Selection Criteria and Quality Requirements for Dried Vegetable Raw Materials for Pharmaceuticals and Health Foods

What you will learn from this article

• The quality standards required of dried-vegetable raw materials for pharmaceuticals and health foods
• Concrete checkpoints when choosing a GMP-compliant factory
• How to build a supply chain that achieves stable supply
• Standard values and control systems for residual-pesticide and microbial testing
• Negotiation tactics to optimize raw-material sourcing costs

“I want to use dried vegetables as an ingredient for a health food, but what quality standards do I need to clear?”

This is the first wall you hit when you become the person in charge of raw-material sourcing, isn’t it? In the pharmaceutical and health-food fields especially, far stricter quality control than for general foods is required.

We at Agriture have been manufacturing dried vegetables in Kyoto for over 10 years, and inquiries from pharmaceutical and health-food makers are increasing year by year. Through actually advancing transactions, we’ve come to see the points where “nail these down and you’ll be fine.”

This article conveys concretely—from quality requirements to supply systems—so that people in charge of raw-material sourcing can make decisions without getting lost.

What are the quality standards required of dried vegetables for pharmaceuticals and health foods?

General foods and pharmaceuticals/health foods have completely different standards

The dried vegetables used in general food processing and the raw materials for pharmaceuticals and health foods require fundamentally different quality levels.

What you want to note here is that there’s a big gap between the legal minimum standards and the standards actually required by your business partners. In transactions with major pharmaceutical makers in particular, in-house standards that are even stricter are the norm.

How to tell whether a factory is GMP-compliant

GMP (Good Manufacturing Practice) is a standard for manufacturing and quality control, but it’s easy to just say “we’re GMP-compliant.” Here we’ve compiled the points you should actually confirm.

At Agriture, we retain manufacturing records for over 3 years so we can accommodate our partners’ factory audits. Frankly, being flustered when asked to “provide the documents” falls short on reliability, doesn’t it?

Items to include in the raw-material specification

The raw-material specification is the document at the core of a transaction. At minimum, confirm that the following items are covered.

• Raw-material name, variety, origin
• Drying method (hot-air, freeze, reduced-pressure, etc.)
• Water-activity value (Aw value)
• Particle-size specification (mesh size)
• Microbial standard values (total viable count, coliforms, fungal count)
• Residual-pesticide test items and standard values
• Heavy-metal standard values
• Allergen information
• Storage conditions and expiration date

Concrete control systems for residual-pesticide and microbial testing

Analysis items to nail down in residual-pesticide testing

For dried-vegetable raw materials for health foods, testing based on the positive-list system alone is insufficient.

What partners especially require is testing that covers 200-plus items via batch analysis (multi-screening). It costs around 30,000–50,000 yen per sample, but skimping here leads to major problems later.

At Agriture, we conduct residual-pesticide testing at two stages—at raw-material receipt and at product shipment. Nailing it down at both the “entrance” and the “exit” minimizes contamination risk in the unlikely event, you see.

Practical points for microbial control

Dried vegetables have low water activity, so the risk of microbial growth is low—but for pharmaceuticals and health foods, “low” won’t do.

Even for dried vegetables that have gone through a heat-sterilization step, there’s a risk of secondary contamination in the milling and sieving steps. Hygiene management between these steps is actually the biggest point. A control system that oversees the entire manufacturing line is needed.

Testing for heavy metals and radioactive substances

In recent years, requests for heavy-metal testing have increased, especially from health-food makers who also have overseas exports in view.

The basic heavy metals to test are four: lead (Pb), cadmium (Cd), arsenic (As), and mercury (Hg). Since the risk differs by origin and vegetable type, we recommend always obtaining analysis data at the first transaction.

Building a supply chain that achieves stable supply

The idea of “origin diversification” needed to reliably secure raw materials

The scariest thing in sourcing dried-vegetable raw materials is a shortage due to poor weather. Relying on a single origin means a single typhoon or spell of prolonged rain can stop supply.

At Agriture, we conclude annual contracts with multiple contract farmers, centered on Kyoto. Specifically, in addition to our main Kyoto-grown supply, we’ve concluded backup contracts with farmers in Kyushu and Hokkaido. This way, even if one origin has a poor harvest, we maintain a system that secures 70% or more of the supply volume.

Guidelines for inventory management and order lead times

We do actually get many requests like “we urgently need 100 kg,” but there are limits to short-lead-time support while ensuring quality. Planned ordering ultimately leads to cost savings, too.

The merits and risk hedging of long-term contracts

Concluding an annual contract secures price stability and a guarantee of priority supply. However, there are points to note.

• Putting 80% of annual usage under long-term contract and 20% on spot purchase is a good balance
• Always include a price-revision clause (to respond to raw-material market fluctuations)
• Agree in advance on handling rules for quality non-conformance

Optimizing raw-material costs and points for price negotiation

Understanding the price structure of dried-vegetable raw materials

Before price negotiation, understanding the cost structure first is important.

3 ways to cut costs without lowering quality

1. Scaling up the lot size
Increasing the volume per order improves drying efficiency, and there are cases where you can lower the unit price by 5–15%.

2. Reviewing the specifications
Reconsider whether that particle size is really necessary. Simply right-sizing an over-spec requirement can improve yield and lower costs.

3. Ordering to match the season
A method of drying and processing in bulk to match the vegetable’s season and stocking it. Raw-material costs can be nearly 30% cheaper in season, so if you have storage space, it’s well worth considering.

Agriture’s quality-control system for pharmaceuticals and health foods

Integrated manufacturing at our own factory in Kyoto

Agriture has its own factory in Kyoto, handling everything from raw-material sorting to drying, milling, and packaging in one integrated process. Precisely because we don’t outsource, we can secure traceability across every step, you see.

The main equipment and features of our factory are as follows.

• Hot-air dryers (3 large units): can handle large lots
• Freeze dryer (freeze-drying): a method excellent at retaining nutrients and color
• Mills (multiple mesh-compatible): particle size adjustable from 20 mesh to 200 mesh
• X-ray foreign-matter detector: detects non-metallic foreign matter as well
• Constant-temperature, constant-humidity storage: a storage environment that prevents quality degradation

Prototyping support from small lots

We accommodate even the “we just want to try it out first” stage. Prototyping from a minimum lot of 10 kg is possible, so please consult us even at the early stage of product development.

The general flow from prototype to mass production is as follows.

Summary

When selecting dried-vegetable raw materials for pharmaceuticals and health foods, be sure to confirm the following points.

• Quality standard: Whether there’s a residual-pesticide, microbial, and heavy-metal testing system stricter than for general foods
• GMP compliance: Confirm the certification status and actual operational level via a factory tour
• Supply stability: Whether there’s a system for origin diversification and inventory management
• Cost transparency: Whether the price structure is clear and there are optimization proposals that maintain quality
• Traceability: Whether history tracing from field to product is possible

Raw-material selection is the most important step in determining a product’s quality. Choosing on the sole basis of “it’s cheap” means facing costs many times higher later from recalls and quality trouble.

At Agriture, we send raw-material samples free of charge to pharmaceutical and health-food makers. If you’d like to discuss quality standards and supply systems in concrete terms, please feel free to contact us.

FAQ

Q1: Is there a difference in quality standards for dried-vegetable raw materials between pharmaceutical and health-food use?

The basic control items are common, but pharmaceutical use has stricter microbial standards and foreign-matter control. Pharmaceutical use often requires conformance to the GMP ordinance, while health foods generally comply with voluntary standards such as JIHFS GMP.

Q2: What’s the smallest lot you can handle?

At the prototype stage, we can handle from 10 kg. For mass production, 100 kg and up is a guide, but it varies by item and processing, so please consult us first.

Q3: Do you handle Organic JAS-certified dried-vegetable raw materials?

We handle Organic JAS-certified raw materials as well. However, since organic raw materials have limited supply, we recommend ordering early. The lead time may be 1–2 weeks longer than for standard products.

Q4: Can you issue documents for overseas export (CoA, etc.)?

We can issue an English-language CoA (Certificate of Analysis). Since the required test items and formats differ by destination country, if you consult us in advance we’ll prepare it in the appropriate format.

Q5: What happens if residual pesticides exceed the standard value?

If an exceedance is found in testing at raw-material receipt, we designate the entire relevant lot as unusable and switch to manufacturing with an alternative raw material. We have a system in place to report test results promptly and to submit a written cause investigation and recurrence-prevention measures.

Q6: Can you accommodate factory tours and quality audits?

We accept factory tours and quality audits by advance reservation. Beyond touring the manufacturing line, we can also accommodate viewing of quality-control records and meetings with staff. If you come to Kyoto, you can confirm the actual manufacturing site in person.

Recommended reading

Commercial dried vegetables / Drying processing service / Contract processing service / Freeze-dried popular-ingredient ranking | Recommendations by application and points on how to choose, thoroughly explained / A guide to switching from fresh vegetables to dried-vegetable raw materials | Cost savings and stable sourcing

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