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Girish Pai, K.
- A Comparative Review of the USFDA Guidelines on Process Validation Focusing on the Importance of Quality by Design (QbD)
Abstract Views :168 |
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Authors
Affiliations
1 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, 576104, Karnataka State, IN
1 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, 576104, Karnataka State, IN
Source
Research Journal of Pharmacy and Technology, Vol 10, No 4 (2017), Pagination: 1257-1260Abstract
Medical disasters like Devonport incident of 1972 in Liverpool, United Kingdom, where many patients were killed due to administration of improperly sterilized dextrose infusions, led the USFDA to release its first guidance on Process Validation in 1987. However, the FDA's 1987 guidance document, Guideline on General Principles of Process Validation was replaced in January of 2011 when the FDA published the updated guidance for Industry-Process Validation: General Principles and Practices. The new guideline introduces new concepts and principles and denotes the evolution in process validation requirements. The new approach provides opportunities for a more integrated approach to process validation and across the product lifecycle. It also provides opportunities for automation of the collection, processing, and reporting of the required information. Like other guidelines, they are not law, but adherence to them provides a good framework for building a compliance program and developing a quality medicinal product.Keywords
Process Validation, Quality by Design (QbD), USFDA, Life-Cycle Approach, Process Performance Qualification (PPQ).- Importance of Competency Level and its Assessment in Pharmaceutical Industry
Abstract Views :183 |
PDF Views:0
Authors
Affiliations
1 Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal -576104, Karnataka State, IN
2 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal -576104, Karnataka State, IN
1 Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal -576104, Karnataka State, IN
2 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal -576104, Karnataka State, IN
Source
Research Journal of Pharmacy and Technology, Vol 11, No 1 (2018), Pagination: 139-142Abstract
Both competency level and training plays a major role in pharmaceutical industries. Pharmaceutical industry employs technical people from various streams or fields like graduates and post graduates in pharmacy, engineering, science, management etc. On one hand, competency or basic education is a prerequisite for recruiting technical staff to perform assigned job, on the other hand, training the graduates from various streams is an important task for the pharmaceutical industry. Training and development is an ongoing or routine activity in pharma industry so that both the pharma companies and technical staff are up to date and meet the regulatory requirements as per norms. Even the competency level needs to be improved from time to time, like new generation smart phones, where in we need to update our smart phone to include new features or upload new software’s. If this is not done, we become outdated. Likewise, in pharmaceutical industries, both competency level and training and development go parallelly and complimentary to each other. With regulatory agencies (FDAs) becoming increasingly stringent, both competency and training have become integral part of today’s cGMP systems. Therefore, to make the technical staff more competent and well trained, this article gives a detailed insight into competency level and training and development.Keywords
Competency, Competency Level, Job Responsibility and cGMP.References
- http://pdf.usaid.gov/pdf_docs/PA00JGFN.pdf.Accessed on 11/27/2016.
- https://en.wikipedia.org/wiki/Competence. Accessed on 01/12/2016.
- https://hr.od.nih.gov/workingatnih/competencies/proficiencyscale.htm Accessed on 21/12/2016.
- http://www.aspiringminds.com/featured-profiles/pharmaceutical-trainee-entry-level-0. Accessed on 27/01/2017.
- Equipment Qualification of a New Laboratory Tray Dryer
Abstract Views :171 |
PDF Views:0
Authors
Affiliations
1 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal -576104, Karnataka, State, IN
1 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal -576104, Karnataka, State, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 2 (2019), Pagination: 805-811Abstract
This qualification study deals with the Installation and Qualification of a New Tray Dryer. Granules in the pharmaceutical industry are dried using the different equipment like Fluid Bed Dryer, Belt Dryer, Tray Dryer, Vacuum Tray Dryer, Spray Dryer and Rotary Dryer. In this case, the study was conducted on the newly installed laboratory Tray Dryer. Various documentation requirements like User Requirement Specification, Factory Acceptance Test, Site Acceptance Test, Installation Qualification, Operational Qualification and Performance Qualification were carried out for the equipment. Calibration of measuring devices, the prepared granules were dried using the tray drier and noted the time required to dry the granules. Equipment qualification of newly installed laboratory Tray Dryer was performed meeting all the qualification parameters.Keywords
Tray Dryer, User Requirement Specification, Installation Qualification, Operational Qualification and Performance Qualification.References
- Pharmaceuticalmachinery.in; Shree Bhagwati Pharma Machinery Company, an ISO 9001:2000 company. http://www.pharmaceuticalmachinery.in/pharmaceutical_processing_machineries.htm#tray_dryer_pharmaceutical_machine. Accessed on 16-08-2017.
- Pharm Technology Index, A Technological Platform and market Place; http://www.pharmatechnologyindex.com/Category/tray-dryer. Accessed on 29-11-2017.
- Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations; https://www.fda.gov/downloads/Drugs/Guidances/UCM070337.pdf. Accessed on 16-08-2017.
- Suhaimi M. Review on the application of a tray dryer system for agricultural products. World applied sciences journal. 2013 May 12;22(3):424-33.
- Jatto E, Okhamafe AO. An Overview of Pharmaceutical Validation and Process Controls in Drug Development. Tropical Journal of Pharmaceutical Research. 2002;1(2):115-22.
- urswriter.com; Defining Requirements for Process Automation; http://www.urswriter.com/index.html?UserRequirements. Accessed on 16-08-2017.
- McDowall R. Validation of chromatography data systems. Royal Society of Chemistry; 2016 Nov 23. 303-318.
- theprojectdefinition.com; https://www.theprojectdefinition.com/?s=Factory+acceptance+test. Accessed on 19-08-2017.
- theprojectdefinition.com; https://www.theprojectdefinition.com/?s=Site+acceptance+test. Accessed on 16-08-2017.
- ofnisystems.com; Ofni Systems; http://www.ofnisystems.com/services/validation/. Accessed on 17-08-2017.
- Chaloner-Larsson, Gillian, Roger Anderson, Anik Egan, Manoel Antonio Da Fonseca Costa Filho, Jorge F. Gomez Herrera, and World Health Organization. (1999) "A WHO guide to good manufacturing practice (GMP) requirements." Part 2: Validation, pp 36-52.
- Solubility and Dissolution Improvement of Carbamazepine by Various Methods
Abstract Views :395 |
PDF Views:0
Authors
Shreya
1,
Ayesha Heena
1,
Ranjitha
1,
Amrutha A. Shetty
1,
Chetan H. Mehta
1,
Usha Y. Nayak
1,
Srinivas Mutalik
1,
K. Girish Pai
1
Affiliations
1 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, IN
1 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 7 (2019), Pagination: 3333-3337Abstract
This work was aimed to improve solubility and dissolution rate of carbamazepine (CBZ), an antiepileptic, BCS class II drug by using different solubility enhancement techniques. Self-nanoemulsifying drug delivery system (SNEDDS) and solid dispersions of CBZ was attempted by spontaneous emulsification method and fusion method, respectively. The solubility studies of pure CBZ was performed in different oils, surfactants and co-surfactants. Very small amount of CBZ (20 mg) could be incorporated in SNEDDS, however the solid dispersion of CBZ using Soluplus® was successfully prepared with the required dose. The solid dispersion was characterized and evaluated for saturation solubility, in vitro dissolution studies, solid state characterization such as fourier transform infrared spectroscopy (FTIR) and powder X-ray diffraction studies (XRD). Based on the results, it can be concluded that the due to increased solubility and the dissolution, the bioavailability of CBZ could be improved by preparing solid dispersion.Keywords
Carbamazepine, Self-Nanoemulsifying Drug Delivery System, Solid Dispersion, Spontaneous Emulsification Method, Fusion Method.References
- Sander JW. The Natural History of Epilepsy in the Era of New Antiepileptic Drugs and Surgical Treatment. Epilepsia. 2003, 44(s1): 17–20.
- Mills A. Global comparative assessments in the health sector: Disease burden, expenditures and intervention packages. Vol. 89, Transactions of the Royal Society of Tropical Medicine and Hygiene. Oxford University Press, 1995 [cited 2018 Nov 8]. p. 578.
- Zybina A, Anshakova A, Malinovskaya J, Melnikov P, Baklaushev V, Chekhonin V, et al. Nanoparticle-based delivery of carbamazepine: A promising approach for the treatment of refractory epilepsy. International Journal of Pharmaceutics. 2018, 547(1–2): 10–23.
- Acharya SP, Pundarikakshudu K, Panchal A, Lalwani A. Preparation and evaluation of transnasal microemulsion of carbamazepine. Asian Journal of Pharmaceutical Sciences. 2013, 8(1): 64–70.
- Kou W, Cai C, Xu S, Wang H, Liu J, Yang D, et al. In vitro and in vivo evaluation of novel immediate release carbamazepine tablets: Complexation with hydroxypropyl-β-cyclodextrin in the presence of HPMC. International Journal of Pharmaceutics. 2011, 409(1–2): 75–80.
- Kalepu S, Nekkanti V. Insoluble drug delivery strategies: review of recent advances and business prospects. Acta Pharmaceutica Sinica B. 2015, 5(5): 442–453.
- Wang L, Dong J, Chen J, Eastoe J, Li X. Design and optimization of a new self-nanoemulsifying drug delivery system. Journal of Colloid and Interface Science. 2009, 330(2): 443–448.
- Park M-J, Ren S, Lee B-J. In vitro andin vivo comparative study of itraconazole bioavailability when formulated in highly soluble self-emulsifying system and in solid dispersion. Biopharmaceutics & Drug Disposition. 2007, 28(4): 199–207.
- Jeevana Jyothi B, Sreelakshmi K. Design and Evaluation of Self-Nanoemulsifying Drug Delivery System of Flutamide.Journal of Young Pharmacists. 2011, 3(1): 4–8.
- Pouton CW. Lipid formulations for oral administration of drugs: non-emulsifying, self-emulsifying and “self-microemulsifying” drug delivery systems. European Journal of Pharmaceutical Sciences. 2000, 11 Suppl 2: S93-98.
- Fatouros DG, Karpf DM, Nielsen FS, Mullertz A. Clinical studies with oral lipid based formulations of poorly soluble compounds. Therapeutics and Clinical Risk Management. 2007, 3(4): 591–604.
- Chakraborty S, Shukla D, Mishra B, Singh S. Lipid – An emerging platform for oral delivery of drugs with poor bioavailability. European Journal of Pharmaceutics and Biopharmaceutics. 2009, 73(1): 1–15.
- Maulvi FA, Dalwadi SJ, Thakkar VT, Soni TG, Gohel MC, Gandhi TR. Improvement of dissolution rate of aceclofenac by solid dispersion technique. Powder Technology. 2011, 207(1–3): 47–54.
- Shamsuddin, Fazil M, Ansari SH, Ali J. Development and evaluation of solid dispersion of spironolactone using fusion method. International Journal of Pharmaceutical Investigation. 2016, 6(1): 63–68.
- Nan Z, Lijun G, Tao W, Dongqin Q. Evaluation of Carbamazepine (CBZ) Supersaturatable Self-Microemulsifying (S-SMEDDS) Formulation In-vitro and In-vivo. Iranian Journal of Pharmaceutical Research. 2012, 11(1): 257–264.
- Sethia S, Squillante E. Physicochemical Characterization of Solid Dispersions of Carbamazepine Formulated by Supercritical Carbon Dioxide and Conventional Solvent Evaporation Method. Journal of Pharmaceutical Sciences. 2002, 91(9): 1948–1957.
- Milović M, Djuriš J, Djekić L, Vasiljević D, Ibrić S. Characterization and evaluation of solid self-microemulsifying drug delivery systems with porous carriers as systems for improved carbamazepine release. International Journal of Pharmaceutics. 2012, 436(1–2): 58–65.
- Biswas M, Akogyeram CO, Scott KR, Potti GK, Gallelli JF, Habib MJ. Development of carbamazepine: phospholipid solid dispersion formulations. Journal of Controlled Release. 1993, 23(3): 239–245.
- Djuris J, Nikolakakis I, Ibric S, Djuric Z, Kachrimanis K. Preparation of carbamazepine–Soluplus® solid dispersions by hot-melt extrusion, and prediction of drug–polymer miscibility by thermodynamic model fitting. European Journal of Pharmaceutics and Biopharmaceutics. 2013, 84(1): 228–237.
- Lee J-Y, Kang W-S, Piao J, Yoon I-S, Kim D-D, Cho H-J. Soluplus®/TPGS-based solid dispersions prepared by hot-melt extrusion equipped with twin-screw systems for enhancing oral bioavailability of valsartan. Drug Design, Development and Therapy. 2015, 9: 2745–2756.
- Balakumar K, Raghavan CV, selvan NT, prasad RH, Abdu S. Self nanoemulsifying drug delivery system (SNEDDS) of Rosuvastatin calcium: Design, formulation, bioavailability and pharmacokinetic evaluation. Colloids Surfaces B: Biointerfaces. 2013; 112: 337–343.
- Medarević DP, Kachrimanis K, Mitrić M, Djuriš J, Djurić Z, Ibrić S. Dissolution rate enhancement and physicochemical characterization of carbamazepine-poloxamer solid dispersions. Pharmaceutical Development and Technology. 2016, 21(3): 268–276.