Q7 Q&As - Quality Guidelines : ICH

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Q7 Q&As - Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Follow this link to the Q7 section: Q7 Q&As - Quality Guidelines : ICH:

"Experience gained with the implementation of the ICH Q7 Guideline since its finalisation in 2000 shows that uncertainties related to the interpretation of some sections exist. Technical issues with regard to GMP of APIs – also in context with new ICH Guidelines - are addressed in this Question and Answer document in order to harmonise expectations during inspections, to remove ambiguities and uncertainties and also to harmonise the inspections of both small molecules and biotech APIs."

'via Blog this'

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FDA 101 Digital Health Guide - Free Rock Health Report

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Does your mobile health app need FDA clearance? Checklist gives guidance for digital health entrepreneurs | MedCity News:

In a report dubbed “FDA 101,” health startup accelerator Rock Health has compiled a handy report to help digital health entrepreneurs assess whether their mobile health apps would be classified as medical devices by the FDA and require 510(k) clearance. Rock Reports - FDA 101 - A guide for digital health entrepreneurs

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The Designated Representative Institute

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FDA Dietary Supplement Guidance for Small Businesses

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The FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance document restates in plain language the legal requirements set forth in the DS CGMP rule (21 CFR part 111). The DS CGMP rule is binding and has the full force and effect of law:

FDA: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide

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Flu.gov Updated by HHS - New Resources Added

The government's Department of Health and Human Services (HHS) unveiled several new resources on the federal government's one-stop resource for flu information -- https://www.cdc.gov/flu/. Some of the new items include:

• A self-evaluation guide
• A myth and facts section

Stay well!

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FDA Quality by Design - QbD - Executive Guide (pdf)

According to Cerulean Associates' Why Quality by Design? - An Executive's Guide to the FDA's Quality by Design (pdf), "Quality by Design is one of the most misunderstood and misused tools available to biopharmaceutical and medical device executives." The guide is easily understood and closes by driving to a 7-step QbD start-up plan. According to the guide, "the best way to assess how to implement QbD in your organization without making the same mistakes that other companies have made is to utilize a simple 7 step process."

Here's to hoping you enjoy and find this guide a good read, as I found it.

Related Posts:
Quality by Design (QbD) For Analytical Methods (video)

#FDA #GMP #training #cGMP

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Think Like An FDA Inspector - Be Prepared

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Revised December 16, 2020

Yep, it's important to follow all the regulations. AND, it helps to understand how the FDA inspector will approach your company during an inspection. On the FDA website, several free documents are published as reference material for investigators and other FDA personnel. The documents don't bind the FDA and don't confer any rights, privileges, benefits or immunities for or on any person(s). Basically, they'll help you prepare and anticipate what to expect from an FDA inspector and inspection team. Just be forewarned, it also means that they don't have to follow the suggestions or recommendations mentioned in the inspection guides. Here's a listing of the major categories of inspection guides that are available . . .

"Guide to Inspections of:

• Biotechnology
• Computer Issues
• Devices
• Drugs
• Foods & Cosmetics
• Miscellaneous

Note: These documents are reference material for investigators and other FDA personnel. The documents do not bind FDA and do not confer any rights, privileges, benefits or immunities for or on any person(s). An alternative approach may be used if such an approach satisfies the applicable statutes, regulations or both."

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Time To Talk About Turkey Cooking and Food Safety

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Thanksgiving is here, and it's time to cook the turkey. Just be sure to follow some basic turkey cooking tips for a delicious turkey without making your family, friends, and guests sick. Here's an excellent tip sheet from the USDA, "Let's Talk Turkey—A Consumer Guide to Safely Roasting a Turkey." A sampling of the tips include, fresh or frozen, stuffing, thawing, microwave, roasting, timetables, and much more . . .

Previous or related posts: 

Thanksgiving Alert - Cooked Turkey Can Still Cause Food Poisoning!
FDA CFSAN - Food Safety and Nutrition Video Library (free)
FDA Launches Food Defense Awareness Training Kit For Employees In The Food Industry
21 CFR Part 110 - cGMPs for Food - free online 

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Designated Rep Certification Class
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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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