Quality is paramount in the pharmaceutical industry, as people’s lives are directly dependent on the quality of medicines given to them for the treatment of diseases. This highlights how important it is to have a reliable partner for the testing and certification of pharmaceutical products and their ingredients.
Pharmaceutical Testing Services:
Confirming that all aspects of your pharmaceutical production process are uncontaminated is vital for meeting your regulatory obligations and ensuring that your products are fit for the market. The impurities may include compounds removed or leached during manufacture and storage from container closure systems as well as synthetic, degradation-related, and elemental impurities.
You need exact results, dependable service, and quick turnarounds when it comes to quality analytical controls for raw materials, APIs, finished products, and packaging materials. Our advanced, well-equipped labs provide thorough quality control testing services in accordance with your requirements and the pharmacopoeia (such as EP, USP, BP, and JP). With our extensive network of laboratories, you can take advantage of local support, quick turnaround times, and superior analytical testing services. These services are offered as per prevailing industry standards. We offer these services for the following products:
- Raw materials
- Active pharmaceutical ingredients (API’s)
- Bulk drugs
- Finished products
- Personal care products
- Packaging materials
Our pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertains to the quality control laboratory and product testing.
- Compliance with country-specific requirements in the United States, Europe, and the Rest of the World
- Compliance with Indian pharmaceutical regulatory requirements
- Analytical method development on LCMS, HPLC, GC, UV, and chemical analysis with all traceability
- Analytical method validation as per ICH guidelines on LCMS, HPLC, GC, UV, and chemicals with all traceability
- Verification of analytical methods on LCMS, HPLC, GC, UV, and chemical systems with full traceability
- Analyses of pharmaceutical raw materials and products
- Analysis of all nitrosamine impurities
- Qualification of working standards
- Determination of nitrosamine by LCMS
- Determination of all elements by ICPMS as per ICH Q3D
- Assay determination by chemical, UV, and chromatography in accordance with national and international standards
- Determination of related substances (impurities) in raw materials and products by chromatography as per ICH Q3
- Determination of Particle Size by Malvern
- Determination of Extractable and Leachable
- Chemicals by DSC
- Chemical, UV, and chromatographic dissolution determination in accordance with national and international standards
- Chemical, UV, and chromatographic methods are used to determine the uniformity of content in accordance with national and international standards.
- Disintegration tests of empty capsules, capsules, tablets, boluses, and non-boluses according to national and international standards
- Determination of water content by Karl Fischer
- Determination of LOD at 60°C and 105°C
- Determination of Ash and Sulfate Ash
- Determination of Loss of Ignition
- Determination of pH for raw material, suspension, syrup, parenteral preparation, and ophthalmic solution
- Determination of optical rotation and specific optical rotation as per national and international standards
- Determination of limit tests by colorimetry as per national and international standards
- Determination of the friability of uncoated tablets, coated and uncoated, as per national and international standards
- Description of raw material, suspension, syrup, tablet, capsule, granules, pellets, cream, parenteral preparation, and ointment as per national and international standard
- Identification of raw material, suspension, syrup, tablet, capsule, granules, pellets, cream, parenteral preparation, ointment, etc. by chemical means (UV, FTIR, ATR, chromatography, etc.), as per national and international standards
- Solubility of a product as per national and international standard
- Weight Variation of Tablets and Capsules
- Delivered volume of a product as per national and international standards
- Powder fill weight according to national and international standards
Eureka offers you in-depth training and experience in developing and validating pharmaceutical methods for raw materials, APIs, finished products, cleaning, and bioanalytical testing.
With validation, there will be a sure-shot way of determining that the selected method yields results that are reproducible, reliable, and consistent. Hence, it must also be ensured that the procedure to be used is defined with absolute clarity.
Among the method validation protocols, it can be validated by two types of methods; pharmacopoeial and non-pharmacopoeial.
We provide the development and documentation of analytical protocols and reports for proprietary and non-proprietary test methods and manufacturing processes to assist you with pharmaceutical method development and validation processes. This is done in accordance with the ICH (Q2A, Q2B) and FDA guidelines for Notes for Guidance Validation of Analytical Procedures, Definitions and Terminology, and Validation of Analytical Procedures Methodology.
A method may need to transfer after it has been validated. Comparative testing, co-validation across two sites (lab-to-lab), full or partial revalidation, and thorough documentation are possible components of method transfer (transfer plan, protocol, and report).
Residual Contaminants and Impurities:
A wide range of analytical services is available to enable proactive risk management of the presence of pollutants and impurities in your materials and products.
Impurities can be generated or contaminate pharmaceutical products at many points during the development, manufacture, and distribution processes. They may include synthetic, degradation-related, or elemental impurities and substances extracted or leached during production and storage from container closure systems.
Our experts can accelerate the identification and mitigation of issues associated with your key starting materials or excipients, potential impacts arising from your manufacturing and cleaning processes, or changes in storage materials and transport conditions. This ensures your products remain safe right throughout the supply chain, enabling you to comply with all your regulatory and patient safety commitments.
The pharmaceutical industry is required by official bodies to demonstrate that no toxic or harmful substances migrate from packaging materials into a drug during its expected product shelf life. Similarly, in single-use systems (SUS) and other consumables used in pharmaceutical production, such as filters, tubes, connectors, and others, there is significant interest in the investigation of potential leachables that end up in the finished drug product. Leachables tests on finished container closures are performed in cGMP-compliant laboratories using ultra-trace detection technologies.
Our comprehensive analytical services include the following:
- Pharmacopeial testing based on IP, USP, BP, EP, or JP
- Testing using the client’s own or in-house methods
- Heavy metals analysis
- Method development and validation
- Quality control of raw materials and excipients
- Testing of intermediates and finished products
- Residue and Trace Analysis
- Identification of elemental impurities
- Microscopic examination
- Residual Solvent Analysis
- Stability testing
- Extractable and leachable studies
- Microbiological testing
- Sterility testing
- Test for specific microorganisms.
- Bacterial endotoxins are tested using the LAL/gel clot method
- Limit tests performed in accordance with the standardised protocol
- Preservative efficacy and antimicrobial effectiveness testing
- Bioburden testing
- MLT, BET, Bioburden, and Sterility Method Validations
- Environment monitoring in clean rooms
- Chemical disinfectant testing and cleaning studies
- Microbial identification
- Minimum Inhibitory Concentration (MIC)
- Zone of Inhibition Test (ZI)
- Cleaning validation
A wide variety of cutting-edge cGMP pharmaceutical product testing services are provided by high-performance teams with the aid of state-of-the-art technologies.
Honesty and scientific rigour are essential to ensuring that you receive fast and reliable information on which to base data-driven decisions.
We provide a full variety of cGMP pharmaceutical testing solutions that comply with global regulatory standards. Our experts are adaptable and give you extra technical support, enabling you to meet your changing business needs. Clear channels of communication ensure the integrity and correctness of every service provided.
Our assortment of solutions can be provided on a full-time basis or whenever you need extra flexibility due to a heavy workload. No matter your business, product, or sample, our priority is always to provide accurate and timely results.
Pharmaceutical drug ingredients and medicinal products are developed in a significant way due to microbiological testing. Pharmaceutical Microbiological Testing is critical for patient safety because those taking the medications may already be infected and compromised.
The microbiological characteristics of pharmaceutical components are frequently crucial to the quality of the finished product. Manufacturers are expected to measure and characterise the microbial quality of their pharmaceutical substances as well as their final drug products, according to the FDA.
Our microbiologists have extensive knowledge of using USP and other international techniques to analyse a variety of biologics and conventional pharmaceuticals. We are dedicated to giving you the key to health since we are known as the global standard for quality and integrity.
To meet regulatory requirements, our teams of microbiologists assist in determining your needs and expectations. Our technical proficiency and microbiological testing capabilities underpin our scientific methodology. With extensive method validation expertise, our team of microbiologists ensures the quality and integrity of all test results.
Our facilities are up to the rigorous engineering and sanitary standards of microbiological testing programmes. Before being processed in the production environment, Eureka Pharmaceuticals Microbiological Testing makes sure that the raw materials used to make medications meet the standard quality requirements. Additionally, our microbiologists confirm the procedures used to test completed goods and keep an eye on the air and water quality from a microbiological standpoint.
Services for Biological and Microbiological Testing
We provide pharmaceutical microbiology testing services to manufacturers of both sterile and non-sterile pharmaceutical products and substances. Our laboratories are well equipped and carry out all the required microbiological testing for the pharmaceutical industry, including:
Our biological and microbiological testing services include:
- Microbial limits tests (microbiological examination of non-sterile products)
- Total fungal and bacterial counts
- Sterility testing
- Microbial limit
- Microbial contaminant identification
- Detection of pathogens
- Antimicrobial effectiveness testing (sterile and non-sterile multi-dose forms) and microbial challenges
- Mycoplasma testing
- Antibiotic, probiotic, and vitamin assay
- Species Identification of House Organisms
- Total viable and non-viable particle count in large volumes of parenteral
- Microbiological assessment of antibiotics
- Endotoxin testing for bacteria
- Sampling and analysis of water for pharmaceutical microbiology
- Chemical disinfectant testing and cleaning studies
- Environmental monitoring
- Microbiological attribute studies
- Non-viable particulate testing