Latest Insights

GxP Compliance

Shipping Validation and the Importance of the Cold Chain in the Pharmaceutical Market

What is Shipping validation under the GOOD DISTRIBUTION PRACTICE, and what is the importance of the cold chain in the pharmaceutical market.

CSV & Data Integrity

Data Integrity and Data Governance in the Quality Control Laboratory

The importance of Data Governance and Data Integrity, in maintaining paper and electronic records at the Quality Control Laboratory.

Audits

The auditor’s approach in the world: GMP and culture

Deep dive into the approach and the culture of an auditor, as per the Guidelines for auditing management systems.

Commissioning, Qualification and Validation (CQV)

Commissioning and Qualification of Laboratory Instruments

What is the purpose of the document about Commissioning and Qualification of a laboratory instruments, and how it can be implemented?

Medical Device

New Trends in Guidelines for Continuous Process Manufacturing

The importance of Continuous Manufacturing (CM) and its different approaches. The new guidelines and trends of continuous manufacturing explained.

GxP Compliance

Deviation Management

The deviation management process is a requirement and is designed to be a part of the Quality Management System (QMS) imposed by all major GMP.

GxP Compliance

Method Development in the EU

Method development as a key process to encompasses the process of establishing chemical analytical techniques.

Regulatory Affairs

European Medicines Agency Guidelines for the Environmental Risk Assessment of Veterinary Medicinal Products (VMPs)

The European Medicines Agency (EMA) has issued guidelines for the environmental risk/impact assessment (ERA or EIA) of veterinary medicinal products.

Medical Cannabis

Legislative panorama: Focus on Portugal

What is the current legislative situation in Portugal related to Medical Cannabis

Pharmacovigilance

Why Pharmacovigilance is Important for the Veterinary Surgeon and Industries?

Pharmacovigilance system for the Veterinary Industries and that the compliance to the requirements requested by the EU regulations.