Quality Control Solutions for Regulated Laboratories
Sartorius specializes in delivering innovative QC instruments and consumables for microbiological, physicochemical, and biological analyses, supporting accurate and reliable results.
With a focus on efficiency and compliance, Sartorius empowers laboratories worldwide to streamline their Quality Control (QC) processes and maintain the highest standards in product safety and potency.
Our portfolio includes products:
Consult a Pharma QC Expert Discover Different Modality Workflows
A bioanalytical QC lab conducts tests on complex biological molecules to assess their quality, purity, and safety. It employs various analytical techniques to evaluate biologics' characteristics, such as identity, potency, and stability. Virus titers are also quantified at this stage to achieve the highest safety level.
Discover our solutions:
Explore Biologics Analytical QC Solutions
Pre-analytical sample preparation QC involves quality control measures before sample analysis. It ensures accurate and consistent sample processing, including measurements, contamination checks, and adherence to protocols. By maintaining sample integrity and minimizing errors, it enhances the reliability and accuracy of laboratory analytical results.
Explore Preparation in QC Solutions
A microbiological QC lab in the pharma industry tests and monitors the microbiological quality of pharmaceutical products. It ensures they are free from pathogens, conducts sterility and microbial limit testing, and monitors the manufacturing environment for potential sources of contamination.
Explore Pharmaceutical Microbiology Solutions
Intelligent tools for microbiological contamination monitoring
Analytical label-free method for biologics lot release and in-process testing
Instruments and consumables for reliable sample preparation
Solutions for overarching regulations and qualified services
GxP-compliant lab software for data management & electronic records
Outsourced biologics testing to accelerate analytical development and lot release timelines
Ultra-High Resolution Cubis® II balances are ideal for applications in QC analytical laboratories, offering excellent weighing accuracy and compliance features. With advanced software and hardware capabilities, these balances provide flexibility, along with a software-guided cleaning process to meet routine maintenance requirements.
Download the White Paper: Use of Laboratory Balances in the Pharmaceutical Industry
Explore the Cubis® II High Resolution Balance
The Sterisart® NF System is a closed, disposable technology based on the membrane filtration method, providing a risk-free sterility testing solution for various pharmaceutical products. With numerous adapter options in combination with Sterisart® Universal Pump, the system eliminates the risk of false positive results.
Download the Sterility Testing Playbook
Shop Sterisart® Consumables
The Octet® BLI systems are used throughout biotherapeutic discovery, development, manufacturing, and quality control (QC) workflows to simplify and streamline measurement of process and product critical quality attributes (CQAs). These systems offer an excellent alternative to fluidic assays performed using time- and labor-intensive methods such as ELISA and HPLC.
Read the Guide: Increase Efficiency With Modern QC Testing
Explore the Octet® RH16 BLI System
Our products and solutions are aimed at providing full compliance and reliability to international standards and requirements like GMP, EU 2017/745 MDR, ISO 10993, ISO 13485, USP, JP and EP. From personnel training and equipment qualification to calibration and microbiological studies, we provide confident compliance for every step along your laboratory workflow.
Rapid microbial detection kits based on real-time PCR for mycoplasma, bacteria, and fungi provide highly specific, sensitive, and compliant results in only 3 hours.
Protecting the security and integrity of electronic records is essential for compliance. Cubis® II lab balances and Octet® BLI instruments include 21 CFR Part 11 software with audit trails. Ingenix Suite of lab data and fleet management software increases turnaround time (TAT) with GxP compliant audit trail and automated data transfer.
We are aware of our environmental responsibility and set high standards for protection as a matter of principle. We aim to reduce our CO2 emission intensity by ~10% per year until 2030, to continuously optimize the selection and use of materials along the value chain, and enable product and packaging circularity.
Modality
Description
Resource
The workflow-application map shows a generic monoclonal antibody (mAb) production process with analysis points for quality control testing.
Download the Brochure
QC in Cell Line Development
Simplify your development process from clone selection to working cell bank.
Download the Infographic
QC in Viral Vaccine and Viral Vector Production
Ensuring that your product is safe, effective, and pure
QC in Small Molecules Production
Explore the most important techniques used for the characterization of products
Download the Wall Chart
QC in Medical Device Manufacturing
Solutions for medical device development, manufacturing and quality control to rapidly boost your productivity
Ensure that your product is safe for consumers
CQAs in Nanomedicine Development
Characterize Lipd Nanoparticles (LNPs)
Solutions for optimized workflows and accurate results
Certified and accredited services to guarantee the longevity of your equipment and reduce equipment downtime
Get the performance you deserve for the compliance you expect
60 min topics to inform QC personnel on application, technical, and regulatory updates & market advancements
QC in the pharmaceutical industry stands for Quality Control. It is a critical function to ensure that pharmaceutical products meet the required quality standards and specifications. The QC department is responsible for testing and analyzing raw materials, in-process samples, and finished products to ensure that they meet the required quality standards. The QC team performs various tests and analyses, including physical, chemical, and microbiological tests, to ensure that the products are safe, effective, and of high quality. The QC team works closely with other departments, such as manufacturing, R&D, and regulatory affairs.
Pharma compliant refers to the status of following the regulations and guidelines set forth by government agencies such as the FDA (Food and Drug Administration), EMA (European Medicines Agency), Pharmaceuticals and Medical Devices Agency (PMDA), National Medical Products Administration (NMPA), Central Drugs Standard Control Organization (CDSCO) or other regulatory bodies. In the pharmaceutical industry, compliance is critical to ensure that products are safe, effective, and of high quality. Being pharma compliant means that a company has implemented and adheres to the necessary procedures, processes, and controls to meet regulatory requirements. This includes compliance with regulations related to product development, manufacturing, labeling, packaging, distribution, and post-market surveillance.
The pharmaceutical, biotechnology, medical device, and other regulated industries need to comply with 21 CFR Part 11. This regulation sets forth the criteria under which the FDA considers electronic records and electronic signatures to be trustworthy, reliable, and equivalent to paper records.
Instrument qualifications are extremely important in the pharma industry. They ensure that the instruments used in the manufacturing process are functioning properly and producing accurate and reliable results. This is critical in ensuring the safety and efficacy of pharmaceutical products. Instrument qualifications also help to comply with regulatory requirements and guidelines, such as those set by the FDA and other governing bodies. Without proper instrument qualifications, there is a risk of producing substandard products that could harm patients or fail to meet regulatory standards.
In regulated industries like Pharma or Medical Devices, QA (Quality Assurance) and QC (Quality Control) are two distinct but closely related functions that play crucial roles in ensuring the quality, safety, and efficacy of pharmaceutical products. These two functions work together to maintain high standards throughout the entire manufacturing and distribution process.
In essence, QA is responsible for establishing and maintaining the systems and processes that ensure consistent quality throughout the product lifecycle, while QC focuses on the testing and inspection activities that verify whether products meet the predetermined quality standards.
We recently asked customers what more they wished their high-resolution lab balance could do. What stood out from the feedback was that many balances...
Ensuring product safety is a top priority of pharmaceutical and medical device industries. One crucial aspect of this process is bioburden testing, wh...
In April 2022, the ISO 8655 guidelines made several changes to the calibration and testing requirements for pipettes. These updates affect general use...
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