GDP and Documentation

Medicinal Cannabis Quality Management System

Medical Cannabis Quality Management System Templates

Since 2006, PharmOut has been a leading provider of highly regarded and coveted Quality Management Systems (QMS) template packs. Purchasing is simple and facilitated through our online shop – a simple click here, pay …

PIC/S GMP Documentation Tips

What you need to know about PIC/S GMP Documentation
The TGA’s announcement of its intention to adopt PIC/S GMP PE 009-13 as of 31 December this year means Australian GMP manufacturers need to review their …

data integrity training course

Data Integrity Training Course GMP update

In December, I attended my absolute favourite GMP event of the year, the Medicines & Healthcare products Regulatory Agency (United Kingdom) (MHRA) GDP / GMP symposium in London, aside from having the opportunity to drop …

10 tips to improve your quality management system

Quality Management System Documents
A well written document with a comprehensive and well designed Quality Management System (QMS) can be a manager’s best friend. They are our daily guidance and instructions for our staff, the ‘go …

data-integrity

Ensuring Data Integrity Through ALCOA

The acronym ALCOA has been around since the 1990’s, is used by regulated industries as a framework for ensuring data integrity, and is key to Good Documentation Practice (GDP). ALCOA relates to data, whether …

data-integrity-blog

PDA suggest "Code of Conduct" for Data Integrity

Data Integrity
The Parenteral Drug Association (PDA) recently released a free “Points to Consider” document to members that outlines a number of key elements that would make up a “Code of Conduct” for Data Integrity …

Technology-in-the-hands

Embracing an electronic quality management system

Electronic Quality Management Systems (eQMS) have gained increasing popularity within the healthcare industry over the last decade. The following diagram shows the various processes for which management, communication and workflows can be automated via the use of an eQMS