MeridaleQuality
Quality and GMPNothing leaves until every result is in.
Our quality system covers every batch from incoming material to release: what we test, the limits it must meet, who signs, and the records we keep.
Five stations, every batch.
- Receive
Every incoming material quarantined and tested before use.
- Make
Made to the master batch record in classified suites.
- Test
Chemistry and microbiology in our own laboratory.
- Review
Every result checked against its limit by QA.
- Release
Signed release; samples and records retained past expiry.
Verify a batch certificate.
Enter the batch number printed on the pack or the delivery docket to see its release record.
The batch's release record appears here.
Every result, inside its limits.
The limits a typical oral liquid must meet, and where batch MD-2610-118 landed. Illustrative values.
| Test | Method | Limit | Result | Within specification |
|---|---|---|---|---|
| Assay, component A | HPLC-UV | 90.0–110.0 % | 101.4 % | |
| Assay, component B | HPLC-UV | 90.0–110.0 % | 98.2 % | |
| Related substances | HPLC-UV | ≤ 2.0 % | 0.38 % | |
| Microbial count (TAMC) | Ph. Eur. 2.6.12 | ≤ 10³ cfu/g | < 10 | |
| Fill volume | Gravimetric | 25.0–26.0 mL | 25.4 mL |
Air that only flows one way.
Rooms step down in pressure from the manufacturing suite to the corridor, so air always moves from cleaner to less clean. Differentials, temperatures and particle counts are logged every minute.
Hover or tab to a room for its grade and pressure.
Checked by others, on a schedule.
| Licence or certificate | Issued by | Scope | Valid to |
|---|---|---|---|
| Manufacturing licence [placeholder] | TGA | Manufacture, testing and release of medicines | Ongoing |
| GMP inspection, last closed | TGA | Whole site | Sep 2026 |
| Laboratory accreditation [placeholder] | NATA | Chemical and microbiological testing | Mar 2028 |
| Quality management | ISO 9001 [placeholder] | Corporate quality system | Jun 2027 |