Controlled substances, EU-GMP and GDP, on Business Central.
Requirement by requirement
The table shows what each rulebook asks for and what 365Phyta does about it. "Designed to support" and "designed around" are deliberate: a system supports compliance; your quality system and your validation make you compliant.
By operation: Controlled substances, Medical cannabis, Pharmaceutical manufacturing (GMP) and Pharmaceutical distribution (GDP). In more detail: EU-GMP batch records and QP release, GACP records for medical cannabis cultivation and the Annex 11 checklist.
| Requirement | Source | What 365Phyta does |
|---|---|---|
| Controlled substances | UN Single Convention 1961 and Convention on Psychotropic Substances 1971; national law (for example BtMG and MedCanG in Germany, Decreto-Lei 15/93 and 8/2019 in Portugal) | 365Phyta Licensing, designed around both conventions and national narcotics law: licence and permit register, counterparty qualification, per-shipment import/export authorisations with balance checks, quotas, a stock book reconciled to the gram with a period close signed electronically, a destruction register with a witness who must be a different person from the one recording it, regulatory reporting and controlled-substance officer sign-offs. |
| EU-GMP Part I & II | EudraLex Volume 4 (Part I medicinal products, Part II active substances) | Specifications, sampling plans, results with OOS/OOT handling, master and executed batch records, deviations, CAPA and change as controlled records in 365Phyta Quality. |
| Annex 7 | Manufacture of herbal medicinal products | For herbal and phytopharmaceutical products, including medical cannabis: starting-material documentation carried from the cultivation or supplier record into the processing batch. |
| Annex 11 | Computerised systems | Role-based access, audit trail (section 9), electronic signatures with re-authentication (section 14) and data integrity controls. |
| Annex 15 | Qualification and validation | Equipment and line clearance records; your validation tests the system's controls, and validation support is available on request. |
| Annex 16 | Certification by a Qualified Person and batch release | QP release with electronic signature; release is blocked while deviations are open or tests are missing. |
| Annex 19 | Reference and retention samples | Reference and retention samples linked to the lot they represent. |
| 21 CFR Part 11 | US FDA rule on electronic records and signatures | Signature manifestation with name, date, time and meaning; supports Annex 11 / Part 11 requirements such as audit trails and electronic signatures. |
| GDP 2013/C 343/01 | EU Guidelines on Good Distribution Practice | 365Phyta Wholesale: customer qualification, FEFO and released-only picking, returns and recalls for wholesale to pharmacies and other licensed customers. |
| GACP | EMA guideline on good agricultural and collection practice for starting materials of herbal origin | Medical cannabis, 365Phyta Cultivation: mother plants, plant batches, inputs, harvest and post-harvest steps recorded against each plant batch, so genealogy runs from cutting to lot. |
Controlled substances
Narcotic drugs are controlled under the UN Single Convention on Narcotic Drugs of 1961 and psychotropic substances under the Convention on Psychotropic Substances of 1971; medical cannabis falls under the first. Every cross-border shipment needs an export authorisation from the exporting country and an import authorisation from the importing country, each operator needs a national licence, and quantities count against national estimates and quotas. 365Phyta Licensing checks licences on both sides of an order, tracks the balance on each authorisation and quota, and keeps a stock book that reconciles to the item ledger to the gram for any period, closed with an electronic signature. Destruction is recorded in a destruction register with a witness who must be a different person. See Controlled substances and, for the most complete use case, Medical cannabis. Country packs for Germany and Portugal are in development; details are on the country packs page. For Germany, see importing medical cannabis under the MedCanG.
Validation: who does what
Under EU-GMP Annex 11 and the ISPE GAMP 5 guide, a computerised system is validated by the regulated company for its intended use, with effort scaled to risk. No vendor can hand you a "validated system". What a vendor can do is build the controls your validation tests and help you document them.
365Phyta provides
- Audit trail, electronic signatures with re-authentication and role-based access
- Release blocks for open deviations and missing tests
- Lot and status control, holds and a full lot genealogy
- Validation support available on request
You provide
- User requirements and a risk assessment for your processes
- Installation, operational and performance qualification (IQ/OQ/PQ) in your environment
- SOPs, training and periodic review
- The final validation report and release for use
Validation support available on request: tell us what your validation plan needs.
Data integrity (ALCOA+)
Regulators expect GMP data to be attributable, legible, contemporaneous, original and accurate, and also complete, consistent, enduring and available. In practice that means:
- Attributable: every entry and signature is tied to a named user.
- Contemporaneous: records are made at the step, including on the floor through Vanguard WMS Mobile devices.
- Original and enduring: events are appended to an immutable event ledger instead of overwriting history.
- Complete and available: the lot genealogy links receipt, processing, testing, release and shipment, so an inspector's question has one answer.
FAQ
Which controlled-substance rules does 365Phyta cover?
365Phyta Licensing is designed around the UN 1961 and 1971 conventions and national narcotics law, for any narcotic or psychotropic substance. It keeps licence and permit registers, counterparty qualification, per-shipment import and export authorisations, quotas, a stock book that reconciles to the item ledger to the gram with a signed period close, and a witnessed destruction register. Country packs for Germany (BfArM) and Portugal (INFARMED) are in development; more country packs are planned.
Can a software vendor sell a validated system?
No. Under EU-GMP Annex 11 and GAMP 5, validation is performed by the regulated company for its intended use in its own environment. Validation support is available on request.
How does 365Phyta handle electronic signatures?
Signatures require re-authentication, are linked to the signed record and show who signed, when and with what meaning (for example QP certification). 365Phyta supports Annex 11 / Part 11 requirements such as audit trails and electronic signatures.
Does 365Phyta keep an audit trail?
Yes. GMP-relevant events are written to an immutable event ledger with the user, date and time, designed to support the audit-trail requirements of Annex 11 section 9 and ALCOA+ data integrity.
Sources
- UNODC, Single Convention on Narcotic Drugs, 1961.
- UNODC, Convention on Psychotropic Substances, 1971.
- European Commission, EudraLex Volume 4: EU Guidelines for Good Manufacturing Practice (Part I, Part II and Annexes).
- Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01).
- US FDA, 21 CFR Part 11: Electronic records; electronic signatures.
- EMA, Guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin.
See the stock book close in a demo
30 minutes with a Business Central consultant who knows narcotics law and GMP, from stock book to QP e-signature.