GMP Compliance for Pharmaceutical Laboratories

GMP Compliance for Pharmaceutical Laboratories Key Takeaway: In order to ensure GMP compliance, pharmaceutical laboratories have to devise a holistic and long term plan that covers all aspects of the laboratory’s activities. Good Manufacturing Practices (GMP) requirements for laboratories have been set out by various regulatory bodies. The aim of GMP compliance for a pharmaceutical […]

A sound Food Safety Management System is an imperative in today’s globalized food supply chain

A sound Food Safety Management System is an imperative in today’s globalized food supply chain Key Takeaway: A food safety management system is absolutely necessary for ensuring public health. This is all the more important in today’s globalized world, in which food knows no national borders or boundaries. First, let us get an understanding of […]

A brief look into the nature of FDA medical device GMP guidelines

Key Takeaway: The FDA’s guidelines on medical devices GMP regulations are broad and flexible. The onus of proving compliance with the guidelines in accordance with appropriate sections of part 820 lies with the manufacturer. The FDA has issued Good Manufacturing Guidelines for medical devices. This is necessary since medical devices constitute one of the major […]

A brief understanding of the FDA General Principles on Process Validation

A brief understanding of the FDA General Principles on Process Validation Key Takeaway: The FDA has issued vastly improved and expanded general principles on process validation in January 2011. These build substantially on the previous issue of 1987. The FDA describes Process Validation as “the collection and evaluation of data, from the process design stage […]

Implementation of FDA 21 CFR Part 11 Regulations optimizes an organization’s capabilities

Implementation of FDA 21 CFR Part 11 Regulations optimizes an organization’s capabilities Key Takeaway: On the surface, FDA 21 CFR Part 11 regulations appear confusing, but following a risk based approach to computer systems validation sorts these out, increases the organization’s computer systems efficiency and reduces costs FDA 21 CFR Part 11 regulations have been […]

FDA 21 CFR Part 11 Compliance

FDA 21 CFR Part 11 Compliance Key Takeaway: FDA 21 CFR Part 11 Compliance sets out benchmarks by which FDA-regulated industries’ electronic signatures and other records are considered authentic. From 2007, a strong body of opinion has emerged challenging the stringency of these requirements, but nothing major has been diluted from these. The regulations under […]

Going by the FDA 21 CFR Part 11 Checklist is a good way to stay on track

Going by the FDA 21 CFR Part 11 Checklist is a good way to stay on track Key Takeaway: It makes sense for organizations that are part of 21 CFR Part 11 to have a checklist of requirements, as this helps eliminate thorny issues. There is considerable confusion about the requirements of electronic signatures set […]

Electronic Health Records -an understanding

Electronic Health Records -an understanding Key Takeaway: EHRs are a shining example of the advancements being made in the technology the American healthcare system uses. They need to be comprehended properly to facilitate their adaption. The terms Electronic Health Record (EHR) is self-explanatory: it signifies an electronic version of paper medical records of a patient. […]

The EHR Incentive Program is what it is -an incentive for healthcare providers to digitize

The EHR Incentive Program is what it is -an incentive for healthcare providers to digitize Key Takeaway: The Centers for Medicare & Medicaid Services (CMS) are involved in a mammoth task of digitizing patient health records. They use the bait of incentives to accelerate the process while maintaining quality. Digitizing health records is a mammoth […]

Effective Complaint Handling Guidelines serve as a basis for improvements in medical devices

Effective Complaint Handling Guidelines serve as a basis for improvements in medical devices Key Takeaway: Far from being frowned upon, complaints should serve as an opportunity for medical device manufacturers to understand the customer’s expectations better and lead to improvements in the product quality. The FDA describes a complaint as “any written, electronic, or oral […]