Monday, June 11, 2012

P.R. China - Good Manufacturing Practice for Drugs (2010 Revision) - In English - Free

Updated March 24, 2020

The link in the original post broke.

You might also be interested in:
Chinese and English Translation GMPs - 
SFDA Good Manufacturing Practice for Drugs (2010 Revision) ( MOH Decree No. 79 )

- - -  the original post follows below  - - -

The Good Manufacturing Practice for Drugs (2010 Revision), adopted at the executive meeting of the Ministry of Health on October 19, 2010, is hereby promulgated and shall go into effect as of March 1, 2011.

The document has 43 pages and is divided into 14 chapters with 313 paragraphs.

The link below takes you to the free English language version of the doucment.

State Food and Drug Administration, P.R.China (SFDA) - Ministry of Health (MOH) Decree No. 79 - Good Manufacturing Practice for Drugs (2010 Revision):

"Article 1: These provisions of Good Manufacturing Practice (GMP) for Drugs, in accordance with the Drug Administration Law of the People’s Republic of China and the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, are enacted to regulate the manufacturing and quality management of Drugs."

'via Blog this'


Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Saturday, June 9, 2012

FDA delays decision on drug to prevent HIV

The FDA is delaying a decision on whether to approve a drug for preventing infection with HIV, for 3 more months.

FDA delays decision on drug to prevent HIV - The Washington Post:

"In May, a committee of FDA advisers recommended that the agency approve Truvada for HIV prevention in specific high-risk groups, including men who have sex with men and partners of those infected with HIV.

After that meeting, the FDA asked Gilead to revise its risk-management plan for the drug, Miller said.

She declined to provide details on how Gilead revised this plan, which is known as a risk evaluation and management strategy."

'via Blog this'

If approved, Truvada would become the first drug marketed for prevention of HIV. The FDA will now make a decision by Sept. 14.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

New Wave of Cancer Combo Drugs Coming With Fewer Side Effects

New Wave of Cancer Combo Drugs Coming With Fewer Side Effects:

"A new wave of more-accurately targeted and less-toxic cancer fighting drugs that involve armed antibodies is on the horizon now, based upon a presentation made last weekend at the American Society of Clinical Oncology.

Side effects should be lessened and lives prolonged by this latest class of cancer drugs, which should translate well for patients with mesothelioma, the aggressive cancer caused by an exposure to asbestos."

'via Blog this'

Friday, June 8, 2012

FDA Form 483 Can Form Basis of Class Action Lawsuit

In the long list of things that are inadvisable to regulatory professionals, making misleading statements to the authority in charge of regulating your business likely ranks near the top. Those found to have misled the US Food and Drug Administration (FDA) have in the past been publicly warned, fined, imprisoned, shut down and barred from participating in federal programs.

Now KV Pharmaceuticals is facing the prospect of an additional action: a class-action shareholder lawsuit as the result of an FDA inspection report.

Judge: Regulatory Inspection Report Can Form Basis of Class Action Lawsuit - RAPS - News - Article View:

"On Monday, 4 June a federal appeals court ruled a securities fraud class action lawsuit could proceed against pharmaceutical manufacturer KV Pharmaceuticals for purportedly causing $1.5 billion in shareholder losses after first misleading FDA about manufacturing problems at a facility and later shutting down the facility’s manufacturing operations."

'via Blog this'

What's important to note is that this decision is a marked reversal from existing precedence, which has found Form 483 reports to be immaterial to federal securities law.

You might also be interested in:
Surviving an FDA Inspection - Recommended QSR & GMP Training by SkillsPlus International Inc.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Wednesday, June 6, 2012

How Human Factors Lead to Medical Device Adverse Events

A nicely written article on "Human Factors."

How Human Factors Lead to Medical Device Adverse Events « QD Syringe Systems™:

"The complexity and diversity of medical devices used simultaneously contribute to human factors errors. A key objective of human factors in medical device design is to enhance the likelihood of good performance under less-than-ideal conditions. To minimize human factors problems, devices should be designed according to users’ needs, abilities, limitations, and work environments. This includes the design of the device’s user interface, which includes controls, displays, software, labels, and instructions—anything the user may need to operate and maintain a device."

'via Blog this'

You might also be interested in:
The Human Factors Program at FDA

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

From SkillsPlus International Inc.