Pharma QC Solutions Designed to Meet GxP Requirements
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:
- to keep microbial contamination under control
- to prepare samples that meet the lowest level of detection in your analytics
- to assess critical quality attributes (CQAs) and lot release your biologics
- to protect the integrity of your electronic records
Consult a Pharma QC Expert Discover Different Modality Workflows
Sartorius Solutions for Your Lab
Find the Right Quality Control Solution
Product Highlights
Cubis® II Ultra-High Resolution Balance
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.
- 21 CFR part 11 & EU Annex 11 Compliance following the ALCOA+ principles
- Verified results according to USP Chapter 41 across the entire weighing range
- Built-in intelligent adaptable systems to manage temperature, humidity, and air pressure changes
- Upgradeable ionizer and automated inner draft shield available post purchase
- Routine and advanced cleaning processes with documented steps to integrate cleaning into SOPs
Download the White Paper: Use of Laboratory Balances in the Pharmaceutical Industry
Sterisart® Family Consumables for Sterility Testing
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.
- Great variety of adapters for vials, blow fill seals, pre-filled-syringes, collapsible bags, and more
- Compliant to USP <71>, EP 2.6.1 and JP 4.06
- Easy aseptic sampling and supplementation of antibiotics when required for dilution, identification, or inactivation
- Patented dual-needle design with protective shield for safe and easy handling when piercing containers and transferring culture media, even with isolator gloves
Octet® Bio-Layer Interferometry (BLI) Systems
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.
- Biologics QC for ligand binding and product quantitation during lot release and in-process testing
- Label-free and fully automated with simplified workflow for direct analysis of crude samples
- GxP software and services to ensure full confidence in data integrity
- Upgradable and easy transfer of methods from research to bioanalytical QC
Pharmaceutical QC Solutions Features
Sartorius Pharmaceutical QC Solutions Offer:
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 Workflows
Explore the Quality Control Steps for Your Specific Modality
Modality | Description | Resource |
|---|---|---|
| QC in mAb Production | The workflow-application map shows a generic monoclonal antibody (mAb) production process with analysis points for quality control testing. | |
QC in Cell Line Development | Simplify your development process from clone selection to working cell bank. | |
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 | |
QC in Medical Device Manufacturing | Solutions for medical device development, manufacturing and quality control to rapidly boost your productivity | |
| QC in Cosmetics & Chemicals Production | Ensure that your product is safe for consumers | |
CQAs in Nanomedicine Development | Characterize Lipd Nanoparticles (LNPs) |
Pharmaceutical Analysis Quality Control Resources
Pharmaceutical Analysis & Quality Control FAQs
Frequently Asked Questions
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.
