Friday, April 25, 2014

FDA - Product Requirements, Marketing & Labeling > Extending Authorities to Additional Tobacco Products

Product Requirements, Marketing & Labeling > Extending Authorities to Additional Tobacco Products - FDA:

"Currently FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. Proposed newly “deemed” products would include electronic cigarettes, cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco.

Once the proposed rule becomes final, FDA will be able to use powerful regulatory tools, such as age restrictions and rigorous scientific review of new tobacco products and claims to  reduce tobacco-related disease and death."

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Friday, April 18, 2014

Regulatory Explainer: Why and How is FDA Regulating Mobile Apps? - Regulatory Focus

Regulatory Explainer: Why and How is FDA Regulating Mobile Apps? - Regulatory Focus:

"In Brief, What's This Issue About?

In the US, the Food and Drug Administration (FDA) regulates many products to ensure that they are safe and effective, including medical devices such as wheelchairs and pacemakers. However, the definition of "medical device" also includes software, and in recent years FDA has moved to regulate software found on mobile phones, what most people refer to as "mobile apps."

Critics have raised the point that strict regulation of medical mobile apps could stifle innovation in the sector, while others have pointed to spurious or faulty apps to make the point that regulation is sorely needed."

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Wednesday, April 16, 2014

Hamburg to PhRMA: If you don't have quality, the rest doesn't matter - FiercePharma

Hamburg to PhRMA: If you don't have quality, the rest doesn't matter - FiercePharma:

"she said, high-risk products like sterile injectables need to be produced with proper attention for sterile procedures. Advances in science and technology can make a difference, too: Pharma can use quality by design, continuous manufacturing and other approaches to help improve both quality and efficiency in the production process, rooting out preventable problems that create shortages and compromise patient trust.

"It's just so fundamentally important," she said. "If you don't have quality, all the rest of it really doesn't matter.""

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Wednesday, April 9, 2014

GMP Trainers - Ensure That They Are Qualified Individuals

GMP trainers must be "qualified individuals," according to 21 CFR 211 Subpart B.

Do you want to make sure your GMP trainers are qualified?

If you said yes, then consider this highly recommended course:
CGMP/QSR Trainer Certification Program - May 5-9, 2014 - Public Seminar in Fort Lauderdale, FL

Reference:  21 CFR 211 Subpart B:
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL
PART 211 -- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart B--Organization and Personnel
Sec. 211.25 Personnel qualifications.
(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
(b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.
(c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.

You might also be interested in:
GMP Trainer Certification Workshop - May 5-9, 2014 Public Seminar - Fort Lauderdale, FL
Surviving An FDA Inspection - a GMP Training Course

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