Quality control, from material to medicine
Precision in testing. Confidence in quality.
At Aspen, quality means scientific evaluation, consistency and patient safety. Quality control supports this through the sampling, inspection and testing of materials and products against approved specifications.
From incoming raw materials to finished dosage forms, testing verifies identity, strength, purity and performance, giving the evidence needed for material acceptance and product release.
From incoming materials to finished product
Testing is carried out at defined points: when materials arrive, during manufacture, before a batch is released, and over the shelf life of the product.
Raw & packaging material testing
Active ingredients, excipients and packaging components are checked against approved specifications before they are accepted for use.
Tests- Identification
- Assay
- Impurities
In-process quality checks
Checks during manufacture catch variation early and confirm the process is producing material with the required characteristics.
Tests- Blend uniformity
- Hardness
- Disintegration
Finished product analysis
Each batch is evaluated against approved specifications before a release decision is made through the authorised quality system.
Tests- Assay
- Dosage uniformity
- Dissolution
Microbiological testing
Testing is matched to the product and its intended use, as part of a wider contamination-control system.
Tests- Microbial limits
- Sterility
- Bacterial endotoxins
Stability studies
Studies track how product quality holds up over time under defined storage conditions, supporting shelf life and storage instructions.
Tests- Potency
- Degradation products
- Dissolution
Reliable results through controlled practices
The value of a laboratory result depends on the integrity of the process behind it. Effective quality control requires controlled sampling, traceable records, suitable reference standards, equipment calibration and maintenance, and documented review of results.
Unexpected or out-of-specification results require investigation through established procedures. Findings should inform appropriate corrective and preventive actions and support continuous improvement.
Quality control
Provides the testing and inspection evidence used to assess materials and products.
Quality assurance
Establishes and oversees the wider system of procedures, documentation, validation, training, investigations and quality review.
Responsibility across the product lifecycle
Quality is a responsibility carried from material selection to delivery. Our focus is on scientifically sound evaluation, clear documentation and accountable quality decisions that support confidence in the medicines we supply.
Learn more about our manufacturing partners and facilities.
Aspen Pharmaceuticals Pvt. Ltd.
Questions about our quality approach?
For information on our quality systems, testing or the standards followed by our manufacturing partners, get in touch with our team.
Contact our team