Frequently asked questions
Can you help us develop a product idea?
Yes, our team of experts is at your service and will be happy to discuss possible product ideas with you. Together we will compose a beautiful and innovative product.
From which range of raw materials can we choose as a customer?
Our goal: differentiation for every customer in order to put a unique product on the market. The ingredient composition is certainly important here. To help you with this, we have divided our raw materials into a wide range of categories called X-Selection. In this way, it is quickly clear which raw materials fit which trend. Do you want a unique raw material that we do not yet have? Then we will be happy to source it for you and include it in our range.
I have my product produced elsewhere. Can you copy this identically?
An exact copy is often difficult to make (especially with tablets). We can dose the elementary substances exactly the same. But the shape and appearance depend on the machines and excipients used. Naturally, our product will approximate the existing product as closely as possible. When it comes to chewable tablets, taste tests are often necessary which can be included in the development process.
Which certificates does SoliPharma have?
We have the following certificates:
- cGMP for production, packaging and storage of medicines (current Good Manufacturing Practice)
- ISO 22000 for food safety
- FSSC 22000 (under development)
- Successfully audited FDA dietary supplements
- GMP + (under development; for the time being we are working in accordance with ISO 22000 and cGMP)
- Kosher (in development; for the time being we work with assessment per product)
- Halal (under development; for the time being we work with assessment per product)
SoliPharma is cGMP licensed. What does this mean for the production of our nutritional supplements?
All products are produced in a cGMP-compliant environment, regardless of whether it is a pharmaceutical product or a dietary supplement. The guarantee that your product is produced by high-quality processes.
SoliPharma is ISO-22000 certified. What does this mean for the production of our nutritional supplements?
We meet the strict food safety requirements set by the ISO-22000 standard. This is a worldwide standard in the field of food safety. Its full name is "ISO 22000 Food Safety Management Systems - Requirements for an Organization in the Food Chain". This standard consists of three parts:
1. Requirements for general hygiene practices ("good practices" or "pre-requisite programs").
2. Requirements for HACCP in accordance with the HACCP principles of the Codex Alimentarius.
3. Requirements for a quality management system.
FSSC 22000 also includes requirements in the field of food defense. Food defense is the protection of the production facility against deliberate contamination.
Do you meet the requirements for HACCP?
Hazard Analysis and Critical Control Points (HACCP) is a risk assessment for foodstuffs. The origin of this lies in American space travel.
SoliPharma B.V. has been certified in accordance with HACCP since 2004 and has been included in the ISO 22000 requirements since 2014. SoliPharma thus guarantees the quality and food safety of all products and processes. Every year there are several audits to be able to keep this certificate. Certifying bodies such as Lloyds, Kiwa, SGS and DNV GL perform these audits.
What legal requirements do your products meet?
All SoliPharma products and packaging materials comply with European (EU) and Dutch food law and guidelines, in particular:
- Commodities Act Decree on food supplements (NL legislation).
- Commodities Act Decree on information on foodstuffs (NL legislation).
- Commodities Act Decree on herbal preparations (NL legislation).
- The Medicines Act and the Opium Act (NL legislation).
- Directive 1999/2 / EC establishing a Community list of foods and food ingredients that may be treated with ionizing radiation.
- Directive 2001/95 / EC on general product safety and amendments thereto.
- Regulation 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (BSE)
- The Food Supplements Directive 46/2002 / EC.
- Regulation 178/2002 laying down the general principles and requirements of food law, establishing a European Food Safety Authority and laying down procedures in food safety matters.
- Regulation 1829/2003 on genetically modified food and feed.
- Regulation 830/2003 on the traceability and labeling of genetically modified organisms and the traceability of food and feed produced with genetically modified organisms.
- Regulation 852/2004 on food hygiene and amendments thereto.
- Regulation 1935/2004 on materials and articles intended to come into contact with food and amendments thereto.
- Regulation 396/2005 establishing maximum levels for pesticide residues in or on food and feed of plant and animal origin and amendments thereto.
- Regulation 2073/2005 on microbiological criteria for foods and amendments thereto.
- Regulation 1881/2006 setting the maximum levels for certain contaminants in foodstuffs and amendments thereto.
- Regulation 1924/2006 on nutrition and health claims made on foods.
- Regulation 629/2008 on heavy metals.
- Regulation 1333/2008 on food additives.
- Regulation 10/2011 on plastic materials and articles intended to come into contact with food and amendments thereto.
- Regulation 1129/2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by drawing up an EU list of food additives.
Does SoliPharma comply with Regulation 1169/2011?
This regulation concerns the provision of food information to consumers and amendments thereto. The person responsible for this regulation is the person who puts the product on the market: the customer. SoliPharma is happy to think along with you.
Are your products produced GMO-free?
All our products comply with GMO legislation. We pay a lot of attention to this in the selection of raw materials. On special request we process GMO raw materials, which we keep completely separate from the other raw materials. We guarantee cross-contamination-free production with an extensive cleaning validation.
Does SoliPharma audit its suppliers?
All suppliers are audited on a monitoring basis and risk assessment. During the supplier selection process, we request documents and suppliers complete a questionnaire.
To what extent are raw materials traceable in your quality system?
Our quality system is set up in such a way that all flows are always fully traceable.
How do I know if my products contains allergens?
With every product that SoliPharma develops and / or produces, the customer receives a Development Sheet including an allergen declaration. If you would like additional information, you can always contact your contact person.
How do I know if my product is vegan?
In the recipe we use ingredients that are indicated as vegan in the X-Selection. As a result, the composite product is also vegan.
How do I know if my product is being produced in accordance with legislation?
The production in the Netherlands fully complies with the requirements set by the Dutch government.
How do I know if my product meets the sales and marketing requirements?
For each composition, a legislative specialist assesses whether it complies with the legislation of the country where the product is placed on the market. If a recipe does not fit within the legislation of the country of marketing, we will look together for possible alternatives.
How do I know if the quality and safety of a delivered product and its raw materials is good?
Every SoliPharma product comes with a Certificate of Conformance (CoC). It states that the product has been produced in accordance with agreed quality and composition. If you would like an extra analysis of the end product, you will also receive a Certificate of Analysis (CoA). We are happy to work out your wishes together with you.
SoliPharma performs a risk analysis on all raw materials. This analysis is based on the NPN risk inventory. This provides an overview of the dangers and their risk in the raw materials of food supplements and the corresponding substantiation. We base and determine the choice and frequency of analyzes for contaminants in raw materials on this basis. The risk analysis is revised as soon as new information or legislation becomes available.
Can I view the CoA of the raw materials offered?
Yes, you can request a copy of the SoliPharma raw material specification. You can also request additional questions about the characteristics of the raw materials. And during an audit you can view the details.
Will I be informed if something changes in a raw material or an end product?
Not as long as a change falls within the existing specification. If this is not the case, you will be informed via a change control.
Are the raw materials standardized?
Standardized raw materials can be recognized by a displayed ratio or a specified amount of active ingredients. If you would like a specific standardization, you can of course indicate this and we will look at the possibilities together.
Are your suppliers certified in the field of food safety (HACCP)?
All our suppliers are certified by an independent third party for food safety and quality. If this is not the case, we encourage the supplier to be certified. We also use a supplier selection procedure. Feel free to ask if you want to know more about this.
When is a developed recipe definitive?
When a new recipe has been delivered three times, the exact composition is definitively recorded. Every composition is unique. The active ingredients are fixed, but the exact composition for excipients cannot always be estimated in advance. This is due, for example, to so-called upscaling effects. In principle, only minor changes take place in the amount of excipients. If this leads to a different order on the ingredient declaration, you will automatically receive a change control.
How are raw materials and end products stored?
SoliPharma has a conditioned warehouse, which also includes a cold store. We store raw materials in accordance with the storage conditions specified by the supplier.
Can you analyze our end products?
Yes, SoliPharma has its own laboratory where we can perform numerous analyzes. We ourselves preventively analyze mainly raw materials. If you want to analyze your end product on certain parameters before it is released, we will draw up a tailor-made analysis package in consultation with you.
When will an end product be released for delivery?
After the Batch Preparation Protocol (CBP), the CVP, the Batch Packaging Protocol and the visual assessment have been completed, the product is released. If there are analyzes of the end product, it will be released after completion.
When is a raw material released for production?
After analyzes - the frequency and type of which are determined on the basis of an extensive risk analysis - show that a raw material meets the legal limits. The CoA is also checked by our QC department and a visual inspection takes place. Only then are raw materials released for production.
What is the difference between a CoC and a CoA?
A Certificate of Conformance (CoC) is a certificate that indicates whether a product meets the agreed specifications. A Certificate of Analysis (CoA) is a certificate that shows the current values of agreed specifications and thus confirms that a product meets the agreed specifications. So a CoC is, as it were, "calculated" on the basis of CoAs of raw materials and a controlled process. And a CoA contains currently measured analysis results of the produced product.
What happens if an Out Of Spec (OOS) is detected?
Then the product will be blocked and we will look for a solution in consultation with you. At the same time, we are investigating the possible cause. Depending on the result, appropriate measures are taken. And to prevent recurrence, we process the solution with Corrective Action and Preventive Actions (CAPA, corrective and preventive measures) in our quality system.
How does the entry control of the artwork take place?
Artwork, excluding the text, is meticulously checked for deviations from the approved and signed PDF. Any deviations will be discussed with you. The text remains your own responsibility, but we are happy to think along with you if desired.
Do you work with internal audits?
Yes, we work with an annual system of regular internal audits.
What is the minimum quantity I can order?
For most products this is about 15 kg, but there are two exceptions:
- For coated products this is at least 75 kg
- For products to be sachetted, this is a minimum of 25 kg
Which dosage forms can SoliPharma offer?
SoliPharma is specialized in dry dosage forms. Our expertise lies in tablets (coated and uncoated), chewable tablets, capsules, granulates, powders and dragées. We will work with you to determine which dosage form is most suitable for your formulation.
Can SoliPharma also pack products?
SoliPharma has the option of blister, carton, sachet and bottle. It is also possible to purchase products in bulk; Bag-In-Box or Bag-In-Drum.
Can you take care of the complete process from purchase to delivery?
Yes, because we can and would like to provide you with full service. From the selection and purchase of raw materials and packaging materials, via production and packaging to delivery in ready-to-use consumer packaging. In practice, full service appears to be best integrated into the other business processes, so that timely delivery of good quality end products in consumer packaging is the most reliable.
Can I supply raw materials and / or packaging materials myself?
There is that possibility, but it is often more practical and convenient to have it taken care of by SoliPharma. We are happy to unburden you, so that you can focus on your market. In practice it has turned out that outsourcing to us offers the best guarantee of timely delivery. This is because the handling can then be integrated into our standard business processes.
What is the delivery time?
Because SoliPharma works with a very large diversity of raw materials, we do not have fixed delivery times. Delivery times are issued on the basis of available capacity, availability of (unique) raw materials and forecasts already supplied. To guarantee high delivery reliability, we can work out a rolling forecast together. This assures you of reserved capacity, fast delivery and low own stock.
How long will it take to receive a quote?
SoliPharma strives to send you a quote within fourteen days. This partly depends on the availability of the desired ingredients. If an ingredient is not part of our stock and it must be sourced, we can usually provide you with a price indication within fourteen days. We then take care of the compliance checks as soon as you agree with the price indication.
How soon can I get a price indication?
We provide a price indication based on raw materials included in our range within a week. If one or more ingredients are not part of our standard range of raw materials, a price indication can in most cases be issued within fourteen days.
How long is a quote valid?
A quotation is valid for two months after the date of issue.
Can I get an origin declaration from you for the ingredients used?
Yes, we provide such declarations on request.
Does SoliPharma have a written complaints procedure?
Yes, we do.
Do you have a recall procedure?
Yes, we have an effective recall procedure that is tested at least once a year.
How long are retained samples stored?
At least as long as the shelf life of the final product.
Do you have product liability insurance?
yes we have product liability insurance. Consequential damage is not covered therein (see also our general delivery conditions)
Can you also supply organic products?
We can certainly supply organic products. Our X-Selection database of active raw materials can be a good help. However, we do not yet have a SKAL certificate.
Can you provide the artwork?
We certainly can. SoliPharma will be happy to develop your ideas. However, your organization remains legally responsible for the text on the packaging, the label and the package leaflet.