RT Journal Article
SR Electronic
T1 A Semi- Quantitative Risk Assessment Methodology Fit for Bio-Pharmaceutical Lifecycle Stages
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2019.010173
DO 10.5731/pdajpst.2019.010173
A1 Ajay Babu Pazhayattil
A1 Naheed Sayeed-Desta
A1 Shu Chen
A1 Marzena Ingram
YR 2020
UL http://journal.pda.org/content/early/2020/02/14/pdajpst.2019.010173.abstract
AB This paper introduces an innovative risk assessment tool, a semi-quantitative risk determination (SQRD) method designed to address risk on the operational and organizational level with a distinct patient safety perspective. Quality risk management (ICH Q9) is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. SQRD is a systematic data driven risk assessment tool. It is of practical significance to have a risk assessment tool that directly links to patient safety attributes. The SQRD methodology has five distinctive steps that are customized to address patient impact and non-patient impact quality attributes. The target was to develop and utilize an advanced risk assessment tool that is reliable, robust, objective and data-driven. SQRD can be applied to batch production, continuous process, or a hybrid of the two, and at any stage of the product lifecycle such as early development, pilot formulation development, process validation or commercial manufacturing. The output of SQRD can help in shaping and optimizing the product control strategy. The exercise enables systematic mitigation of the identified risks. The proposed semi-quantitative risk determination (SQRD) tool systematically evaluates data and scientifically establishes reliable, robust and efficient risk assessments.