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What Is Pharmaceutical Testing? Role in Drug Quality and Safety
Pharmaceutical testing refers to the analytical methods used to evaluate the quality, purity, identity, and microbiological status of drug substances and finished drug products. These evaluations establish whether materials meet predefined specifications and whether manufacturing processes remain in control under cGMP requirements. Pharmaceutical testing operates alongside—but is distinct from—clinical development. While clinical trials examine safety and efficacy in human populations, pharmaceutical testing focuses ... What Is Pharmaceutical Testing? Role in Drug Quality and Safety
What Is Microbiology Testing? Importance and Applications
Microbiology testing encompasses the analytical approaches used to examine the microbial content of materials, utilities, and controlled environments. These evaluations determine whether organisms are present, quantify microbial loads when required, and characterize isolates recovered during routine monitoring or investigations. The resulting data form part of the evidence used to assess whether manufacturing processes remain within their intended microbial control ranges. In ... What Is Microbiology Testing? Importance and Applications
What Is Endotoxin Testing, and Why Does It Matter in Regulated Manufacturing?
Endotoxin testing is a core component of microbial quality control for parenteral drugs, implantable and blood-contacting medical devices, and high-purity water systems. Endotoxins—lipopolysaccharides found in the outer membranes of Gram-negative bacteria—are potent pyrogens and must be controlled at levels defined by compendial and regulatory requirements. In cGMP environments, endotoxin testing helps confirm that materials, processes, and finished products meet ... What Is Endotoxin Testing, and Why Does It Matter in Regulated Manufacturing?
What Is Stability Testing in Pharmaceutical Products?
Stability testing evaluates how a drug substance or drug product performs over time when exposed to defined environmental conditions. These studies generate the data used to establish shelf life, justify labeled storage recommendations, and determine whether a product maintains its quality attributes throughout its lifecycle. Regulatory expectations from the FDA and the International Council for ... What Is Stability Testing in Pharmaceutical Products?
Understanding Microbial Identification
Microbial identification is the process of determining the identity of microorganisms present in a sample, typically at the genus or species level. In pharmaceutical, biopharmaceutical, and medical device manufacturing, identification supports contamination investigations, environmental monitoring programs, raw material evaluation, and overall microbial control strategies. These activities help organizations understand the significance of recovered isolates and assess whether ... Understanding Microbial Identification
Guide to Sterility Testing for Pharmaceuticals
Sterility testing is a required component of pharmaceutical and medical device manufacturing, supporting the release of sterile products and compliance with regulatory expectations. In regulated environments, sterility is statistically inferred rather than proven absolutely. Compendial sterility tests are therefore conducted alongside validated sterilization processes and controlled manufacturing conditions to assess whether products meet the standards defined for sterile ... Guide to Sterility Testing for Pharmaceuticals
What Is Analytical Development in Pharmaceuticals?
Analytical development sets the framework for how a drug substance and product will be assessed throughout its lifecycle. Methods are designed and validated to meet expectations from the FDA, EMA, and ICH, ensuring that measurements of identity, strength, purity, and stability are scientifically sound and appropriate for regulatory use. Because analytical activities integrate directly with formulation and process development, they help establish specifications, ... What Is Analytical Development in Pharmaceuticals?
How to Get FDA Approval: Navigating Regulatory Compliance
FDA approval for drugs and biologics is not a single event, but a regulated process that spans development, manufacturing, and post-market oversight. Approval decisions are based on the cumulative evaluation of scientific data, manufacturing controls, and ongoing compliance with applicable FDA requirements. For organizations developing regulated products, understanding how these elements interact helps frame regulatory ... How to Get FDA Approval: Navigating Regulatory Compliance
What Is Plasmid DNA? Understanding Its Role in Biotechnology
Plasmid DNA is a small, circular, double-stranded DNA molecule that exists independently of the main bacterial chromosome and replicates autonomously using host cellular machinery. Plasmids often carry genes that confer selective advantages—such as antibiotic resistance or metabolic capabilities—but are not required for basic cellular survival. Plasmid DNA differs from chromosomal DNA in several important ways: Functional role: Chromosomal ... What Is Plasmid DNA? Understanding Its Role in Biotechnology
What Is ISO/IEC 17025? A Guide to Laboratory Accreditation
ISO/IEC 17025 is an international standard that defines the competence requirements for testing and calibration laboratories. It is sometimes described as a “certification,” though it formally establishes laboratory accreditation based on demonstrated technical competence. Laboratories accredited to ISO/IEC 17025 operate under a quality management system designed to support impartiality, traceability, and ongoing compliance. The standard ... What Is ISO/IEC 17025? A Guide to Laboratory Accreditation
What Are Advanced Therapeutic Medicinal Products (ATMPs)?
Advanced Therapeutic Medicinal Products (ATMPs) are a class of therapies that include gene therapy, somatic cell therapy, and tissue-engineered products. Designed to repair, replace, or modify biological functions at their source, they differ from traditional medicines that primarily manage symptoms. For researchers, quality teams, and regulatory professionals, understanding how ATMPs are defined, classified, and evaluated helps support development, ... What Are Advanced Therapeutic Medicinal Products (ATMPs)?
Guide to USP ‹661› Series for Plastic Packaging
Pharmaceutical packaging directly influences the safety, stability, and overall performance of drug products. The USP <661> series defines how plastic materials and packaging systems must be evaluated to confirm that they are appropriate for pharmaceutical use. For quality, regulatory, and product development teams, the standard is a key reference for: identifying packaging-related chemical migrants, assessing how materials interact ... Guide to USP ‹661› Series for Plastic Packaging
How to Calculate Endotoxin Limits
Endotoxin contamination remains a major quality concern in pharmaceutical and medical device production. Unlike sterility testing, which verifies the absence of viable microorganisms, endotoxin testing targets pyrogenic substances that remain even after sterilization. These lipopolysaccharides are heat-stable and difficult to remove once present. For manufacturers, knowing how to calculate endotoxin limits and applying validated test methods are necessary steps to meet global regulatory expectations ... How to Calculate Endotoxin Limits
What Is Raw Material Testing? Standards for Quality Assurance
Raw material testing is the process of verifying the identity, purity, composition, and quality of materials before they are used in pharmaceutical or medical device manufacturing. In regulated environments, these evaluations confirm that incoming materials meet predefined specifications and are suitable for cGMP- or quality-system–controlled production. For pharmaceutical manufacturers, raw material testing supports: confirmation that ingredients ... What Is Raw Material Testing? Standards for Quality Assurance
What Is Gene Therapy?
Gene therapy is a treatment approach that modifies, replaces, or regulates genes within a patient’s cells to address the underlying cause of disease. Instead of targeting symptoms, these therapies work at the molecular level by: replacing a nonfunctioning or mutated gene with a functional copy, inactivating a gene that is producing harmful effects, or introducing a ... What Is Gene Therapy?
What Is Pharmaceutical Release Testing?
Pharmaceutical release testing determines whether each batch of a drug is ready for distribution. Before any product is cleared for use, it must meet defined specifications for identity, strength, purity, and overall quality — confirmed through scientifically validated laboratory analysis. For manufacturers, release testing provides the final, evidence-based confirmation that a batch performs as intended ... What Is Pharmaceutical Release Testing?
What Is Analytical Testing in Pharmaceuticals?
Analytical testing is the set of scientific procedures used to evaluate the identity, strength, purity, stability, and overall quality of pharmaceutical products. These studies confirm that every batch released to patients performs as intended — and that no harmful levels of impurities or contaminants are present. Every product on the market has analytical data behind ... What Is Analytical Testing in Pharmaceuticals?
What Is Non-Compendial Testing?
Quality teams routinely support products that move faster than pharmacopoeial standards can update. When a therapy relies on novel excipients, advanced delivery systems, or biological components, there may be no official method in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), or Japanese Pharmacopoeia (JP) to verify identity, purity, or stability. Non-compendial methods are ... What Is Non-Compendial Testing?
Sterile vs Non-Sterile Testing: Requirements for Pharmaceutical Quality
Pharmaceutical products are developed within environments that are tightly controlled to protect patient safety and maintain regulatory compliance. A key distinction in this control framework is whether a product must remain sterile—completely free of viable microorganisms—or whether it can be produced within a non-sterile environment that allows a defined and monitored microbial presence. This difference ... Sterile vs Non-Sterile Testing: Requirements for Pharmaceutical Quality
Current Good Manufacturing Practice (cGMP): Key Principles
Pharmaceutical manufacturing operates under Current Good Manufacturing Practice (cGMP) — the U.S. Food and Drug Administration (FDA) framework that governs the quality, safety, and consistency of every product released to market. These regulations require that all materials, processes, and facilities meet strict standards to protect patients from contamination, dosing errors, and substandard ingredients. Since its ... Current Good Manufacturing Practice (cGMP): Key Principles
What Is Compendial Testing?
Compendial testing verifies product quality, consistency, and compliance across all stages of pharmaceutical manufacturing. It refers to standardized laboratory procedures described in recognized pharmacopoeias such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP). Through compendial testing services, laboratories confirm that: Raw materials and APIs meet defined identity and purity ... What Is Compendial Testing?
cGMP vs GMP: Key Differences in Pharmaceutical Manufacturing
Pharmaceutical manufacturers operate under rigorous quality frameworks designed to ensure that every product reaching patients is safe, effective, and consistent. Two of the most important frameworks are Good Manufacturing Practice (GMP) and Current Good Manufacturing Practice (cGMP). While the two share the same foundation, cGMP builds on those standards through advances in technology, automation, and ... cGMP vs GMP: Key Differences in Pharmaceutical Manufacturing
Ready to Elevate Your Analytical Testing?
Explore how BA Sciences can support your analytical testing needs. We’re committed to delivering fast, reliable results backed by over 35 years of industry expertise and a passion for scientific excellence. Now is the perfect time to partner with a lab that understands your urgency, invests in cutting-edge technologies, and provides dedicated, personalized service every step of ... Ready to Elevate Your Analytical Testing?
Step Inside BA Sciences: Watch Our Facility Tour & Plan Your Visit
Have you ever visited BA Sciences? We’d love to give you an exclusive look at our facility! Let’s plan a visit to our 60,000 sq ft lab located just outside the world’s leading biotech hub. We’re continuously expanding and investing in cutting-edge technology and top talent to meet even the most complex analytical needs. Our ... Step Inside BA Sciences: Watch Our Facility Tour & Plan Your Visit