Quality & documents
Documents first. Then a price.
Your QA team decides whether a new source is viable. We do the groundwork before you spend time on it: we check the manufacturer, assemble the documents and review them against EU requirements and your specification.
How we check
Four layers of checking before anything ships
- 01
Manufacturer
- Valid CEP or ASMF and its holder
- EU GMP certificate or inspection record in EudraGMDP
- Food-safety or ISO certificates verified in the issuing body’s register
- Questionnaire and, where required, an audit
- 02
Documents
- Specification against Ph. Eur., USP or your own
- Written Confirmation for active substances
- Nitrosamine, ICH Q3D, ICH Q3C and TSE/BSE statements
- SDS and REACH route for chemicals
- 03
Batch
- Batch CoA reviewed against the agreed specification
- Botanicals: ethylene oxide, pesticides, heavy metals in an accredited lab
- Retained samples policy agreed with you
- 04
Supply chain
- Original manufacturer packaging, no repacking of active substances
- Transport conditions matched to the product
- EU import, customs and border controls documented
- Change control and notification in writing
Document matrix
What you can expect, by product group
● Standard○ Where applicable
| APIs | Botanicals | Chemicals | Private label | |
|---|---|---|---|---|
| CEP or ASMF with letter of access | Standard | — | — | — |
| EU GMP certificate / inspection record | Standard | — | — | — |
| Written Confirmation (CDSCO) | Standard | — | — | — |
| Specification and batch CoA | Standard | Standard | Standard | Standard |
| Nitrosamine risk assessment | Standard | — | — | — |
| ICH Q3D / Q3C / TSE-BSE statements | Standard | Where applicable | — | Where applicable |
| Ethylene oxide & 2-chloroethanol results | — | Standard | — | Where applicable |
| Pesticides, heavy metals, contaminants | — | Standard | — | Standard |
| Food-safety certificate of the manufacturer | — | Standard | — | Standard |
| Safety data sheet (EU format) | Where applicable | Where applicable | Standard | — |
| REACH registration information | — | Where applicable | Standard | — |
| Label, claims and GIS notification review | — | — | — | Standard |
Licences & status
What is in place today
Green Future Clinics is a young company. Active substances will be imported through a licensed Polish partner (agreement in negotiation) while we prepare our own entry in the register of active-substance importers kept by the Chief Pharmaceutical Inspectorate (GIF), with a quality system that follows EU GDP for active substances. We update this list with dates as each step is completed.
Last reviewed:
- 01Sourcing network in IndiaActive
Through Sudarshan Pharma Industries; we shortlist manufacturers that already supply the EU.
- 02Documentation reviewActive
CEP/ASMF, GMP, CoA and Written Confirmation checked before quotation.
- 03Licensed Polish partner for active substancesIn progress
Agreement in negotiation. Imports of active substances will run under the partner’s GIF registration.
- 04Own GIF registration as active-substance importerIn progress
In preparation, with a quality system that follows EU GDP for active substances. We publish the filing date here.
- 05Accredited laboratory partnerIn progress
Selection in progress. Until signed, we require results from the manufacturer’s ISO/IEC 17025-accredited laboratory.
- 06Packaging & labelling in PoznańPlanned
Planned for private-label supplements.
Claims policy
What you will never read on our site
- 01
That we manufacture. We do not; we source from manufacturers and say who they are in the document package.
- 02
Certificates we cannot show. If a certificate is mentioned, it has a number, an issuing body and a date.
- 03
Health claims for food-supplement ingredients beyond those authorised in the EU register.
- 04
Promotion of prescription medicines to the public. Technical data on Rx active substances are for licensed manufacturers.
- 05
Price promises we cannot back with landed-cost numbers.
FAQ
Questions from QA teams
Are you registered with GIF as an active-substance importer?
Not yet. Our GIF registration is in preparation; until it is granted, active substances will be imported by a licensed Polish partner named in the offer. The status list on this page is dated and updated.
Will I know who the manufacturer is?
Yes. The document package names the manufacturer and site, with its CEP or ASMF and EU GMP inspection record. You can audit the manufacturer.
Do you test batches in the EU?
For botanicals we require accredited-laboratory results for ethylene oxide, pesticides and heavy metals per batch. For APIs, release testing is done by the manufacturer and by your QC under your marketing authorisation; additional testing can be arranged.
How fast can I get documents?
For core-range ingredients we usually send the first package soon after an enquiry with your company details. Some documents (for example the applicant’s part of an ASMF) require a confidentiality agreement.
Ask for the document package.
Name the ingredient and the documents your QA needs. Some documents require a confidentiality agreement.
Or write to hello@gfclinics.pl