Research Journal of Pharmacy and Technology

Jay M. Jetani ¹, K. Girish Pai ¹

Affiliations
1 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, 576104, Karnataka State, IN

Abstract

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).

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B. S. Muddukrishna ¹, T. Vamshi Krishna ², Lalit Kumar ², K. Girish Pai ²

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

Abstract

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.

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Bahubali N. Patil ¹, Vamshi Krishna Tippavajhala ¹, K. Girish Pai ¹

Affiliations
1 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal -576104, Karnataka, State, IN

Abstract

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.

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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

Abstract

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.

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