Pharmaceutical Regulatory Compliance

INSIGHTS ON REGULATORY COMPLIANCE

Leverage Apps To Reduce Line Changeover Time From 14 Days To 3
A global biopharma leader modernized its complex equipment changeover process using an innovative platform to achieve faster execution, fewer errors, and greater visibility through digitized, validatable SOPs.
The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly
In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.
Compressed Gas Contamination: Guidelines For Control In Aseptic Manufacturing
Explore key guidelines for preserving the purity and quality of compressed gas, with an emphasis on contaminants, monitoring, and preventive maintenance practices.
Leachables Method Development, Validation And Relevant ICH References
It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

Measuring And Monitoring Environmental Surface Residues
4/1/2025

Explore techniques like visual inspection and TOC sampling to assess surface residues as well as discover the benefits and challenges of these practical methods to achieve effective residue validation.
Managing Nitrite Impurities: Supplier-Manufacturer View
12/19/2024

Examine nitrites in excipients, nitrosamine risks, regulatory considerations, analytical controls, and a case study on mitigating risks in pharmaceutical manufacturing and storage.
Application Of LC-UV/MS Workflows To Increase Efficiency
7/29/2025

Discover how LC-UV/MS workflows help overcome analytical challenges in GLP-1 analog development to streamline impurity identification and boost lab efficiency in research.
What Is The Biggest Problem With Inspector Training And Qualification?
8/25/2025

Discover how a truly blind system eliminates bias from the human inspection process, improving data accuracy and validation of automated inspection systems.
A Compact, Flexible, And Easy To Use Benchtop Mixer
11/4/2025

Compact, flexible, and easy to use, this benchtop mixer supports volumes from 100 mL to 10 L with integrated sensing options and GxP-compatible software, ideal for efficient, reproducible mixing.

Inventory Management Support For Chemicals, Process Liquids, And Buffers

Effective inventory management ensures the quality and traceability of raw materials, supports regulatory compliance, and enables operational savings. Learn how to secure your supply chain and reduce stockouts.
Compliant Storage For Chemicals, Process Liquids, And Buffers

Maintain material quality and integrity with storage facilities compliant with ISO 9001, cGMP, and GDP standards. Features include real-time temperature control and HAZ-class segregation.
The Next Generation Of The Number One Enterprise Quality Management System (QMS)

MasterControl has been delivering quality excellence for over 25 years. We continue to improve our quality management solution to meet the needs of highly regulated industries - like life sciences - as they embrace new levels of digitization and automation and require quality management practices that are more dynamic, connected and scalable.
Make Traceability A Seamless Part Of Your Operations

Take control of your production by tracking every part, assembly, and batch with precision.
Accelerate Batch Releases With Right-First-Time Execution

Enforce standardized workflows while collecting data in real time, giving you the visibility you need to prevent deviations, review exceptions, and release batches faster.