Monday, July 13, 2009

Compliance with the New Draft Guidance on Process Validation

FDA have released a draft Guidance document titled "Guidance for Industry - Process Validation: General Principles and Practices .The following categories of drugs are within the scope of this guidance: Human drugs Veterinary drugs Biological and biotechnology products Finished products and active pharmaceutical ingredients (API or drug substance)The drug constituent of a combination (drug and medical device) product The following categories of products are not covered by this guidance: Type A medicated articles and medicated feed Medical devices Dietary supplements Human tissues intended for transplantation regulated under section 361 of the Public Health

The draft guidance can be found at

Article - FDA's New Process Validation Guidance Recommends Team Approach

Webinar on this topic -

Manage a Medical Device Recall Efficiently and Effectively

Medical device recalls are very common now days. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. It might be worrisome for people who are using a medical device and suddenly the recall is announced, here it might be logical to remove the device but it is not always need to be done. But it is essential for doctors to inform their patients what are the risks of removing it VS using a faulty device.

Attend a webinar on How to Manage a Medical Device Recall Efficiently and Effectively hosted by Complianceonline and available at price $199

Webinar Implementing GLP in Contracting Laboratories

It must be understood that in contract laboratories the GMP or GLP compliance lies with the study sponser, and hence it becomes necessary to know what are the roles and responsibilities of key Management, Supervisors, Scientists, Principal Investigators, Regulatory, QAU and other personnel in GLP facilities, contract laboratories.

Here are some webinars to refer.

webinar Related to Electronic Health Records (EHRs)

Using Electronic Health Records and Claims Databases for Rapid-Response Pharmacovigilance Studies

Leveraging EHR Stimulus Funding During Contract Negotiation

Complaint Handling - How FDA and ISO Regulations effect

Compliant handling is one of the most important customer feedbacks which can never be missed. Many warning letters cite wrong way handling of compliant as one of the main reasons of receiving warning. But it is confused by most of the manufacturers do not know how to document customer feedback, what constitutes a complaint and non-compliant feedback, and what do with "non-complaint" feedback. Some companies merey just implement the compliant management software with out knowing the rules and processes and end of hurting more to them selves. It is imperative to know what ISO and FDA regulations effect the compliant handling process.
Here is a webinar by ComplianceOnline on Complaint Handling in Compliance with FDA and ISO Regulations which gives and over view of solutions to the above problems mentioned.

Customer compliant software -

Risk Based CAPA system - closed loop

Expectations for meaningful, results driven CAPA activities are increasing among regulatory agencies world wide. Almost 60-70 % of warning letters are related to CAPA. EU’s ISO 14971 and the FDA’s QSIT and Q9, underscore this increased emphasis. Growing high-profile field problems indicate that QA / CAPA activities are not yet fully utilizing the power of current risk management tools. The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop CAPA as an integral part of Quality Management Systems planning, implementation and execution.
The essential component of a closed loop CAPA system is how you re organize and distribute the scare resource for those activities which has higher opportunity cost and high value.
You can attend a webinar hosted by ComplianceOnline and available at discounted rate

Federal preemption case for medical device

In the United States, Federal preemption refers to the displacement of state law by Federal law

Federal pre-emption is the notion that, if the U.S. Food and Drug Administration (FDA) approves a medical device, injured patients should not be able to sue product manufacturers by alleging defective warnings.

There is a classic case of Riegel v. Medtronic in regards to the federal preemption

Read More click here

Friday, July 10, 2009

Reportable Food Registry Draft Guidance

The RFR is scheduled for implementation on September 8, 2009, and applies to all FDA-regulated categories of foods, including dietary supplements. Only infant formula is exempt from the RFR requirements.

The RFR requires a responsible party to file a report through an FDA internet portal when there is reason to believe that an adulterated food (other than infant formula) will cause serious adverse health consequences or death to humans or animals. "Responsible party" is defined as the person who submits the registration information to FDA for a food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States. Federal, state, and local government officials may also use the portal to report information that may come to them about such foods.

Submit electronic comments on the draft guidance to

Find out what are its implecations and loopholes click the link below

Drug establishment registration and drug listing Regulation

From June 1, 2009 FDA is no longer accepting paper submissions for drug establishment registration and listing unless a waiver is granted.

Both information were been submitted using a paper-based format, i.e., Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments' Report of Private Label Distributors). But now FDA will not accept anything on paper and would rather accept fully compliant electronic submission.

Also by Jan 1, 2010 starting 1 January 2010. Some regulatory authorities in Europe have implemented all electronic review environments ahead of this deadline and are refusing to accept paper submissions for review. Many authorities are receiving the eCTD files with full of error and non compliant submissions and finding difficulty in navigating through it.

Section 510 of the Act and 21 CFR part 207, subject to certain limited exceptions, require establishment owners and operators (registrants) upon first engaging in the manufacture, preparation, propagation, compounding, or processing of drugs, (including human drugs, veterinary drugs, and biological drug products 4 ) to register their establishments and submit listing information for all drugs in commercial distribution. Registrants are also required to submit registration information for their establishments on or before December 31 of each year.

At the time of registration, registrants must also submit required listing information. Additionally, registrants are required to update listing information in June and December of each year to include information for drugs that have not been previously listed. Certain changes to information for previously listed drugs must also be submitted every June and December.

Purpose of this regulation

FDA intends to update these documents regularly to reflect the evolving technology and user experience.

Receipt of timely and accurate information will enhance FDA’s efforts to help ensure the integrity of the drug supply and protect public health.

The electronic drug establishment registration and drug listing system will permit FDA to electronically populate the Agency’s listing databases and the NDC Directory and will, therefore,improve the inclusiveness and accuracy of these databases.

To read details about this regulation please refer following links


Regulations doc

Thursday, July 9, 2009

Unique Device Identification

UDI stands for a unique serial number given to each medical device. In this scenario, each identical device would be assigned its own serial number which becomes easy to track it through out its life cycle.

On Feb. 12, the U.S. Food and Drug Administration convened a public workshop on development of a unique device identification system for medical devices under the FDA Amendments Act of 2007, which mandates the UDI.

As part of the FDA Amendments Act of 2007 (“FDAAA”), FDAAA does not mandate a specific type of device identifier, but a unique device identifier (“UDI”) must be placed on the device label, unless an alternative location is specified, or unless FDA has exempted the device or group of devices from the UDI system. The UDI must adequately identify the device throughout its distribution and use, and may need to include information such as the lot or serial number, if required by FDA.

It is expected to be coming out in late 2009 and later with a final rule in 2010. There are many discussions going on how to implement it, which devices come under its purview and how it can affect the different sectors.

There are very common concerns are below
1. What all devices or particular type of devices should be subject to the? Which types of devices or particular devices should be excempted?