Category: Quality

What is a Stability Study? A stability study is the evaluation of the ability of a pharmaceutical product to remain in its quality, safety and efficacy over a period under designated environmental conditions. It is critical in the establishment of shelf life, packaging, and storage rules. The regulatory bodies demand stability data so that medicines… Continue reading What is a Stability Study

What is an Audit Trail? The accuracy, integrity and traceability of data is non-negotiable in the pharmaceutical industry. All data created in the process of drug development, manufacturing, testing, and distribution should be dependable and inaccessible.

What is Batch Record Review? Product quality and regulation standards are of paramount importance in the pharmaceutical manufacturing process. The Batch Record Review (BRR) is one of the most vital aspects that guarantee this compliance. It is a documented verification procedure that either validates or disapproves a drug product upon release that has been produced… Continue reading What is Batch Record Review

What is Qualified Person (QP)? The Qualified Person (QP) is very important in pharmaceutical manufacturing as it ensures that medicinal products adhere to all required quality and regulatory specifications before being released in the market. Pharmaceutical regulations in most countries and especially in the European Union require this role and it is essential to the… Continue reading What is Qualified Person (QP)

GMP Audit Best Practices: Ensuring Compliance and Quality with Masuu Global Why GMP Audits Matter: Good Manufacturing Practice (GMP) audits are essential in regulated industries such as pharmaceuticals, biotechnology, food, and cosmetics. They help ensure product quality, safeguard consumer safety, and meet requirements set by agencies like the FDA, EMA, and other regulatory bodies.

In any successful business—especially in industries like pharmaceuticals, biotechnology, manufacturing, logistics, and food processing—consistency and compliance are key. One of the most effective tools to ensure both is the use of SOPs, or Standard Operating Procedure. At Masuu global, we assist organizations to develop and implement effective SOPs that can enhance their operations and orient… Continue reading What is an Standard Operating Procedure (SOP)

In today’s fast-evolving digital landscape, businesses increasingly rely on complex computer systems to manage critical operations, especially in regulated sectors like pharmaceuticals, biotechnology, medical devices, and manufacturing.

Maintaining high standards for product safety and quality is a legal necessity for the food, pharmaceutical, cosmetic, and medical device industries. A good manufacturing practice audit, or GMP audit, is a comprehensive examination procedure intended to make sure that a business’s production procedures comply with global regulatory requirements.

An Analysis of GxP Audit Procedures and FDA Inspection Readiness Strategies GxP audits are necessary in the pharmaceutical industry to ensure that operations comply with global regulatory standards, especially those established by the U.S. Understanding audit procedures and inspection readiness is essential for organizations involved in or supporting pharmaceutical manufacturing and R&D to ensure compliance… Continue reading An Analysis of GxP Audit Procedures and FDA Inspection Readiness Strategies

The Importance of GMP Audits in Ensuring Product Safety and Quality Regardless of the industry, maintaining high standards of quality and assuring product safety is paramount to perform successfully, make profit and avoid mistakes. In the pharmaceutical sector protecting the patient’s safety and credibility requires performing Good Manufacturing Practices (GMP) audits. GMP custom made audits… Continue reading The Importance of GMP Audits in Ensuring Product Safety and Quality