury Disaster Loan assistance (see sidebar article).

Preparing For Impact

NSF International, an Ann Arbor, MI-based firm that consults with nutritional products companies on GMP compliance, accreditation programs and testing services, also suggests manufacturers find alternative sources for materials.

Toni Dallas, manager of NSF’s TraQtion cloud-based quality and compliance software that helps manufacturers manage supply chains for brands across 90 countries, advises that firms first assess which of their facilities are in regions reported to have Covid-19 cases.

“Assess your risk level to Covid-19 by overlaying the [World Health Organization] surveillance data of confirmed and suspected cases of Covid-19” with TraQtion or other supplier databases companies can access, Dallas said.

“Supplier facilities that overlap with the affected regions are at a higher risk for labor shortages, factory shutdowns or port closures, which potentially impact factory production,” she said.

Dallas said manufacturers should consider contacting facilities in outbreak zones as well as suppliers’ headquarters to discuss potentially redirecting shipments from facilities in safe regions.

Manufacturers should prioritize finding alternative suppliers of sole-sourced or high value products currently coming from viral hot zones. “The shortest path to an alternative would be to use an inactive, yet approved supplier already in your network,” Dallas said.

Dallas said TraQtion clients can search its “comprehensive” supplier master database to access lists of suppliers providing needed ingredients. “Determine if an inactive, yet pre-approved supplier sources the same product and if they qualify as an alternative for this duration.”

Couch added that finding alternative suppliers now also is critical as the issues with supply are likely to ripple beyond China. For example, India is systemically reducing the export of certain drug and supplement products – including acetaminophen and vitamins B1, 6 and 12 – to the global market in order to ensure they have adequate supplies for their domestic purposes, she said.

Companies looking to switch their supplies from China to other sources must be careful to comply with Food Safety Modernization Act’s foreign supplier verification program requirements to ensure that new partners are the original sources of ingredients and are not secretly sourcing sub-components from mother entities. (Also see "Foreign Supplier Verification Concerns Grow On Supplement Firms" - HBW Insight, 16 Sep, 2016.)

The United Natural Products Alliance stated disruptions of natural product ingredient supply linked to coronavirus outbreak will extend until mid-year, with levels of many materials critical by the third week of April. The issue is huge for industry since 75%-80% of US raw materials are sourced from China. (Also see "Covid-19 Disrupting Supply Chains Short-Term, Could Spark Long-Term Procurement Shifts" - HBW Insight, 12 Mar, 2020.)