Navigation Links
Genesis of SUPAC

Scale-UP and Post Approval Changes (SUPAC) is an integral part of pharmaceutical product development but till a few years ago, no guidance was available, to assure a smooth scale-up operation. US FDA was the first regulatory body to address this issue. //

Any pharmaceutical product developed by R&D team has to undergo various stages of scale-up from ‘laboratory-scale’ to ‘pilot-scale’ to ‘production-scale’ before it reaches the market. Scale-up process is an inherent part of overall product development activity and by virtue of variables involved poses a challenge to the product stability and performance. This makes scale-up a very critical component, which if not handled sensitively can undo all the R&D efforts.

Russo, in 1984 discussed the factors influencing the scale up process of various dosage forms. Factors such as variability of raw material, equipment differences, wet granulation effects, and compression press differences have been analysed for their role in scale-up process. The difficulties observed during scale-up of liquid formulations (sterilisation process) and for suppositories, which are quite dependent upon suppository making machines were also enumerated.

Pondell, in 1985 analysed the process variables involved in the film coating operation. Importance of factors like variation in supply of raw material and their response to processing and variation in instrumentation type. Problems crop up during scale up because at R&D scale the product is developed using fairly standard equipment and under controlled conditions compared to production level. The ultimate success of a product, to a great extent is determined by how easily and cost-effectively it can be commercialised.

'"/>




Page: 1

Related medicine news :

1. Acupuncture May Help Chemotherapy Side Effects
2. Antioxidants protect health tissue in people undergoing radiation therapy.
3. Distraction therapy found very effective in postoperative patients
4. Acupuncture superseeds massage therapy for short term relief of pain
5. Ovarian cancer in relationship with Hormone therapy
6. New therapy better at increasing bone density
7. Gene therapy - Aim to improve blood flow
8. Heat therapy relieves back pain
9. Radiotherapy helps in colon cancer
10. New therapy for pimples
11. Support therapy helps breast cancer patients
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/24/2016)... ... 2016 , ... Comfort Keepers® of San Diego, CA is excited to announce ... program to drive cancer patients to and from their cancer treatments. Comfort Keepers ... of life and ongoing independence. Getting to and from medical treatments is one ...
(Date:6/24/2016)... ... 2016 , ... People across the U.S. are sharpening their pencils and honing ... contest in which patients and their families pay tribute to a genetic counselor by ... Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute ... Dr. Barry M. Weintraub as a prominent plastic surgeon and the network’s newest ... world, and the most handsome men, look naturally attractive. Plastic surgery should be ...
(Date:6/24/2016)... Maryland (PRWEB) , ... June 24, 2016 , ... ... Angels is actively feeding the Frederick area economy by obtaining investment capital for ... over the past 2½ years that have already resulted in more than a ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) sponsors ... on June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, ... to helping service members that have been wounded in battle and their families. Venture ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016 ... the addition of the " Global Markets for ... This report focuses on ... updated review, including its applications in various applications. The ... which includes three main industries: pharmaceutical and biotechnology, food ...
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical ... the "Company"), which develops, markets and sells medical devices ... , signed a strategic cooperation agreement with Hongyuan ... "Hongyuan Supply Chain") on June 20, 2016, to develop ... the strategic cooperation agreement, Dehaier will leverage Hongyuan Supply ...
(Date:6/24/2016)... , June 24, 2016 ... Market by Type (Standard Pen Needles, Safety Pen Needles), ... (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) ... MarketsandMarkets, This report studies the market for the forecast ... to reach USD 2.81 Billion by 2021 from USD ...
Breaking Medicine Technology: