Pharmaceutical Testing

Ensuring the absence of contamination in all facets of your pharmaceutical production process is crucial for meeting regulatory requirements and ensuring the suitability of your products for the market. Contaminants may encompass compounds removed or leached during manufacturing and storage from container closure systems, as well as synthetic, degradation-related, and elemental impurities.

When it comes to quality analytical controls for raw materials, APIs, finished products, and packaging materials, you require precise results, reliable service, and prompt turnarounds. Our advanced and well-equipped laboratories deliver comprehensive quality control testing services in alignment with your specifications and the pharmacopoeia standards (such as EP, USP, BP, and IP). Leveraging our extensive network of laboratories, you can benefit from local support, rapid turnaround times, and superior analytical testing services, all conducted in adherence to prevailing industry standards. These services are extended for the following products:

• Raw materials
• Excipients
• Active pharmaceutical ingredients (API’s)
• Bulk drugs
• Finished products
• Personal care products
• Packaging materials
• Containers

21-CFR COMPLIANCE

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

Method Validation:

Shreeyan Lab provides extensive training and expertise in the development and validation of pharmaceutical methods for raw materials, APIs, finished products, cleaning, and bioanalytical testing.

Validation ensures a reliable and consistent outcome, making it a foolproof method for determining the reproducibility of selected methods. It is imperative to have a clearly defined procedure to ensure accuracy.

Method validation protocols can follow two types of methods: pharmacopoeial and non-pharmacopoeial. We specialize in the development and documentation of analytical protocols and reports for both proprietary and non-proprietary test methods and manufacturing processes, aiding in pharmaceutical method development and validation. Our approach aligns with ICH (Q2A, Q2B) and FDA guidelines, covering Notes for Guidance on Validation of Analytical Procedures, Definitions and Terminology, and Validation of Analytical Procedures Methodology.

In instances where a method needs to be transferred after validation, we offer comprehensive services including comparative testing, co-validation across two sites (lab-to-lab), full or partial revalidation, and meticulous documentation as part of the method transfer process (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.

The development of pharmaceutical drug ingredients and medicinal products undergoes significant advancements through microbiological testing. Pharmaceutical Microbiological Testing is crucial for ensuring patient safety, especially considering that individuals taking medications may already be infected and compromised.

The microbiological characteristics of pharmaceutical components play a vital role in determining the quality of the final product. Manufacturers are obligated to assess and characterize the microbial quality of both their pharmaceutical substances and the end drug products.

Our microbiologists possess extensive expertise in utilizing USP and other international techniques for analyzing various biologics and conventional pharmaceuticals. Renowned as the global standard for quality and integrity, we are committed to providing the key to health.

In alignment with regulatory requirements, our teams of microbiologists collaborate to identify your specific needs and expectations. Our scientific methodology is underpinned by technical proficiency and microbiological testing capabilities. With a wealth of experience in method validation, our microbiologists ensure the quality and integrity of all test results.

Our facilities adhere to rigorous engineering and sanitary standards set for microbiological testing programs. Shreeyan Lab ensures that the raw materials used in medication production meet the standard quality requirements before processing in the production environment. Additionally, our microbiologists verify the procedures employed for testing finished goods and monitor air and water quality from a microbiological perspective.

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