QMS 101: Pharmaceutical Quality Management System

The Pharmaceutical Quality Management System (QMS) is a collection of activities and processes that improve the quality of the pharmaceutical product. It focuses on specific persons and processes involved in the production of goods and stops them from straying from quality standards like FDA 21 CFR Part 11, ISO and ICH Q10. For instance, data...

The Ultimate Guide to 21 CFR Part 11 QMS

FDA 21 CFR Part 11 is a rule that specifies how businesses that are subject to FDA regulation, such as those in the medical device, pharmaceutical, and other industries, should manage their electronic records and electronic signatures. Organizations must abide by several rules and different sets of criteria that are specific to the life science...

The Ultimate Guide to ISO 9001

The Quality Management System (QMS) doesn’t have any independent standards. It depends on other accepted standards for its definition, application, and actual execution such as ISO 9001. It is the obligation of the firm to implement the pertinent standards, which vary depending on a variety of elements, such as location, product type, and target market....

The Anatomy of a Perfect Batch Record

When it comes to manufacturing pharmaceuticals quality is critical. Following current Good Manufacturing Practices (cGMP) can help ensure that nothing goes wrong, as these practices lay the foundation for creating quality products. In most countries, cGMP is one of the conditions a company must meet to be allowed to sell its products in one jurisdiction...

Future Trends and Regulatory Challenges in Pharma

What will the near future bring to the table? To help manufacturers determine where to focus their efforts, let’s take a look at some of the most impactful technology trends and regulations in pharma today.

Top 5 Technology Trends to Prepare for in 2022

This past year is one that many would like to forget and for good reason. COVID-19 has impacted our lives in so many ways and the long-term implications are still unknown. Companies across all industries were impacted and just like when any crisis strikes – there have been those that gain and those that lose....