Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations #pharma #agencies

Posted On Jun 14 2017 by

#drug manufacturer # Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations Introduction FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have. The approval process for new drug and generic drug marketing applications includes a review of the manufacturer’s compliance with …


Facts About the Current Good Manufacturing Practices (CGMPs) #qrx #pharma

Posted On Jun 14 2017 by

#pharmaceutical manufacturing process # Facts About the Current Good Manufacturing Practices (CGMPs) Pharmaceutical quality affects every American. FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of CGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on …


EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines #janssen #pharma

Posted On May 17 2017 by

#gmp pharma # European Commission Public health EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines. Volume 4 of “The rules governing medicinal products in the European Union” contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively. Introduction Introduction (33 KB) (7/02/2011) Commission Directive 2003/94/EC. of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human …


Pharmaceutical Sales FAQ: Is it good to work for a contract company? #shire #pharma

Posted On May 17 2017 by

#contract pharmaceutical companies # Q:Should I accept a contract sales position if my real goal is to work directly for a drug company?A: That’s a matter of personal choice. Contract reps are highly regarded, although the pay and prestige level may not be as high at first. Working as a contract rep could be a great transition into your job of choice. Contract reps that are good workers have the perfect opportunity to network their way into their dream-job. They can wait and choose the perfect territory rather than grab the first opening that comes up like you and me. …


Even for busy doctors, nothing is as good as a rep – for getting pharma

Posted On May 15 2017 by

#pharma info # Even for busy doctors, nothing is as good as a rep for getting pharma info If you’re a pharma sales rep, chances are, you’re walking through a fog of existential angst. If you’re not questioning your existence, worrying that you’ll be laid off, or wondering whether the doctors in your territory will stop seeing reps, you know other reps who are. All the surveys and studies–doctors like seeing reps, doctors prefer to read, doctors are unduly influenced, doctors aren’t, e-detailing will or won’t replace reps–probably don’t help, either. But you’ve probably been around long enough to have …


India – s Pharmaceutical industry is on a good growth path, but will have to

Posted On May 14 2017 by

#future of pharmaceutical industry # India’s Pharmaceutical industry is on a good growth path, but will have to watch out for the regulatory interventions The Indian pharma industry is on a good growth path and is likely to be in the top 10 global markets in value term by 2020. according to the PwC – CII report titled “India Pharma Inc: Gearing up for the next level of growth”. High burden of disease, good economic growth leading to higher disposable incomes, improvements in healthcare infrastructure and improved healthcare financing are driving growth in the domestic market, the report highlighted. The …


Pharmaceutical Sales FAQ: Is it good to work for a contract company? #pharma #licensing #deals

Posted On Apr 30 2017 by

#contract pharmaceutical companies # Q:Should I accept a contract sales position if my real goal is to work directly for a drug company?A: That’s a matter of personal choice. Contract reps are highly regarded, although the pay and prestige level may not be as high at first. Working as a contract rep could be a great transition into your job of choice. Contract reps that are good workers have the perfect opportunity to network their way into their dream-job. They can wait and choose the perfect territory rather than grab the first opening that comes up like you and me. …


Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations #mayne #pharma

Posted On Apr 29 2017 by

#drug manufacturer # Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations Introduction FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have. The approval process for new drug and generic drug marketing applications includes a review of the manufacturer’s compliance with …


EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines #leading #pharmaceutical #companies #2013

Posted On Apr 21 2017 by

#gmp pharma # European Commission Public health EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines. Volume 4 of “The rules governing medicinal products in the European Union” contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively. Introduction Introduction (33 KB) (7/02/2011) Commission Directive 2003/94/EC. of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human …


Facts About the Current Good Manufacturing Practices (CGMPs) #biotechnology #industry

Posted On Apr 20 2017 by

#pharmaceutical manufacturing process # Facts About the Current Good Manufacturing Practices (CGMPs) Pharmaceutical quality affects every American. FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of CGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on …