FDA - 8 Free Tips For Effective 483 Responses

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Updated February 2, 2021

The original link broke.

People also ask about:

FDA Form 483 Frequently Asked Questions - FDA.gov

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OK, now that you've gotten that darn 483, now what?!

Here are 8 free tips on how to effectively respond to a 483 (pdf), and these tips come from the FDA.

Intro To The FDA GMPs - free 3 minute video

This free, short, video clip on YouTube, makes an excellent, "Introduction to Good Manufacturing Practices (GMPs)." This is a nice and easy way to expose new employees to the whole concept of the regulated pharma industry and the FDA regulations. Naturally, this clip is a trailer promotion of a training video sold by the producer. In any event, make use of this very useful, and free video clip.

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The FDA Drug Approval Process

Updated July 15, 2020

The link in the original post broke.

You might also be interested in this:
Development & Approval Process | Drugs (on the FDA.gov website)

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I always have to remind myself what's involved in getting a drug to market. This eSSORTMENT article is short, sweet, and a great overview of the process, "The FDA drug approval process - The FDA has an elaborate clinical process that examines new drugs for distribution to the public with its seal of approval." I've seen it stated in some other places I've read, that it can take about 15 years to 'birth' a new drug.

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Free WHO Training Guide To GMP Requirements

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Updated 9/24/2015:  

The original link below is broken. Try this new link:
A WHO guide to good manufacturing practice (GMP) requirements Part 3: Training

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This is a wonderful free resource for those involved in or responsible for delivering GMP training or classroom sessions. The World Health Organization (WHO) published this guide, so that it could "help both trainers and supervisors solve some of the problems they face involving training, such as how to make the training interesting to adult learners or how to effectively use a variety of instructional methods."

A WHO Guide To Good Manufacturing Practice (GMP) Requirements, Part 3: Training, is organized by the following major chapters:

1. Introduction and purpose of this guide
2. The importance of training
3. Types of training and content areas
4. Developing and implementing training
5. Assessment and evaluation
6. Administrating a training programme
7. Questionnaire

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Free 21 CFR Part 820 QSR Audit Checklist

• FDA GMP Online Training - popular CGMP online training courses offered by SkillsPlus International Inc.

FDA Guide to Inspections of Quality Systems

Updated February 13, 2021

Some posts just don't age well (i.e., broken links below). 

You might also be interested in:
FDA - Guide to Inspections of Quality Systems

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Don't be caught flat-footed, be ready for the FDA. "Highlight any compliance gaps in your quality management system with a comprehensive FDA GMP Checklist...," says Chris Scholl Consulting Associates. On their site, they offer a free checklist, "21 CFR 820 Audit Checklist." If you don't know where or how to start, they suggest a couple of things to think about, "Are You Ready for the FDA?"

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.

• This class prepares plant personnel to participate in an FDA Inspection.

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Free GMP Training Tips - Follow adult learning principles

• FDA cGMP QSR GMP Online Training - by SkillsPlus International Inc, a provider of cGMP online training classes

Updated January 10, 2021

The links in the original post broke.

You might also be interested in:
Mining Publication: Principles of Adult Learning

Strategies For Improving Miners’ Training (PDF)

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Are you planning an upcoming GMP training session? If you are, every now and then, it's always a good idea to review the principles of adult learning. Then as you're working out the class curriculum and agenda, you can be sure to pay attention to the major adult learning principles and adjust your plan for training. Training grown-ups is challenging. Having an awareness of the challenges is half the battle.

Free resources about adult learning:

1. Adult Learning Tip 1: Developing a Curriculum
2. Adult learning Tip 2: Understanding Principles - using training of miners as an example
3. Adult learning Tip 3: Applying Principles - using training of miners as an example

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FDA 101: Dietary Supplements - Things you should know

Updated May 2, 2024

Read this to learn more about dietary supplements. This is another perfect example of how drugs, prescriptions, and dietary supplements intersect the FDA GMPs (good manufacturing practices). According to the FDA, in "FDA 101: Dietary Supplements," ... "The law defines dietary supplements in part as products taken by mouth that contain a "dietary ingredient." Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet." You might want to be concerned if you have certain health conditions, because in some instances, if you take these products, you may be putting yourself at risk. The article recommends consulting a health professional if this is your situation. The major topics covered are: talk with a healthcare professional; how are supplements regulated; are supplements safe; be a safe and informed consumer.

The FDA is involved because it stipulates some regulations. For example, "in general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded."

Additional resources on dietary supplements:

1. Final Rule Promotes Safe Use of Dietary Supplements - another free consumer-oriented FDA article
2. The final rule on CGMPs for dietary supplements - available free on the FDA website, these regulations will interest manufacturers
   

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New FDA Guidance - cGMP Practice for Phase 1 Investigational Drugs

There was lots of coverage on this recently released FDA guidance, "Guidance for Industry - CGMP for Phase 1 Investigational Drugs. " (PDF) I'm posting the link to this guidance so that it can be easily found and downloaded. Here's what the introduction in the guidance says . . .

• This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials.2 These drugs, which include biological drugs, are exempt from complying with 21 CFR part 211 under 21 CFR 210.2(c) (referred to as phase 1 investigational drugs).


• Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. This guidance applies, as part of CGMP, quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects.


• This guidance replaces the guidance issued in 1991 titled Preparation of Investigational New Drug Products (Human and Animal) (referred to as the 1991 guidance) (Ref. 1) for the manufacture of phase 1 investigational drugs described in this guidance (see section III). However, the 1991 guidance still applies to the manufacture of investigational new products (human and animal) used in phase 2 and phase 3 clinical trials.


• The guidance finalizes the draft guidance entitled "INDs—Approaches to Complying with CGMP During Phase 1" dated January 2006; and is being issued concurrently with a final rule that specifies that 21 CFR part 211 no longer applies for most investigational products (see section III), including certain exploratory products (Ref. 2) that are manufactured for use in phase 1 clinical trials. The agency recommends using the approaches outlined in this guidance for complying with § 501(a)(2)(B) of the FD&C Act.


• FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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21 CFR Part 110 - cGMPs for Food - free online

Get your money's worth for your tax dollars. The FDA publishes these food regulations online on their FDA website, and they're available for free! I'm posting these because of the recent tomato and pepper Salmonella scare, and my recent post on the 'fruitcake of the Shuttle astronauts' FDA warning letter. Here's what you get from the FDA . . .

NOTE:
When you open any of the links below, be sure to look at the upper left portion of the page to see the revision date.

Title 21 -- Food and Drugs
Chapter 1 -- Food and Drug Adminstration
Department of Health and Human Services

SubChapter B -- Food for Human Consumption
Part 110
CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

Subpart A--General Provisions
§ 110.3 - Definitions.
§ 110.5 - Current good manufacturing practice.
§ 110.10 - Personnel.
§ 110.19 - Exclusions.

Subpart B--Buildings and Facilities
§ 110.20 - Plant and grounds.
§ 110.35 - Sanitary operations.
§ 110.37 - Sanitary facilities and controls.

Subpart C--Equipment
§ 110.40 - Equipment and utensils.

Subpart D [Reserved]

Subpart E--Production and Process Controls
§ 110.80 - Processes and controls.
§ 110.93 - Warehousing and distribution.

Subpart F [Reserved]

Subpart G--Defect Action Levels
§ 110.110 - Natural or unavoidable defects in food for human use that present no health hazard.

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Internet Ayurvedic Medicines Contain Toxic Metals

It turns out that toxic metals can be found in Ayurvedic medicines sold online, according to a JAMA article, "Lead, Mercury, and Arsenic in US- and Indian-Manufactured Ayurvedic Medicines Sold via the Internet. (abstract)" Here's what I've learned in doing some reading . . .

1. There are two major types of Ayurvedic medicines: herbal-only and rasa shastra, which is an ancient practice of deliberately combining herbs with metals (e.g., mercury, lead, iron, zinc), minerals (e.g., mica) and gems (e.g., pearl). Rasa shastra experts claim that these medicines are safe and therapeutic when properly prepared and administered.
2. One-fifth of both US-manufactured and Indian-manufactured Ayurvedic medicines purchased via the Internet contain detectable lead, mercury, or arsenic. All metal-containing products exceeded 1 or more standards for acceptable daily intake of toxic metals.
3. The research also collected information about claims of Good Manufacturing Practices (GMPs). Among the metal-containing products, 95% were sold by US Web sites and 75% claimed Good Manufacturing Practices.

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FDA Warning Letter - Space Shuttle Fruitcake

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Updated March 6, 2019

WSJ put the article behind their subscription wall, and the link to the warning letter has broken.

You might also be interested in:

FDA: Pardon Me, But Your Bakery Warehouse Is Full Of "Rodent Excreta Pellets" - Consumerist

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This would be amusing if it wasn't so serious. I recommend you read this, and share it during an upcoming GMP training or classroom session. At first, I was slightly amused and drawn to this WSJ article by its headline, "Pay No Attention to the Mice Behind the Pallets." Then I read, and was appalled. Read on and take a gander at the FDA warning letter to Capitol Cake Co. BTW, they've proudly supplied fruitcake for the space shuttle program.

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FDA 483 Inspectional Observations - learn from these examples

• FDA cGMP QSR GMP Online Training - respected cGMP online training classes offered by SkillsPlus International Inc.

Here's a small collection of 483s (FDA Form 483 Inspectional Observations). If you've never seen one before, here's your chance. Take advantage of these to learn and share, so that you can avoid getting your own 483s. You can view these on the FDA's website, in the FDA Office of Regulatory Affairs (ORA) Electronic Reading Room. They display copies of ORA records. ORA makes these records publicly available either (1) proactively at their discretion or (2) because they are "frequently requested" per the Electronic Freedom of Information Act Amendments of 1996. Some records may be redacted to remove non-public information.

According to GMP Trends Inc., "an FDA 483 is a form used by an FDA investigator following an inspection of your plant. It lists deficiencies in your quality system and potential non-compliance issues with GMP's. These observations are based on the investigators interpretation of the GMP regulations as they apply to your specific situation. During the investigator's closing meeting with management, you may be given a Form 483." You can learn more about the FDA's thinking on 483s by reading this section from one of their manuals, FDA Investigations Manual - Reports of Observations.

These 483s can do several things for you. They'll:

1. Get you more familiar with what a 483 is all about
2. Give you the willies so you'll never want to earn your own 483s
3. Provide examples that you can incorporate into your GMP training efforts

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Hi-Tech Pharmaceuticals - Purported assassination, blackmail plots

• FDA GMP QSR cGMP Online Training - GMP online training offered by SkillsPlus International Inc.

This reads like a TV show. Sadly, it's all too real. You'll want to share this story during your GMP training and classroom teaching. The courtroom charges were conspiring to import and distribute adulterated, mislabeled and unapproved new drugs and to commit mail and wire fraud. Even more outrageous is a mention that the defendants allegedly conspired to murder a U.S. Food and Drug Administration agent and blackmail a former assistant U.S. attorney general.

For the full story, read this MSNBC article, "From diet supplements to illegal Net pharmacy - Ga. firm, 3 execs plead guilty to selling generic prescription drugs online."

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It Is August 2008 - Upcoming GMP Public Seminars

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2008 is starting to come to an end. Be sure to send your key personnel to training this year. Here's what I came up with while searching for some GMP-related public seminars during the remainder of the year . . .

1. SkillsPlus International Inc. - Public Seminars

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Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
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GMP Olympics - an onsite training experience

I couldn't resist. The 2008 Olympics are with us. Well, you don't have to be an athlete to go to the Olympics. I discovered this playful title of a GMP training offering, "GMP Olympics." It sounds like fun, involving forming teams and having some friendly competition around the FDA's good manufacturing practices.

Previous posts about GMP training or games:
The Health, Drug, Prescription, and GMP Supersite: C2EO - A fun GMP training game

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C2EO - A fun GMP training game

• Recommended FDA cGMP online training programs and courses taught by SkillsPlus International Inc.

Updated August 26, 2024:

I believe the FDA cGMP training industry continues to evolve.  It's my sense that there are fewer, and fewer companies offering hardcopy board games for cGMP training.

BTW, the C2EO game is no longer available.

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Here's a fun game to use, to make your GMP training fun, C2EO. Watch this video teaser for a flavor of the game, "C2EO - a cGMPs training game." The mantra of the game is, "compliance is the rule, knowledge is profit."

Other resources to make GMP training fun:

1. The Health, Drug, Prescription, and GMP Supersite: 2 Free GMP Training Tips - Make It Fun!

#FDA #GMP #training #cGMP

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