Pharmacist in deadly meningitis outbreak heading to trial

After watching his mother die from meningitis in a nationwide outbreak caused by contaminated steroids, Scott Shaw is determined to make sure something like that never happens again. A stiff punishment for the Massachusetts pharmacist Shaw believes is partially responsible may help, he says. “I believe as surely as I’m talking to you right now […]

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a […]

USP method transfer

USP method transfer underwent a change when the US Pharmacopoeia published the final version of its informational chapter 1224, which deals with the transfer of analytical procedures mentioned in the document entitled USP 35-NF 30. This became official in May 2012. How is the new document different? The US Pharmacopoeia had earlier issued the 1224 stimuli document in response […]

USP 1058 analytical instrument qualification

USP 1058 analytical instrument qualification is about ensuring that an instrument is suitable for its intended use and application. While system suitability and method validation activities have specific guidelines and procedures; analytical instrument qualification is not so specific. There are conflicting opinions and viewpoints regarding USP 1058 analytical instrument qualification. Though subjective, analytical instrument qualification […]

Sterilization

In lay terms, sterilization is understood in a number of ways. We have sterilization in economics, in family planning and in many other fields. When it comes to this term as used by the FDA; there is a specific purpose and definition. For the FDA, sterilization process controls are indispensable for validation. Sterilization is part […]

Q7 guidelines

Q7 guidelines are those guidelines issued by the ICH (International Conference on Harmonization) in relation to Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredient (API). Q7 guidelines are very comprehensive More than 12 years after they were mooted in November 2000; Q7 guidelines continue to be the driving force for API GMP regulations around the […]

Method transfer FDA

A method transfer is the process of qualifying a laboratory regarding its ability to carry out an analytical test procedure. For method transfer, FDA has some regulations that are simple on the face of it, but require many steps and precautions. Not being in compliance with these steps could invite investigation and corrective measures to […]

Master Production Record (MPR)

A Master Production Record (MPR)is one of the several important documents that a manufacturer of finished pharmaceuticals has to maintain and furnish. It is one of the indispensable parts of pharmaceutical good manufacturing practices (GMP’s). FDA’s regulations on Master Production Record (MPR) are found in Code of Federal Regulations (CFR)’s Title 21, Volume 4. The […]

ISO 13485 statistical techniques procedure

Being the global standard for quality management systems in medical devices; ISO 13485 has many controls and checks built in at various stages of the product design and development. One of these is the ISO 13485 statistical techniques procedure. This is a means to ensuring that product characteristics and process capability are measured and checked […]

ISO 13485 purchasing procedure

ISO 13485 has purchasing procedures for suppliers. ISO 13485 purchasing procedure is listed in Section 7.4 and its sub sections. The outstanding feature of this section is that the ISO is not clear about the expected levels of control a supplier has to have in place. It simply states that a documented procedure is required […]