| Document | What it confirms | When you get it |
|---|---|---|
| Certificate of Analysis (CoA) | What testing found in your batch, set against the limits in its specification | With every batch |
| Product specification | What the product has to be: the reference the batch is made and tested against | With every batch |
| ISO 22000 certificate | The plant runs a certified food safety management system; the scope covers manufacturing and packaging of tablets, capsules and powders | Copy with its number, on request |
| GMP certificate | Production is certified to GMP for food supplements, audited against the Food Supplements Europe guide; it is not pharmaceutical GMP | Copy with its number, on request |
| HACCP certificate | Hazards in production are analysed and controlled at critical points | Copy with its number, on request |
| Banned substance test report | The result from an accredited third-party laboratory, made out to your brand | On request |
| Halal certificate | Certification of your specific product, not of the plant as a whole | Per product, on request |
Which certificates does the plant hold?
The plant is certified to ISO 22000, GMP and HACCP, and it is registered with the US FDA as a food facility. Copies with their numbers are sent on request, so your quality team can check the certificates before the first order.
What each of the three certificates refers to:
- ISO 22000 is the international standard that sets the requirements for a food safety management system in any business in the food chain.
- HACCP, hazard analysis and critical control points, is the method inside that system. Hazards are analysed at each step of production; where control is essential, a critical control point is set, with a critical limit and monitoring.
- GMP stands for good manufacturing practice. The plant holds GMP for food supplements, audited against the Food Supplements Europe guide; it is not pharmaceutical GMP.
Separately from the three certificates, the plant is registered with the US Food and Drug Administration as a food facility.
What the scope of the certificates covers
The ISO 22000 certificate defines its scope as “Manufacturing and packaging of food supplements (tablets, capsules, powders)”. Packaging stands in that wording next to manufacturing, so for tablets and capsules the blister packing is covered by the same certificate as their manufacture. The GMP and HACCP certificates name the same three formats in their scope.
For softgels, effervescent tablets, syrups and the other formats, the certificates stand as the certificates of the site, and the format itself is not named in them. If a buyer or a registration file needs your format written into the scope, raise it before you order.
What documents come with each batch?
Each batch comes with two documents: the Certificate of Analysis and the product specification.
The specification is the reference. It sets out what the product has to be and the limits it has to meet. The CoA is the result: it reports what testing found in that particular batch, against those limits. Read side by side, the two show whether the batch matches its specification.
The standard shelf life is 24 months.
Copies of the site certificates are added on request, and a banned substance report or a halal certificate joins the file when your product needs one.
What does the blister machine record?
According to the machine documentation, the Uhlmann B 1240 that seals tablets and capsules into blisters keeps audit trails of production and of machine parameters, and its TouchControl panel restricts access by password login. The documentation lists these under traceability at machine level.
The same machine forms the pockets, fills them, seals the lid foil and cuts out each blister in one continuous pass, with platen sealing at low temperature. These are features of the machine as its documentation describes them; the full data is.
On a blister product, the expiry date is printed on the carton: either with the carton print itself or as the blisters are packed into the carton.
How an order runs from brief to shipment is on the manufacturing page.
Can I check the plant before I order?
Yes. You can visit the plant, ask for copies of the certificates with their numbers, and see a sample before you place an order. Ask for any of the three with your enquiry; enquiries are answered within 24 hours, Monday to Friday.
Can my product be tested for banned substances?
Yes, on request. The product is tested at an accredited third-party laboratory, and the report is made out to your brand.
In sports nutrition, a retailer or a team may want to see such a report before taking a product on. Because the laboratory is independent of the plant, the result does not rest on our own word. Say in your enquiry that you need it.
Is the plant halal certified?
Halal certification is arranged for the specific product rather than for the plant as a whole. Whether a product can be certified depends on its formula, so the time to raise it is your enquiry. More.
Which documents can I give an importer in Africa or the Middle East?
Three documents come from us: the Certificate of Analysis, the product specification and copies of the plant's certificates. You get the first two with every batch and the third on request.
The manufacturing group behind the plant already supplies many clients in Africa, and its main markets are the United Arab Emirates, Saudi Arabia and Lebanon. Goods ship worldwide, EXW by default, with FCA or DAP on request.
We do not take on product registration in the importing country. Where a country requires registration, the documents above are the ones such a file usually draws on; the filing itself stays with the brand owner.
Export paperwork is covered in more detail.
What your product decides
Some of what you will need is settled by the product before you choose anything. Each choice below has its cost in time or in risk.
| Your choice | What changes | What it costs you |
|---|---|---|
| A ready-made formula under your brand (white label) | The formula is already in production; the sample you see is of the existing product | The shorter production time of the two routes |
| Your own formula (private label) | A sample is developed for your formula before production | The longer production time of the two routes |
| Tablets, capsules or powders | The format is named in the scope of the certificates; for ISO 22000 the scope covers packaging as well as manufacturing | Nothing extra to check |
| Softgels, effervescent tablets, syrups, oils or another format | The certificates stand as those of the site; the format is not named in them | Risk: a buyer or a registration file that requires the format in the scope. Check before you order |
| A market that expects halal | Your product needs its own certificate | One more certificate, made out for your product alone; raise it with your enquiry |
| Sports retail or competing athletes | A banned substance test at an accredited third-party laboratory | One more report to ask for with your enquiry; it carries your brand's name |
Questions buyers ask about quality
Which certificates does HYPERPHARM's production hold?
The plant that makes HYPERPHARM products is ISO 22000, GMP and HACCP certified and registered with the US FDA as a food facility. Its GMP is GMP for food supplements, audited against the Food Supplements Europe guide; it is not pharmaceutical GMP. The three certificates name tablets, capsules and powders in their scope. Copies of the certificates with their numbers are sent to clients on request.
Does the ISO 22000 certificate cover blister packing?
For tablets and capsules, yes. The certificate's scope names packaging next to manufacturing and lists both formats, so their blister packing is covered by the same certificate as their manufacture.
How do I get the certificate numbers?
Ask for them with your enquiry. The numbers are on the certificate copies sent to clients on request, and with them your quality team can check each certificate with the body that issued it before the first order.
Does FDA registration mean the plant is FDA approved?
No. The plant holds a registration with the US Food and Drug Administration as a food facility, and a registration is a different status from an approval. Registered is the only FDA status we state for it.
Do the certificates cover softgels and effervescent tablets?
The certificates name tablets, capsules and powders in their scope. For softgels, effervescent tablets and other formats, they stand as the certificates of the site, without naming the format. If a buyer or a registration file needs the format in the scope, raise it before ordering.
What documents come with each batch?
Each batch comes with a Certificate of Analysis and its product specification. The specification sets the limits the product has to meet, and the CoA reports what testing found in that batch. Copies of the site certificates are added on request.
Can you test my supplement for banned substances?
Yes, on request. HYPERPHARM has the product tested at an accredited third-party laboratory, and the report carries your brand's name rather than ours.
Is your plant halal certified?
Not as a whole plant. A halal certificate is made out for one product, and whether that product qualifies depends on its formula. If your market needs halal, say so in your enquiry.
Will you register my product in the importing country?
No. HYPERPHARM does not take on product registration in other countries; that step stays with the brand owner. What we supply are the documents a registration or import file usually draws on: the Certificate of Analysis, the product specification and copies of the certificates.
What shelf life does a product have?
The standard shelf life of HYPERPHARM products is 24 months. On a blister product, the expiry date is printed on the carton. Plan stock, distribution and your importer's paperwork around that figure.
Can I visit the plant or see a sample before ordering?
Yes to both. A visit to the plant can be arranged, and a sample is available before you order. Ask with your enquiry; enquiries are answered within 24 hours, Monday to Friday.
What does the blister machine record?
Blisters are packed on an Uhlmann B 1240. Its machine documentation describes traceability at machine level: a TouchControl panel with password login and audit trails of production and machine parameters. The machine forms, fills, seals and cuts each blister in one pass.
Read more
Ask for the documents
Tell us the product, the market and the documents your importer or retailer has asked for. We answer within 24 hours, Monday to Friday.