What does Solupharm’s in-house analytics deliver?
As a CDMO, Solupharm provides analytical testing beyond mere filling – a core feature that distinguishes a Contract Development and Manufacturing Organization from a classic contract manufacturer. Analytics is carried out in the company’s own laboratory and covers the full testing scope for sterile parenterals.
Key statement
Comprehensive QC analytics in accordance with Ph. Eur., USP and JP – physicochemical, microbiological and instrumental. Own laboratory of approx. 400 m² (the laboratory area is being expanded as part of the Mission 2029 project).
| Feature | Characteristic at Solupharm |
|---|---|
| Testing standards | European Pharmacopoeia (Ph. Eur.), United States Pharmacopeia (USP), Japanese Pharmacopoeia (JP) |
| Testing areas | Physicochemical, microbiological and instrumental analytics |
| Laboratory | Own laboratory of approx. 400 m² (Mission 2029 expansion to a larger area) |
| Integration | Incoming, in-process and final controls as well as batch release from a single source |
| Regulatory | GMP-compliant in accordance with EU-GMP, FDA cGMP, ANVISA and EAEU; methods per ICH guidelines |
Physicochemical, microbiological and instrumental analytics
The testing scope covers the quality attributes relevant to sterile parenterals. The specific selection of methods depends on the active ingredient, formulation and marketing authorisation requirements.
Physicochemical analytics
Determination of physical and chemical product parameters – such as identity and content of the active ingredient, related substances and purity, as well as product-specific parameters such as pH value and fill volume. The basis is the monographs and general methods of the pharmacopoeias.
Microbiological analytics
Central for sterile parenterals: testing for sterility, determination of bacterial endotoxins as well as microbiological environmental and water monitoring. These tests ensure the microbiological quality required for injectables and infusion solutions.
Instrumental analytics
Instrumental testing methods in accordance with Ph. Eur., USP and JP for the identification and quantification of active ingredients and accompanying substances. The methods are validated and reconciled between development and routine QC as part of method transfer.
Incoming inspection and release of materials
Analytics begins before production. Incoming materials are tested and only transferred to manufacturing after release.
1
Material receipt
Active ingredient, excipients, primary packaging (glass ampoules, glass vials, stoppers, crimp caps) and secondary packaging (labels, package inserts, folding cartons) are inspected on receipt and released in the in-house analytics.
2
Water for injection (WFI)
WFI is produced internally and continuously monitored – as carrier solution or solvent for sterile parenterals.
3
Release
Formulation and filling start only after analytical release of the materials. This ensures that only specification-compliant starting materials are processed.
In-process and final controls per batch
During and after manufacturing, accompanying controls ensure the consistent quality of every batch.
- Ongoing in-process controls during compounding, sterile filtration and filling
- 100% inspection of filled containers for particles, cosmetics and fill volume – automated or combined automated-visual
- Leak testing of sealed containers; for glass ampoules additionally by high-voltage leak detection (HVLD)
- Analytical batch testing as the basis for batch certification in accordance with EU-GMP
Batch release from a single source
Because incoming inspection, in-process controls and final controls are performed in the same house, interfaces and release times are reduced. Analytical batch testing forms the basis for batch certification in accordance with EU-GMP.
Stability studies and method development
Analytics is closely interlinked with pharmaceutical development (galenics). Solupharm accompanies products from pre-formulation to the validation batch.
| Service | Scope |
|---|---|
| Formulation development | Development of stable, sterile formulations aligned with the active-ingredient profile |
| Stability studies | Investigation of product stability over the shelf life as the basis for expiry and storage conditions |
| Scale-up | Transfer from laboratory to production scale |
| Method transfer | Transfer and reconciliation of analytical methods between development and routine QC |
CMC section and regulatory support
The analytical data feeds into the marketing authorisation documentation. Solupharm supports the client in preparing the chemistry-manufacturing-controls part.
CMC support
Support and provision of documents for preparing the CMC section (Module 3.2.P per ICH-CTD format) for marketing authorisation dossiers as well as accompaniment of authority inspections. The marketing authorisation dossier remains entirely with the client.
The same analytics and quality structures ensure the testing of clinical trial samples (IMPs) and commercial batches.
Frequently asked questions about in-house analytics
To which standards does Solupharm’s analytics test?
The in-house QC analytics tests in accordance with the leading pharmacopoeias: European Pharmacopoeia (Ph. Eur.), United States Pharmacopeia (USP) and Japanese Pharmacopoeia (JP). Testing is GMP-compliant in accordance with EU-GMP, FDA cGMP, ANVISA and EAEU.
Which analytics areas does Solupharm cover?
In-house analytics comprises physicochemical, microbiological and instrumental testing. This includes, among others, identity and content, related substances and – central for sterile parenterals – testing for sterility and bacterial endotoxins.
Is analytics performed in-house?
Yes. Solupharm operates its own laboratory of around 400 m² (the area is being expanded as part of the Mission 2029 project). Incoming inspection, in-process controls, final controls and batch release are performed from a single source, which reduces interfaces and release times.
Does Solupharm support marketing authorisation?
Yes. Solupharm supports the preparation of the CMC section (Module 3.2.P per ICH-CTD format) for marketing authorisation dossiers and accompanies authority inspections. The marketing authorisation dossier remains entirely with the client.
Are clinical trial samples also tested analytically?
Yes. The same analytics and quality structures ensure the testing of clinical trial samples (IMPs) and commercial batches – accompanied by formulation development, stability studies and method transfer.
Sources, standards and regulatory references
- Ph. Eur. – European Pharmacopoeia (general methods and monographs)
- USP – United States Pharmacopeia
- JP – Japanese Pharmacopoeia
- EU-GMP – EudraLex Volume 4 (incl. Annex 1 for sterile medicinal products)
- ICH – Q2 (method validation), Q6A, Q1A (stability) and CTD format Module 3