Ram Gopal College of Pharmacy

Approved by- AICTE, PCI, MHRD, Govt of India,
Affiliation from Pt. B.D. Sharma University of Health Science, Rohtak, Haryana
State Government University

News  | Articles  | Login | Contact us | Enquiry Form


helpline

Enquiry Form :


Name *
Email *
Mobile *
Address *
Course *
Message *
Notification

  • Admission Open 2017-18
  • PCI Approved College
  • Last date of Submission of Form
  • Campus placement is a routine.
  • Facilities at RGCP
    RGCP Pharmacy College in Delhi NCR

    The institute provides with transport facility from all parts of delhi and Gurgaon.


    Admission open for 2017-18 M.Pharmacy (Pharmaceutics), B.Pharmacy - LEET Limited Seats Available

    Articles

    Quality by Design (QbD) – An Essential Aspect of modern drug development

    Quality by design is an essential part of the modern approach to pharmaceutical quality. Quality by Design (QbD) is a modern, scientific approach which helps in finalizing drug design, alignment of troubleshooting and automates manual testing. Quality by Design (QbD) approach helps in ensuring quality by developing a thorough understanding of the compatibility of a finished product to all of the components and processes involved in manufacturing.

    Majority of the quality issue can be efficiently analyzed by using Quality by Design (QbD) approach. This technique provides insights upstream throughout the development process. QbD requires identification of all critical formulation attributes and process parameters as well as determining the extent to which any variation can impact the quality of the finished product.


    Basic components of Quality by Design (QbD) involve a) Defining the Product Design Goal b) Discovering the Process Design Space. C) Understanding the Control Space. D). Targeting the Operating Space.

    Some of the important tool of QbD includes design of experiments (DOE), risk assessment and process analytical technology (PAT).

    QbD development process involve following step:

    • Targeting of product profile: describes the use, safety and efficacy of the product.
    • Target product quality profile: for defining the quantitative aspects of clinical safety and efficacy during product development
    • Knowledge of prior art:   Helps in risk assessment to prioritize knowledge gaps for further investigation.
    • Critical quality attributes: Design a formulation and identify the critical quality attributes of the final product that must be controlled to meet the target product quality profile. Design a manufacturing process to produce a final product having these critical quality attributes.
    • Identification of critical process parameters and raw material attributes which can be used for controlling the critical material attributes of the final product.
    • Establish a control strategy for the entire process that may include input material controls, process controls and monitors, design spaces around individual or multiple unit operations, and/or final product tests.
    • Continually monitor and update the process to assure consistent quality.

    Implementing QbD beginning at the development phase requires a dedicated, disciplined, and sustained commitment by an organizattion. Few major challenges related to QbD design includes insufficient understanding of the process and its benefits, organizational resistance to change, denial of the need, competing priorities and lack of resources and expertise.

    FDA emphasis for the requirement of QbD design can be easily judged by frequent deficiency letters citing the lack of QbD.   Pharmaceutical industries are frequently citing critical components of QbD such as Quality target product profile (QTPP), critical quality attributes (CQAs), critical material attributes of drug and excipients (CMAs) and critical process parameters (CPPs).

    Quality by Design (QbD) approach can results in reduced development time and costs, more regulatory compliance and reduction in queries from regulatory agencies. This approach helps in the reduction of failures results during the shelf life of the product. Quality control testing of the product may results in failure due to non-compliance of specification or lack of robust manufacturing process.

    References:-

    1.       ICH. Draft consensus guideline: pharmaceutical development annex to Q8. Available at:, http://www.ich.org/LOB/media/MEDIA4349.pdf (accessed 11/21/2007).

    2.       J. Woodcock. The concept of pharmaceutical quality. Am. Pharm. Rev.Nov/Dec 2004: pp. 1–3.

    3.       P. Ganzer, J. A. Materna, M. B. Mitchell, and L. K. Wall. Current thoughts on critical process parameters and API synthesis. Pharm. Technology.46–66 (2005), July.

    4.       M. Glodek, S. Liebowitz, R. McCarthy, et al. Process robustness: A PQRI white paper. Pharm. Eng.1–11 (2006), Nov/Dec

    5.       ISPE PQLI. Draft PQLI summary update report. http://www.ispe.org/cs/pqli_product_quality_lifeycle_implementation_/draft_pqli_summary_update_report (accessed 11/21/2007).

    6.       M. N. Nasr. Implementation of quality by design (QbD): status, challenges, and next steps. FDA Advisory Committee for Pharmaceutical Science. Available at: http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s1_6.ppt (accessed 11/21/2007).

    7.        L. X. Yu. Implementation of quality-by-design: OGD initiatives. FDA Advisory Committee for Pharmaceutical Science. Available at: http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s1_8.ppt (accessed 11/21/2007).

    College Address

    College At:- Near Sultanpur Bird Sanctuary,
    Farrukhnagar, Distt.- Gurgaon, Haryana
    Phone:- 011-47048220

    Email:- info@ramgopalcollege.com

    Head Office

    A1/11, Prashant Vihar Rohini,
    C/o Little Planet Preschool
    Near Pitampura Metro Station,Opposite Power House
    New Delhi, India-110085

    Copyright © 2005-2016 Ram Gopal Colllege of Pharmacy. All rights reserved.