FDA Regulatory Compliance

FDA regulations are meant to protect and promote public health, as well as to ensure food safety and quality. Core areas of FDA regulation include Good Documentation Practices Guidelines, Good Manufacturing Practices, Process Validation, FDA Medical Device GMP Guidelines, FDA Warning Letters, FDA 483, etc.

Good Documentation Practice Guideline is simple: just write

In the FDA's line of thinking, anything that is not written has never happened. So, knowing how to write what has to be written is at the center of FDA Good Documentation Practices. more...


Good Manufacturing Practices are essential for ensuring quality

GMPs are critical for the manufacture and distribution of foods, drugs and other pharmaceutical products. These need to be implemented diligently by organizations that are involved in these products. more...


A Tour of FDA

A tour of the FDA is something like a snapshot of what the FDA does. The importance of the FDA can never be understated: It regulates products from the proverbial pin to airplane in the food, medical devices, pharma and healthcare industries, which touch almost every aspect of American lives. The products that the FDA regulates account for about a trillion dollars, which make up about a quarter of all goods traded in the US. more...


Aspects of Regulatory History in the US

A look at the aspects of regulatory history captures the milestones of all that has happened to the USFDA since its inception. This certainly is no small topic! From the time of its founding in whatever form, till now, there has been a very short gap between the history of the FDA and American history itself. Less than a century since the War of Independence, the new nation was on the road to writing the first chapters of the aspects of its regulatory history. more...


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

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. more...


FDA 21 CFR Part 11 Compliance

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. more...


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

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 more...


A brief understanding of the FDA General Principles on Process Validation

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. more...


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

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. more...


Analytical Instrument Qualification and System Validation

Analytical instruments used within a GMP environment need to be both qualified and validated. This is done because both the firmware that is used within the analytical instruments, as well as their software that comes into interaction with a play station that is situated adjacent to it, are computerized. more...


The FDA's requirements for Drug Applications and Submissions

The FDA has set out requirements by which it accepts drug applications and submissions. It accepts drug applications and submissions through two formats, the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). The NDA and the ANDA are the mediums through which the FDA eventually approves drug applications and submissions. more...


A word about the Drug Development Process

The heart of all the stages a drug undergoes is the development process. Within the drug development process lies a description of each and every step that goes into the development of the drug. more...


Understanding HVAC in a Regulated Environment

Heating, ventilation and air-conditioning (HVAC) is a highly regulated area. HVAC works in a regulated environment primarily because it concerns the environment. There are millions of users of products in this category, and these products are known to be high emitters of pollutants into the environment. more...


Having an Integrated GRC calls for thoughtfulness

Governance, Risk and Compliance (GRC) is a core area of businesses. A GRC system is the key to ensuring that processes are in place and that they are carried out in an automated fashion rather than being done manually. Automation is the operative part of the GRC process, because it makes a lot of sense to automate these processes. more...


Investigational New Drug Applications in the USA

Under current Federal law any manufacturer wanting to market a drug in the US has to subject the drug to an approved marketing application before its transportation and/or distribution in the different States in the US. Since there is a strong possibility that the sponsor of a clinical trial may want to ship the investigational drug to clinical investigators across several states, the sponsor would ideally look to get exempted from this legal requirement. The mechanism through which this exemption issues to the sponsor from the FDA is the Investigational New Drug Applications in the USA. more...


FDA's Foreign Inspections are led by comprehensive regulations

Right from 1955, the FDA has been performing international inspections. This particular activity of the FDA has been codified under The Guide to International Inspections and Travel. more...


What are FDA Recalls?

A recall is an FDA-initiated or voluntarily made removal of a product from the market. While on most occasions it is the FDA that carries out the recall, i.e., asking the company to remove a suspect product based on its observations; on many others, an FDA recall can also be initiated by the company. This is when the company discovers an issue and reports it to the FDA and orders its recall from the market on its own volition. On yet other occasions, a company recalls a product after the FDA raises concerns. more...


FDA Warning Letters -an understanding

In the course of its primary work of being the regulator of the biological, healthcare, life sciences and other related industry; the FDA has overarching authority over how it ensures that its work is carried out. One of the primary instruments through which it enforces its authority is FDA Warning Letters. more...


The FDA Form 483 - what is it?

The FDA carries out inspections on clinical trial sponsors, clinical trial investigators, Institutional Review Boards (IRB) and facilities that manufacture, process or pack FDA-regulated products from time to time to ensure compliance with its regulatory requirements. The main objective of these inspections is to ensure that companies in these industries meet the required standards. This is in tune with the FDA's stated purpose of ensuring public health. more...


Tougher FDA import rules are aimed at putting strict controls on imports

As a result of the tougher FDA import rules one of the toughest challenges importers of drugs and medical devices in the US face is getting past the FDA. With the FDA collaborating with the Customs and Border Patrol Service (CBP); this regulatory agency has become armed with even more teeth, putting tougher import rules in place. In partnership with the CBP; the FDA has increased its sophistication in relation to the requirements that importers have to adhere to for submitting information and adhering to set procedures laid out by the government in this regard. more...

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