Pharma Quality Control

Testing Cell Therapy and Bioproduction Samples

Various pharmacopoeias, including the USP, specify a test for mycoplasma contamination must be performed as part of the release testing of a product manufactured in the presence of eukaryotic cells (1).

Low Endotoxin Recovery: A Comprehensive Overview for Biologic Drug Manufacturers

Endotoxin detection is an integral part of the quality control process, and LER muddles the reliability of results, which can result in risks to patient safety and noncompliance with regulations.

Embrace the Future of Microbial Detection in Cell and Gene Therapy with USP <72>

Automated growth-based methods have long been utilized to test microbial contamination across a diverse range of pharmaceutical products, including cell and gene therapy (C&GT) products. These innovative therapies are revolutionizing the treatment of life-threatening and chronic diseases, offering significant benefits to patients. Due to their short shelf life, these products must be administered promptly and tested for microbial contamination to ensure patient safety.

Digitalization and Automation of the Environmental Monitoring Process in C&GT Manufacturing GMP Facilities: Solution to Leverage QC Operational Efficiency, Compliance and Optimize Resources Allocation

Microbial Environmental Monitoring (EM) is crucial to assure patient safety. The visual end point reading of petri dishes has been used for decades without a true performance assessment. Besides, there is growing interest in EM automation technologies.

Optimizing Automated Growth-Based Methods for Faster Sterility Release Testing of Cell & Gene Therapy Products

Automated Growth-based methods are used for rapid detection of microbial contamination in pharmaceutical products such as Cell and gene therapy (CGT). For therapies on the critical path to patient treatment, every day/hour gained on release testing is crucial to accelerate delivery to patients in need.

Automated Nucleic Acid Amplification Assay for Mycoplasma Detection in Cell and Gene Therapy Products

Cell and gene therapies (C&GT) or Advanced Therapeutic Medicinal Products (ATMP) are innovative medicine developed to treat cancers, rare diseases, autoimmune disorders, and injuries. As these therapies utilize living cells, they produce a product with a short shelf life. While microbiological examination of cell-based products is critical to ensure patient safety, challenges exist to enable testing and obtaining rapid results prior to patient infusion.

3P SMART BIOBALL performance aseptic processing

Accurately Managing Your Aseptic Processing By Using The Right Culture Media: A Study On 3P® SMART PLATES and BIOBALL®

Accuracy of Environmental Monitoring (EM) is key in maintaining control and preventing contamination issues in pharma companies, and culture media plays a pivotal role in Environmental Monitoring programs. Culture media must provide accurate, reliable, and consistent results. Their ability to promote microorganisms’ growth must be demonstrated and validated throughout the shelf-life of the culture media, using different batches, and intra- and inter-batch reproducibility tests inoculating strains described in the Pharmacopoeias and pharmaceutical plant environmental isolates are recommended to be carried out.

The Future of Endotoxin Testing: USP Chapter <86> and the Shift to Recombinant Methods

For the past 50 years, the Limulus amebocyte lysate (LAL) test has served as the foundation of drug and medical device manufacturing endotoxin control. Now, however, the United States Pharmacopeia (USP) has recognized the need to transition to recombinant methods.

Why Pharmaceutical Developers Use BIOBALL^®

The intellectual properties and proprietary methodologies used in making BIOBALL® redefine what was considered as quantitative microbiology and make it simple to get precise and accurate quantitative microbiological quality controls batch after batch.

Scientific Study Summary: BIOFIRE^® Mycoplasma For Cell & Gene Therapy Samples

Two cell therapy and four bioproduction manufacturers evaluted the BIOFIRE® FILMARRAY® 2.0 — interested in the results in an easy-to-digest format? Download a one page Scientific Study Summary that details the study's objectives, outline, and conclusion!

Streamlining Pharmaceutical Quality: The Power Of Automated Environmental Monitoring

Traditional, manual methods of environmental monitoring can be subject to numeration errors as well as data traceability and integrity issues, which result in overall inefficiency. Want to uncover how automated methods outperform these traditional approaches? Download our infographic now and gain exclusive insights.

Scientific Study Summary: BIOFIRE^® Mycoplasma For Bioproduction Samples

Four bioproduction manufacturers evaluted the BIOFIRE® FILMARRAY® 2.0 system — interested in the results in an easy-to-digest format? Download a one page Scientific Study Summary that details the study's objectives, outline, and conclusion!

BIOBALL® Burkholderia cepacia Complex Strains Performance Testing for USP <60> Growth Promotion Requirements

Over the years, presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the U.S. Burkholderia cepacia is one of the most prominent objectionable microorganism associated with 102 non-sterile drug recalls from 2012 to 2019(1,2). It is an opportunistic pathogen and has a distinctive ability to overcome antimicrobial preservative systems.

From Challenge to Change: Implementing Digital and Automation Projects in Pharma

The experts Marie Jorna Bled (Test & Release Excellence Lead Director, MSD) and Alicia Ruiz Mahillo (Group Quality Microbiology Manager, COMPASS by FAMAR ) joined by Arnaud PARIS - Pharma Quality Control (Business Director, bioMérieux Pharma Quality Control) dive into the journey of implementing change, from identifying impactful problems to building a business case and convincing stakeholders.

Rapid Implementation of NAT technology for Mycoplasma with AnaBioTec & BIOFIRE® Mycoplasma

In this insightful webinar, you'll learn how rapid Nucleic Acid Amplification Techniques (NAATs), such as BIOFIRE ® Mycoplasma, can be seamlessly implemented as an alternative method for Mycoplasma detection in pharmaceutical production.

Regulatory Submission Strategy for Implementation and Validation of a New PCR-Based Technology for Mycoplasma Testing

This on-demand webinar presents the regulatory submission strategy for implementation and validation of a new PCR-based technology for mycoplasma testing of different products.

1-hour mycoplasma testing

In this 15-minute webinar you will learn how you can maximize operational efficiency and save costs with 1-hour mycoplasma results using the BIOFIRE® Mycoplasma system.

Current Status and Overview of the Rapid Microbiological Methods and Endotoxin Microbiology USP Chapters under Development

An Overview of Recent USP Bacterial Endotoxins Standards Development. Detection of bacterial endotoxins is a critical quality attribute of parenteral pharmaceuticals and medical devices. Bacterial endotoxins are cell wall components of Gram-negative bacteria, ubiquitous in nature, difficult to destroy and can cause pyrogenic responses or worse.

ATMP Manufacturing - QC Micro Phase Selection

Don't miss this webinar with our partners, the National Institute for Bioprocess Research and Training (NIBRT). This session focus on quality control (QC) microbiology in the different types of advanced therapy medicinal products (ATMP) manufacturing.

Leveraging Instrumentation to Accelerate Release Testing & Minimize Human Input

This talk will focus on the analytical testing needed for the release of cell and gene therapy products. A lot of focus has been on improvements and automation of equipment used in manufacturing of cell therapies such as bioreactors. However, to improve and speed up the release testing, this needs to be done also on the analytical side.

How to implement single temperature incubation in your EM routine?

Environmental Monitoring: Expert Discussion on the Benefits of a Single Incubation Temperature

The Environmental Monitoring program (EM) is an important quality control for the pharmaceutical manufacturing operations. The most common usage is doing sequential incubation time and temperature to maximize the range of recovery of the flora. The current practice is to start with the lower temperature (22,5°) to enhance the growth of environmental strains such as molds and to switch to the higher temperature (32,5°C) to recover human skin microorganisms.

BIOBALL^® 3-Part Webinar Series

In this three-part webinar series, you’ll learn about BIOBALL® from industry experts Dr. Megha Bajaj and Dr. Tony Cundell. Discover BIOBALL® best practices, applications in non-sterile product testing methods, our in-house Isolate service, and more.

How can the latest regulatory advances in endotoxin testing support your green agenda?

This webinar delves into the ground-breaking developments in synthetic Bacterial Endotoxin Test (BET) methods, as well as the implications of the new USP Chapter <86> for Endotoxin Testing.

rFC: from scientific breakthrough to implementation

The detection of Bacterial Endotoxins in parenteral pharmaceuticals and medical devices is critical to patient safety and has traditionally relied on the Limulus Amebocyte Lysate (LAL) method. However, with the introduction of recombinant Factor C (rFC) and the adoption of USP Chapter <86>, the industry is taking a major step towards reducing the reliance on animal-derived materials while simplifying and modernizing endotoxin testing.

State Of The Art Automation For Endotoxin Testing

They say “A rising tide lifts all boats” and this is true for advances in automation as applied to various analytical test methods. Have you checked the state of automation capabilities recently? Read the white paper to learn more.

Suitability of a Single Incubation Temperature for Environmental Monitoring Programs

This white paper discusses the challenges of one media/one temperature incubation, with a real case study and evaluates the sustainability of a single incubation temperature strategy for Environmental Monitoring.

Easy 1 Hour Mycoplasma Detection in Cell Therapy Samples

Various pharmacopoeias, including the USP, specify a test for mycoplasma contamination must be performed as part of the release testing of a product manufactured in the presence of eukaryotic cells (1).

BIOBALL® Burkholderia cepacia Complex Strains Performance Testing for USP <60> Growth Promotion Requirements

This white paper provides an evaluation of BIOBALL® MultiShot 550 Bcc range recovery levels on bioMérieux BCSA (Ref 33631) ensuring they are acceptable as per growth promotion and indicative properties testing requirements of USP <60> chapter.

Bacterial Endotoxin Testing: 10 Reasons to Choose Recombinant Factor C

Recombinant horseshoe crab Factor C (rFC) methods are the latest state-of-the-art solution for effective bacterial endotoxin testing (BET). This whitepaper reviews the advantages of Recombinant horseshoe crab Factor C (rFC) over the BET methods currently in widespread use. We compare the performance of LAL reagents with rFC, and summarize the evidence supporting our 10 reasons to choose rFC.

Detection of Small Events Environmental Monitoring Culture Media

USP chapter <1116> describes Environmental Monitoring (EM) as a key element to ensure control of aseptic processing areas. The quality of the drugs manufactured is directly linked to the capacity to minimize microbial contamination.

Adoption of rFC for bacterial endotoxin testing

With industry’s push to build a more diverse global supply chain, we find ourselves at a tipping point for the widespread adoption of alternative solutions like rFC — driven as much by industry, if not more, than regulators.

Automated nucleic acid amplification assay for mycoplasma detection in cell and gene therapy products

Cell & Gene therapies (CGT) or advanced therapeutic medicinal products (ATMPs) are innovative medicines developed to treat cancers, rare diseases, autoimmune disorders and injuries. As these therapies utilise living cells, they produce a product with a short shelf life. While microbiological examination of cell-based products is critical to ensure patient safety, challenges exist to enable testing and obtaining rapid results prior to patient infusion.

Overcoming Mycoplasma Testing Challenges in Cell and gene Therapy Manufacturing with BIOFIRE®

The BIOFIRE® Mycoplasma test is a closed-system sample-to-answer nucleic acid test that is designed to report the presence/absence of over 130 mycoplasma species in less than an hour. It requires minimal hands-on time and contains everything needed to run a molecular test in a sealed pouch.

Automated 1 Hour Mycoplasma Detection in Bioproduction

Various pharmacopoeias, including the USP, specify a test for mycoplasma contamination must be performed as part of the release testing of a product manufactured in the presence of eukaryotic cells.

Pioneering Quality Control in Biomanufacturing of Cell and Gene Therapies

Lauren Coyle, Commissioning Editor, Cell & Gene Therapy Insights, speaks with Dhruv Sareen, Executive Director at Cedars-Sinai Biomanufacturing Center, and Jonathan Rodriguez, Quality Control Manager at Cedars-Sinai Biomanufacturing Center, about the roles of in-process controls, method validation, risk management, and automation in biomanufacturing.

rapid sterility testing using bact alert 3D

How a Top 5 Pharma Company Enhances Production Efficiency through Rapid In-Process Testing

A top 5 pharmaceutical company incorporated automated, rapid sterlity testing using BACT/ALERT® 3D. Their approach was designed to detect any microbial contamination at the earliest possible opportunity and has been key in maintaining control over their production processes.

Endotoxin Testing: New Horizons with Recombinant Reagents

A comprehensive analysis of historical context, current practices, and future directions in Europe and the United States.

Harnessing the Power of CAR-T Cell Therapies Without Compromising Quality Control

Download the white paper to learn about CAR-T cell therapy, which uses a patient’s own genetically modified T cells to target and kill cancer cells.

Performance study BACT/ALERT® 3D growth promotion antimicrobial neutralization

BACT/ALERT® 3D is an effective, safe and proven solution for industrial sterility testing.

Mycoplasma Release Testing Cell and Gene Therapy Product Samples

Testing for mycoplasma contamination is a required release test for Cell & Gene Therapy (CGT) products as specified in the major pharmacopeias(1-3).

Recombinant Factor C Characterization Studies Confirm the Published Structure and Function of Manufactured rFC

With the advent of first the EU Pharmacopeial Chapter 2.6.32 (2020) and now the publication of USP Chapter <86> (2024) on the use of recombinant Factor C assays, the manufactured products supplied must meet customer confidence expectations in terms of r-Protein characterization. Both current and historical QC characterization tests are described here for ENDOZYME II. The known and therefore expected structure of the complex molecule is shown below from: Shibata et al. 2018 “Intermolecular autocatalytic activation of serine protease zymogen factor C through an active transition state responding to lipopolysaccharide” (1).

Performance validation environmental monitoring automation

Environmental Monitoring (EM) is crucial to assure patient safety. The visual end point reading of petri dishes has been used for decades without a true performance assessment. Automatization technologies are more present and improve EM practices.

Mycoplasma release test with low volume protocol: From sample to results in less than 1 hour

Improved Time-To-Detection of Slow Growers Microorganisms with an Automated Growth Based Method

Presenting data to showcase how optimization of BACT/ALERT® 3D DUAL-T incubation conditions can lead to notable improvements in time-to-detection.

Testing Cell Therapy and Bioproduction Samples

Various pharmacopoeias, including the USP, specify a test for mycoplasma contamination must be performed as part of the release testing of a product manufactured in the presence of eukaryotic cells (1).

Testing Bioproduction Samples

This poster presents results from independent studies performed by 4 bioproduction companies using the BIOFIRE® Mycoplasma system that can detect >130 species of mycoplasma. The BIOFIRE® filmarray system condenses all the steps of a conventional PCR test into an enclosed pouch and provides sample to answer in less than one hour with as little as 2 minutes of hands-on time.

Rapid Robust Mycoplasma Detection System for Release Testing of Cell and Gene Therapy Products Containing Mammalian Cells in 1-Hour

Introduce C&GT product specific protocols that allows the inclusion of mammalian cells thus aligning with the upcoming EP guideline (4) whilst providing the required level of detection (≤ 10 CFU/mL) as a Mycoplasma release test.

Mycoplasma release test with low volume protocol: From sample to results in less than 1 hour

Presenting a new Low Volume protocol that allows the inclusion of mammalian cells from high cell density products thus aligning with the upcoming EP guideline whilst providing the required level of detection (≤ 10 CFU/mL) as a mycoplasma release test.

Ultra Rapid Microbial Detection in Cell and Gene Therapy Products

The SCANRDI® is an ultra-rapid alternative technology for detecting microbial contaminants in drug products. Designed to meet compendial testing standards, studies on Limit of Detection (LoD) and Equivalency have been performed with a focus on species listed by the Pharmacopeias microorganisms. The Most Probable Number (MPN) was used to demonstrate that the LoD of the SCANRDI® CELL-BURST is not significantly different from the LoD of a traditional plate counting method on 10 compendial strains.

Champion Sustainability: The 3R Revolution in Endotoxin Testing

The 3Rs principle has resonated with the pharmaceutical industry as an ethical warrant of animal welfare since 1959. It is increasingly associated with the so-called 3Rs initiatives related to larger sustainability initiatives such as reducing waste and reusing and recycling resources and products. Those new 3Rs were agreed upon at the G8 Sea Island Summit in June 2004 as a new G8 initiative. The use of rFC meets several criteria of the 3Rs, including conservation, supply chain assurance, waste reduction, and animal welfare as well as a platform for test modernization.

Low Endotoxin Recovery (LER) and Biologic Drugs

Lets explore the critical importance of understanding endotoxin masking phenomenon and overcoming the Low Endotoxin Recovery (LER) challenges. In this article you’ll learn how innovative detection methods and protocols like Hold Time Studies (HTS) can help manufacturers enhance product safety and quality standards.

Discover the Future of Endotoxin Detection with rFC and USP Chapter <86>

Endotoxin detection has long been reliant on the Limulus Amebocyte Lysate (LAL) method. The endotoxin detection landscape is evolving with the pending adoption of USP Chapter <86>. As LAL once eliminated the need for the rabbit test for the sake of scientific utility, recombinant Factor C (rFC) is becoming the new endotoxin test standard.

Solving the Endotoxin Detection Challenge for Difficult Samples

In the pharmaceutical industry, customers dealing with challenging products, particularly those in the cell and gene therapy sector, confront unique hurdles when it comes to ensuring product safety. This article explores the unique challenges faced by these customers in endotoxin testing and introduces our innovative solutions to address these challenges.

eBook: Your Quick Guide To Better Endotoxin Testing

Most new users of Limulus-based tests want to review basic knowledge around endotoxin and endotoxin detection, while more experienced users want to review the practical aspects of testing with an eye toward meeting ever-changing regulatory expectations. They also want to generate laboratory dialog as to how to apply basic principles and “best practices” to increasingly complex tasks including method development, verification, validation and the routine testing of various drug types. This material can also serve as a supplement to a user’s basic endotoxin training.

Embrace rFC for Lab Transformation

Endotoxin detection is not just a regulatory requirement; it's a critical factor in ensuring pharmaceutical safety. It's time to discover the transformative power of Recombinant Factor C (rFC) and its journey from being an alternative assay to becoming a compendial method.

Data Integrity Management and Risk Mitigation Made Simple

The standards for proving data integrity have gotten stricter. Today, regulatory organizations from all over the world, such as the FDA, EMA, and PDMA, conduct audits more frequently, in a more extensive way, and observations are becoming more frequent. They demand that data is accurate and reliable. It’s in the best interest of pharmaceutical companies to design flexible and risk-based strategies to ensure data integrity.

ENDOZYME_II_ GO STRIPES - ENDOTOXIN TESTING - Laboratory - Pharma Quality Control - Industrial Applications

A Step-by-Step Approach to Effective Endotoxin Testing

An endotoxin test involves several critical steps to ensure accurate and reliable results. Here are the 10 key elements of an endotoxin test.

The Hunt for the Missing Endotoxin

This white paper explores the causes and impact of low endotoxin recovery (LER) and presents solutions, including guidance on in-house protocol development, outsourcing considerations, and the use of the ENDO-RS® de-masking tool kit. It also features expert insights from Dr. Christian Faderl on how pharmaceutical manufacturers can effectively address masked endotoxins.

Interview with Pr. Ding, Pioneer in rFC endotoxin testing

Celebrating innovation with Professor Ding: A pioneer in sustainable endotoxin testing

Professor Jeak Ling Ding is a world-renowned pioneer in the field of molecular biotechnology. We spoke with Professor Ding to learn more about her career defining breakthrough to genetically engineer recombinant Factor C, and the importance of creating a sustainable and ethical alternative to replace traditional methods of endotoxin testing.

New Standardized Methodology to Evaluate Environmental Monitoring Plates Inspection Using an Automated System

To efficiently control the quality of pharmaceutical products, manufacturers must monitor for potential microbial contaminants. This is typically performed using irradiated culture media in Petri plates throughout the production process, especially within clean rooms, isolators and controlled production environments.

Image Whitepaper - APR Whitepaper_Automated Methods for Environmental Control (EM)

A Recognized Rapid Microbiological Method for Cell & Gene Therapy Products: Regulation & Industrial Application

This white paper details how innovative microbiological technologies are revolutionizing sterility testing for Cell and Gene therapy products. You'll learn the validation guidelines for alternative microbiological methods and gain understanding of the regulatory evolution and acceptance of rapid microbial testing.

Automated Methods for Environmental Control (EM) - Application of Automated Microbiology for Environmental Monitoring of Clean Rooms

Optimizing the control of bioproduction processes and the environmental monitoring of the biopharmaceutical industry is key to supporting the competitiveness of companies and no longer making quality control a bottleneck in the value chain of bioproduction but rather a real added value.

Role of in-house isolates in pharmaceutical quality control

Download this application note by Dr Megha Bajaj, Global Solution Manager at bioMerieux, to discover more about: - The relevancy of in-house isolates in microbiological QC testing - The selection and implementation of in-house isolates - Common microorganisms isolated in pharma labs.

Low Endotoxin Recovery: A Mitigation Approach Case Study

This white paper discusses the Low Endotoxin Recovery (LER) phenomenon in the drug testing and mitigation approach using the ENDO-RS® kit and ENDOLISA® assay for detecting endotoxin interference. Authors Dr Christian Faderl and Kevin L. Williams detail the steps for conducting a demasking study and walk through the process, providing a comprehensive case study.

Quality Control of BACT/ALERT® Culture Media

A study was conducted using commercially prepared organisms evaluating both a comprehensive organism panel as well as a streamlined method utilizing only two organisms from the panel.

SCANSQUAD Rapid Methods - Advantages of a 4-Hour TTR

One of the more advanced technologies, SCANRDI®, can generate accurate results in a little as 4 hours or less. SCANRDI® is a solid-phase cytometry system that applies a highly sensitive, non-growth based rapid microbial method, generating results in 4 hours or less.

Validation and Implementation of a Novel, Nearly Fully Automated and Rapid PCR Based Technology Webinar

Regulatory Submission Strategy for Implementation and Validation of a New PCR-Based Technology for Mycoplasma Testing

This on-demand webinar presents the regulatory submission strategy for implementation and validation of a new PCR-based technology for mycoplasma testing of different products.

Contamination Control Challenges Webinar

Contamination Control Challenges Facing Cell Therapy Facilities

The presentation aims to provide an overview of challenges that can be faced with the knowledge that a one size fits all approach cannot be taken.

Beyond the Status Quo: Making the Case for Single Temperature Incubation

Explore the science, compliance considerations, and practical benefits of Single Temperature Incubation.

BACT/ALERT® 3D: From Alternative to Routine for Testing Cell and Gene Therapy Products

This webinar explores rapid sterility testing in Cell and Gene therapy, covering the pivotal role of rapid testing and evolving regulations. Discover why the BACT/ALERT® is the trusted choice for microbial contamination testing and optimize your processes for enhanced quality control and compliance!

From Parametric Rules to Artificial Intelligence: A New Era in Microbial Image Analysis

Machine learning, particularly deep learning, offers a powerful alternative by learning complex patterns from large datasets, enabling more accurate and adaptable classification.

From Bench to Reality: the Role of Natural Contaminations in LER Investigations

There is ongoing debate regarding the most appropriate type of endotoxin to use in Low Endotoxin Recovery (LER) Hold Time Studies. PDA Technical Report 82 (TR82) recommends Reference Standard Endotoxin (RSE) and Control Standard Endotoxin (CSE) as the primary choices.

Comparing Safety Margin Methods for USP <72> Compliance

Automated growth-based methods are often used for rapid microbial contamination detection in short shelf-life pharmaceutical products such as Cell and Gene Therapies (CGT). For such products, every hour gained on release testing is vital to patients in need.

endotoxin testing journey article thumbnail

Endotoxin Testing: A 20-Year Journey Toward Recombinant Innovation

For over 20 years now, endotoxin testing has greatly evolved to more reliable and ethical methods like recombinant Factor C. From traditional LAL methods to today's recombinant technologies, the journey has been marked by scientific breakthroughs, regulatory evolution, and a shared commitment to patient safety.

Single vs. Dual Temperature Incubation in Environmental Monitoring

Single temperature incubation is less commonly used in environmental monitoring today — but that’s starting to change. This article explores how the right strategy and tools can help your program shift to a single temperature approach for greater efficiency, simplicity, and risk reduction.

Hidden Costs in EM

Download the white paper to read insights based on extensive studies and interviews conducted with more than 50 QC managers and technicians as well as QA and production representatives.

Evaluation of VITEK® MS PRIME for identifying pharmaceutical strains in Industrial Quality Control

Microbial identification is a cornerstone of pharmaceutical industrial quality control, ensuring product safety and compliance with regulatory standards. Modern technologies like MALDI-TOF mass spectrometry offer rapid, accurate, and cost-effective species-level identification, making them ideal for routine use in industrial QC.

Application of the ENDOZYME® II Assay Range for Radiopharmaceuticals

According to Directive CEE 89/343, a radiopharmaceutical is defined as any medicinal product that contains one or more radionuclides (radioactive isotopes) intended for a medicinal purpose. These compounds play a crucial role in both diagnostic and therapeutic procedures and can be used alone or conjugated with drugs or peptide molecules. Radiopharmaceuticals are subject to stringent regulations and quality control measures to ensure their safety and efficacy.

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