200+ followers. WOWWWWWW…

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Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

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Breast cancer warning from man stunned by ‘impossible’ diagnosis

Breast cancer warning from man stunned by 'impossible' diagnosis.jpg

When you think of breast cancer, you think of a form of cancer that affects only women. It doesn’t.

While breast cancer in men is rare it’s still an issue for the 10 men on average who are diagnosed with it every year in Northern Ireland.

Ian Cranston, 70, was diagnosed with breast cancer in May. Two weeks later he had a mastectomy.

The Portadown father-of-two was given the all-clear in June and has decided to speak publicly to make men aware that it’s a cancer that doesn’t just affect women.

He said “men also need to check their breasts for changes”.

Inverted nipple

In May, Ian’s wife Elizabeth noticed something wrong when he got out of the shower.

Image copyright SPL
Image caption About 10 men in Northern Ireland are diagnosed with breast cancer each year

She told him he had an inverted nipple and needed to see his GP.

“I didn’t know what that meant,” said Ian.

“Men can’t get breast cancer, I don’t have to go to the doctor.

“I wasn’t aware I had breasts. This is my chest, men don’t have breasts, it’s impossible,” he added.

Eventually his wife persuaded him to go to his GP, who referred him to Craigavon Area Hospital.

Image caption Ian Cranston alongside breast care specialist nurse Annie Treanor

The diagnosis stunned him.

“Men having breast cancer, I couldn’t believe it,” he said.

“I couldn’t do or say anything. My wife Elizabeth cried.”

Four days later Ian said he “just broke”.

He has decided to help try and raise awareness of the disease, saying that if his speaking out helped one man, it would be worth it.

“I can understand where women are coming from because I’ve had breast cancer myself,” he said.

How We Need to Keep Growing Up: http://snip.ly/ljoxy#http://www.bbc.com/news/uk-northern-ireland-41616265

FDA API GMP requirements –current quality guidelines

FDA API GMP requirements –current quality guidelines

The US FDA has set out Good Manufacturing Practices (GMP) requirements for a number of products. The Food, Drug and Cosmetic Act, a US law,empowers the FDA with authority to regulate a number of industries.

Accordingly, the FDA GMP requirements and guidelines exist for a clutch of products and fields. GMP’s for some of these, concerning related areas like drug products, API, excipients, devices and nutritional supplements, may appear to be linked and similar, but they are not. Their definitions, identity, application and requirements may have many common qualities, but each has unique FDA GMP requirements.

Current quality guidelines for API

There are a number of current quality guidelines for FDA GMP requirements. A few of these are:

ICH Q 7

ICH Q 7 was issued as ICH Q 7A in November 2000. It was officially accepted by the FDA as a guideline for API in August 2001.

Q 8 (R2)

Concerning pharmaceutical development, Q 8 (R2) is another of the current FDA GMP requirements. It was issued in November ’09. It has applications to GMP’s.

Q 9

The Q9, concerning Quality Risk Management, was issued in June ’06.

Q 10

The Q 10, specific to the Pharmaceutical Quality System, was issued in April ’09.

Other guidelines concerning PV for APIs

The FDA also has draft guidances for process validation. These are:

  • General Principles and Practices (November 2008)
  • Pharmaceutical Components at Risk for Melamine Contaminations(August 2009)
  • Guidance for Industry –cGMP for Phase I Investigational Drugs (June ’08)
  • CPG Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval
  • 7356.002F –Active Pharmaceutical Ingredients are other important documents.

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The ICH Q 7 A–important sections

The ICH Q 7 A–important sections

The ICH Q 7 A is a globally harmonized GMP guideline for Active Pharmaceutical Ingredients (API). This guideline covers all GMP aspects of manufacturing, quality control and trading of both chemical and biological ingredients of a drug.

The Q 7 was arrived at by the International Conference of Harmonization (ICH), which is why it gets its name. Adapted in November 2000, it came into being after three of the world’s leading medical device markets, namely the EU, Japan and the US agreed to it.

Although a comprehensive guideline that covers almost all aspects of GMP for API in its 19 section; a few sections are more important than the rest. It makes sense to be aware of these sections and implement them for day-to-day use.

  1. Introduction and glossary: Most people only glance at this section and its sub-sections, but it contains very important details. For instance, it contains unique definitions, especially those on API starting materials and manufacturing. Unique definitions by experts are carried here. They help to properly apply the intent of Q 7.
  2. Buildings and facilities: Extremely important because it contains reference to minimum quality of potable water, closed systems and contact utilities.
  3. Process equipment and cleaning:This states that contact surfaces of all materials should not be able to alter the quality of the product or the material beyond stated or established requirements.
  4. Production and inprocess controls: This section is vital because it states that deviations need to be documented under API GMP.
  5. Process Validation: Undoubtedly the most critical section of GMP, because this is what qualifies and validates a process. It also carries important issues such as qualification vs. validation.
  6. Rejection and reuse of materials: Q 7 is perhaps the only document that precisely defines these terms. But for this, there would be considerable confusion about what we would be doing under API GMP.
  7. Agents: Outcome of the Haitian situation in the mid-1990’s, where children died from glycerubecontamination; this requires maintenance and traceability of records and processes from manufacturer to user.

 

API is the biologically activesubstance in a drug

A pharmaceutical drug consists of the API and the excipient, the inert substance

 

Introduction: Active Pharmaceutical Ingredient

An active pharmaceutical ingredient (API) is the substance in a pharmaceutical drug that is biologically active. Some medications may contain more than one active ingredient. The traditional word for the API is pharmacon or pharmakon which originally denoted a magical substance or drug.

Drug Ingredients

A drug in the dosage form consists of two ingredients: One is the API, which is the drug itself, this is the ingredient that treats or relieves the symptoms of the specific medical conditions; the second ingredient is a substance that acts as filler in order to give volume and substance to the tablet or drug. It is called as an excipient, which is the liquid the API is suspended in or is the substance of the tablet. The excipient is a pharmaceutically inert substance.

Every drug is defined based on its active pharmaceutical ingredient. It is important to understand the compatibility of API of one drug with that of the other, because when patients are on multiple medications, these API can interfere with each other. This could have effects ranging from minor side effects to serious repercussions such as life threatening complications.

Pharmaceutical Drugs vs. Herbal Medicines

The APIs are what differentiate a pharmaceutical drug from herbal medicines. In case of herbal medicines, the API are not identified, or there are more than one APIs and in most cases, these APIs although identified cannot be recreated through chemical or laboratory methods. This prevents standardization of herbal medicines; in many cases clinical trials do not provide substantial evidence of positive, or for that matter, any negative effect of a suspected API in herbal medicines.Thus further leads to complications in labeling. Due to non-existence of a standard dosage or identified API, the drug effects are interpreted haphazardly and lose objectivity.

Importance of API

APIs are the essence of pharmaceutical market and, for that matter, global healthcare. While there are several challenges faced by API manufacturing companies in terms of standardization and compliance requirements, there is equally good number of opportunities such as improved credibility and ability to penetrate global markets.

API Awareness

Due to the increased awareness of APIs, and their importance, potential effects and side effects, several online services have come up with information identifying the APIs in pharmaceutical medication. An example is the following website.  The authenticity of information on this website is not guaranteed.

 

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