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Adam Fleming's Blog – September 2017 Archive (14)

Who are involved in filing investigational new drug applications

Lack of data integrity or the presence of anomalies in data is one of the primary reasons for which the FDA hauls up and penalizes an organization engaged in pharmaceutical manufacturing. As the use of analytical methods for drug quantification at many stages of drug development process grows in prevalence; the need for scientists, technicians, and quality assurance personnel, etc. to understand the complete validation process of the analytical method has…

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Added by Adam Fleming on September 28, 2017 at 6:19am — No Comments

U.S. asks China not to enforce cyber security law

GENEVA (Reuters) – The United States has asked China not to implement its new cyber security law over concerns it could damage global trade in services, a U.S. document published by the World Trade Organization showed on Tuesday.

China ushered in a tough new cyber security law in June, following years of fierce debate around the move that many foreign business groups fear will hit their ability to operate in the country.

The law requires local and overseas firms to submit to…

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Added by Adam Fleming on September 27, 2017 at 5:56am — No Comments

How to uncover fraud, and put a plan in place to prevent it going forward

Internal fraud, by which people who work for an organization are themselves involved in fraud, is a serious issue for businesses. This kind of fraud is very insidious, as it is stealthy and is almost impossible to detect. Accounts Payable, a core component of most organizations, is one of the primary areas of fraud. This AP fraud is something organizations don’t seem to be precluded from, no matter what the nature of their business or its size.

Yet, learning to…

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Added by Adam Fleming on September 26, 2017 at 6:23am — No Comments

Crypto-Mania Grips Hong Kong as City Looks for Life Beyond Banks

In the mid-1990s, Johnson Leung embarked on a career in shipping. In the early 2000s, he moved to finance. And now, he runs a Hong Kong startup that aims to improve how container ships are booked using blockchain technology.

Many in Hong Kong hope the city can make a similar leap. The shipping and banking hub, which has struggled for years to nurture a domestic technology industry, is embracing the blockchain revolution as it looks for new sources of…

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Added by Adam Fleming on September 25, 2017 at 5:45am — No Comments

The fourth season of Gurgaon's biggest & most popular food awards concludes with fervour

Some of the biggest names of India’s hospitality industry descended at the Hyatt Regency Hotel Gurgaon on Wednesday evening to celebrate the fourth season of ‘The Big F Awards’ – undoubtedly, Gurgaon’s biggest & most popular food awards.

The gala event was marked with the presence of bigwigs from the food & beverage…

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Added by Adam Fleming on September 22, 2017 at 5:55am — No Comments

FDA Warns on Mixing Opioid Addiction Treatments, Other Meds

TRENTON, N.J. (AP) — The Food and Drug Administration issued new warnings Wednesday about the dangers of combining medication for opioid addiction with anti-anxiety medicines and other drugs that also slow breathing and brain activity.

The FDA warned that mixing such drugs can cause difficulty breathing, coma or death, so it should be done with caution.

The agency said…

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Added by Adam Fleming on September 21, 2017 at 6:04am — No Comments

Q7 and Other Requirements for Active Pharmaceutical Ingredient (ASM) GMP

In late 2016, the FDA published the revised the Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry. The aim of this revision is to address Good Manufacturing Practices (GMPs) for a Quality Management System for Active Pharmaceutical Ingredients (API’s). Another of its aims is to help companies ensure that they meet the requirements of API quality and purity characteristics. While replacing Q7A Good Manufacturing Practice…

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Added by Adam Fleming on September 20, 2017 at 6:27am — No Comments

Nitinol-based Medical Devices 2017 Global Market Expected to Grow at CAGR 10.50 % and Forecast to 2021

About Nitinol-based Medical Devices

Nitinol-based medical devices are made of nitinol, an alloy of nickel and titanium. The use of nitinol-based stents and guidewires has improved procedural outcome. The nitinol alloys are corrosion resistant and are highly accepted in the medical device industry. The global medical devices market has been growing extensively over the years. With increasing investment in research and development (R&D) for manufacturing…

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Added by Adam Fleming on September 19, 2017 at 6:05am — No Comments

A common technique plots the data to help detect trends, cycles, and shifts

Some of the functions of medical device manufacturers include:

o  Analyzing complaints

o  Processing data

o  Evaluating nonconformances

o  Utilizing other quality data sources.

The main purpose of this analysis, done using appropriate statistical methodology, under §820.100, is to identify the cause of nonconforming products and other quality problems. Time series analysis is one such family of these tools. Also called trending analysis,…

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Added by Adam Fleming on September 18, 2017 at 6:49am — No Comments

A clear process for compliant laboratory OOS investigations

The core of successful operation by a drug maker is laboratory testing. current Good Manufacturing Practices (cGMP) regulations require a drug manufacturer to use laboratory testing as a tool to validate that everything that goes into a laboratory product, such as in-process materials, finished materials, and containers adhere to set specifications. When all these are done, a major challenge for laboratories is in how to deal with a test that shows an…

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Added by Adam Fleming on September 12, 2017 at 5:59am — No Comments

How to Recognize the Hazards of Blood Borne Pathogens

Bloodborne pathogens are those microorganisms present in the human blood that carry infection. These infections can cause disease in humans. The major bloodborne pathogens that cause infections in humans are:

o  Hepatitis B (HBV)

o  Hepatitis C (HCV)

o  Human immunodeficiency virus (HIV)

Although these are the main disease causing pathogens; there are many more. So, hospital staffs who deal with patients who are infected by…

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Added by Adam Fleming on September 8, 2017 at 5:46am — No Comments

What is the legal language of the FDA form 1572 or Device equivalent?

Form FDA 1572 is one of the primary documents needed when carrying out a clinical trial. Also called the Statement of Investigator; Form FDA 1572, called just 1572 informally, is a contract between the Principal Investigator (PI) and the FDA. This form contains all details of the subjects, as well as commitments from the PI.

It is a contract in which the Principal Investigator, the person who is…

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Added by Adam Fleming on September 6, 2017 at 6:11am — No Comments

How to Achieve the best Outcome in an Audit

An internal audit, as we all know, is carried out for a number of specific purposes, the main one among which is to assess the adherence to the industry guidelines for quality and processes. Helping the organization meet the requirements of processes and standards, which are usually issued by regulatory agencies and other relevant bodies and boards, is the main aim…

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Added by Adam Fleming on September 4, 2017 at 5:36am — No Comments

cGMP Data Integrity is of Critical Importance

Of late, the FDA has been turning on the heat on manufacturers in the FDA-regulated industries that violate its regulations. It has a penchant for going after manufacturing facilities that show laxity in implementing current Good Manufacturing Practices (cGMP). This ardor is understandable. cGMP violations affect the quality of the product; hence the strictness, considering that it is patients who consume these products.

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There are ways of ensuring that the product…

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Added by Adam Fleming on September 1, 2017 at 6:05am — No Comments

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