Contract manufacturing is the most-customized sourcing model. The factory dedicates a production window to your SKU, your spec, your raw materials. Everything from the formula and the equipment cleaning protocol to the QC sampling plan is documented in a Master Manufacturing Record (MMR) and a Quality Agreement.

The Quality Agreement is the binding document. FDA's guidance on contract manufacturing quality agreements specifies that responsibilities for change control, deviation handling, batch release, and post-market reporting must be assigned in writing — there is no "we'll figure it out later." Without a Quality Agreement, you do not have a contract manufacturing relationship; you have a purchase order.

MOQ math: contract runs need to amortize line changeover, raw material qualification, and QC overhead. Capsule contract MOQs typically start at 25,000-50,000 bottles. Powder blends start at 250-500 kg of bulk powder. Gummies start at 50,000-100,000 units. Beverage contract runs need 5,000-25,000 cases.

Lead times for first runs run 16-26 weeks because of formula validation, stability testing, raw material qualification, and an initial pilot batch. Reorders compress to 8-14 weeks once everything is documented and validated.