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:

(Date:6/25/2016)... ... June 25, 2016 , ... Experts ... applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes Convention ... health care topics including advance care planning, healthcare costs and patient and family ...
(Date:6/25/2016)... ... 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned ... the David Geffen School of Medicine at UCLA. He trained in Internal Medicine at ... fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may ... to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To ... for healthy coping following a traumatic event. , Trauma sufferers tend to feel a ...
(Date:6/24/2016)... Francisco, CA (PRWEB) , ... June 24, 2016 ... ... CitiDent, is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive ... self-ligating Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute Beauty Network, ... M. Weintraub as a prominent plastic surgeon and the network’s newest partner. ... the most handsome men, look naturally attractive. Plastic surgery should be invisible.” He ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , Belgium , June ... MKT: VNRX), today announced the appointment of Dr. ... of Directors as a Non-Executive Director, effective June ... Company,s Audit, Compensation and Nominations and Governance Committees.  ... Dr. Futcher will provide independent expertise and strategic ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
(Date:6/23/2016)... June 23, 2016 Any dentist who has made ... the current process. Many of them do not even offer ... difficulties and high laboratory costs involved. And those who ARE ... at such a high cost that the majority of today,s ... Dr. Parsa Zadeh , founder of Dental Evolutions Inc. ...
Breaking Medicine Technology: