What you should know about the new ISO 80369-7 Standard
ISO 80369-7 is the newly published standard that replaces the ISO 595 series of standards. The ‘Part 7’ standard is [...]
How clean is clean? – Cleaning, sanitizing, decontaminating… are you at par with FDA guidelines?
Modern cleaning validation procedures must be implemented to prove that the equipment is reasonably free of any residue. It must be documented to be safe, causes no product quality concerns, and the process is contaminant-free in accordance with FDA, cGMPs, and USP guidelines.
Elemental Analysis from a Quality Standpoint (USP 232 & 233)
Quality Assurance Units must provide assurance that the validation process has produced the expected results as per the requirements of USP General Chapter <233> Elemental Impurities in accordance with <1225> Validation of compendial procedures
FDA Guidance on Method Validation – Part One
Method Validation effects the development and quality control testing of most products. Updated FDA guidance titled Analytical Procedures and Methods Validation for Drugs and Biologics
A Candid Look at the Contract Pharma Conference
A few months back I published a blog article on the value of attending Interphex. For the regular readers (I know there are few), you will recall that I started that article by simply stating my dista
Residual Solvents: Most Difficult and Demanding Test in the Pharmaceutical Industry
Pharmaceutical products should contain low levels of residual solvents as determined by safety data. The presence of residual solvents in pharmaceutical products needs to be determined through testing
Effective Teamwork in a GMP Laboratory Environment
Three years ago, the executive management of Whitehouse Laboratories implemented a major reorganization plan. Over the previous ten years, the company had experienced many areas of growth to include e
Navigating USP Updates
Available tools to navigate the USP flow of information that will help remain abreast of changes that may affect your organization
The Value of Pharmaceutical, Biotechnology and Science Related Internship Programs
implementing an intern program for college students specific to engineers, chemistry, biology and material science students can lead to a mutually rewarding results
The Strategic Use of Outsourcing
Contract laboratories go beyond routine laboratory work and provide the consultancy support required to meet theses ever changing regulatory developments.