Releasing products to the global market

At Vetter, we use a broad range of analytical testing on APIs, in-process samples, semi-finished products, and finished products.

 

Batch releases are conducted using utilities, cleanrooms, and processes that are routinely monitored and audited according to cGMP requirements and FDA regulations. Our own Qualified Persons provide oversee the release process of all medications we supply to patients worldwide.

lab worker during pharmaceutical product testing
lab worker in microbiology laboratory
Tailored approach

Matching methods to your product specifications

Our comprehensive range of compendial and product specific analytical capabilities including physico-chemical, biochemical, and microbiological testing, aligns and supports optimally streamline quick-release testing of your compound.

Using those robust and proven testing methodologies, we assess a full spectrum of product attributes to verify they meet approved specifications for release – including purity, concentration, consistency, identity, safety, and more.

Our holistic testing capabilities including the following

Release testing

Microbiology

Sterility
Microbial Enumeration (MET) and Bacterial Endotoxin (BET) Testing
Low endotoxin recovery (LER)
Microbial identification
Growth promotion test
Potency assay

Physico-Chemical

Chromatography
Spectroscopy
Total organic carbon (TOC)
Organoleptic determinations
Coulometry
Tubidimetry

Bioanalytics

ID determination
Chromogenic assay
One stage coagulation assay (OSCA)
Electrophoresis
Qualitative polymerase chain reaction (qPCR)
Enzyme-linked immunosorbent assay (ELISA)
crat sampling in process controls on vial line
Quality safeguards

Comprehensive in-process controls

Our manufacturing processes are guided by a robust, end-to-end control strategy, with regular in-process testing to ensure efficient, cGMP-compliant production, high-quality outputs, and complete documentation.

All these controls are executed in accordance with the valid specification documents (SOPs, IPC specifications, manufacturing regulations, etc.), and are performed by fully trained and qualified employees using Quality Control-approved methods.

Contact person at Vetter

Connect with us

Interested in our services? Reach out to our team of experts to discuss how we can support you and your injectable product.

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