It has become common for companies in various industries to outsource raw material supply to external partners. Dietary supplement manufacturers, by necessity, must source raw materials worldwide, although global sourcing comes with various risks and benefits with regard to cost and production. It is therefore incumbent upon manufacturers to have quality controls and systems in place to purchase materials that meet their production needs. For dietary supplement manufacturers seeking to outsource the supply of raw materials, there are several principles that can serve as best practices for maintaining a mutually beneficial international partnership:
1. Find a partner that shares a standard for quality.
For supplement manufacturers that market pharmaceutical-grade products, it is important to choose a supplier that adheres to the same standards for quality. Inconsistent quality in raw materials can hinder production capabilities and pose a major threat to one’s brand name and the consumer. A company must therefore view its outsourcing partner as an extension of its brand. In such cases, the success of the relationship depends on a mutual understanding of business objectives and shared corporate values for maintaining product quality.
2. Conduct thorough qualification checks.
Once a potential outsourcing partner is identified, it is important to check the partner’s qualifications thoroughly. The qualification process consists of three steps. The first is pre-qualification, in which the manufacturer provides the potential raw materials supplier with detailed information regarding product specifications and criteria, and also secures sample materials from the supplier. The manufacturer then tests those samples to ensure they meet the specifications and criteria for the product. The samples are tested, at minimum, for identification (i.e., to confirm the ingredient is what it is supposed to be), strength, purity and presence or absence of microbiological contaminationall of which are essential to product quality.
As a second step, the manufacturer sends a series of questionnaires to the supplier to ensure the supplier’s facility has quality systems in place and complies with regulations (not only those that the supplier must adhere to in its home market[s], but also those regulations that apply to the manufacturer). The manufacturer then collects and analyzes the data generated by the questionnaires and considers those data in evaluating the supplier’s qualifications.
The last step in qualification is on-site auditing, whereby the manufacturer inspects the supplier’s facility to ensure it is well-maintained, and also to confirm that manufacturing standards are being met. The inspection entails a close look at every step of the raw material production process. The manufacturer must confirm that the supplier has the requisite documentation, the appropriate equipment to produce the ingredient in sufficient quantities, and has reduced or eliminated the risk of contamination. As in the pre-qualification phase, the raw material is tested at a critical control pointbefore it goes out the doorto ensure adherence to the manufacturer’s specifications. The audit reviews the suppliers’ documentation, as the manufacturer must ensure that the supplier has documented how the raw material production process is carried out, and that it is consistent and accurate. The documentation should note which personnel are responsible for specific tasks (such as checks for time and temperature) and when those tasks are performed, as well as whether (and when) those personnel have been properly trained.
It is important to note that qualification is a risk-based process. If the manufacturer intends to procure a high-volume raw material, the qualification process must be accompanied by thorough risk assessment. The level of risk will also determine the degree of monitoring that will be required, in that the higher the level of risk, the more closely the supplier must be monitored.
3. Maximize partners’ regulatory acumen.
Having an international outsourcing partner can be a tremendous advantage in ensuring the quality of imported raw materials, particularly when ingredients are subject to rigorous regulatory standards in their home markets. For example, Nutramax Laboratories partnered with the biotechnology company Bioibérica to produce chondroitin sulfate for its Cosamin®DS joint health supplement. The chondroitin sulfate CS b-Bioactive®, one of the active ingredients in Cosamin®DS, is regulated as a pharmaceutical in Western Europe. As the supplier of that ingredient, Bioibérica must conduct numerous quality checks in order to pass regulatory muster in its target countries. Moreover, as a regulated pharmaceutical, the quality of the ingredient must be validated in clinical studies. While this practice may add to production costs, the rigorous testing and validation helps ensure the ingredient’s quality, making the extra steps well worth it for your business.
Wonda Kelly, quality engineer at Nutramax Laboratories, is a member of the American Society for Quality (ASQ) and is a certified quality auditor and manager of quality/organizational excellence with more than 20 years of experience in quality assurance.