Quality Risk Management in Pharmaceutical Industry: A Review

life cycle, quality risk management (QRM) is a Quality Risk Management comprehensive and ongoing (QRM) has been a mandated process that aims to minimize regulatory obligation for risks to the product's quality while healthcare businesses for the past balancing the associated hazards. few years (1). Throughout a product's It follows a methodical procedure for identifying, managing, sharing, and reviewing risks to the pharmaceutical product's quality. It supports science based and practical decisions when integrated into quality systems, examples of quality systems include Validation, Quality Defects- Investigation, Auditing, Inspection, Documentation, Training etc.(1) Quality Risk Management principles are effectively utilized in many areas including business, insurance, work related safety, public health, pharmacovigilance, and by agencies regulating these industries (2). Even though there are some examples of the use of quality risk management in the pharmaceutical industry, today they are limited and do not represent the full contributions that risk management has to offer. In relation to pharmaceuticals, though there are a variety of stakeholders, including medical practitioners and patients as well as government and industry, the safety of the patient by managing the risk to quality should be considered prime importance. The manufacturing and use of a drug product, including its components, necessarily involve some degree of risk. Use of QRM can ameliorate the decision making If quality problem arises.(3)

2.Defining Risk:   

Preliminary working definitions from ICH EWG on QRM Q9:  

Risk :- Combination  of  the  probability  of  occurrence  of  Harm and the severity of that harm. ISO 14971. 

Harm :-Damage to health, including the damage that can occur from loss of product efficacy, safety, Quality or availability.  

Quality:-Degree to which a set of inherent characteristics of a product, system or process fulfils requirements.  

Requirements :- Needs or expectations that  is stated, generally implied  or  obligatory  by  the patients or  their  Surrogates (e.g.  health care professionals, regulators and legislators). 

Combining key terms :-  Risk  to quality is the  probability/severity   that   drug will   fail   to   meet   the  needs/expectations of  the  patients  and  their  surrogates.(4)

3. Quality Risk Management:

English Quality risk management has become an important issue in quality management in many manufacturing functions. It is a project management tool and a key element of quality by design. ICH Q9 introduced quality risk management (QRM) guidelines which were adopted in November 2005 (Vesper and O Donnell, 2016). However, Donnell and Greene (2007) developed a practical QRM approach to facilitate compliance with EU Good Manufacturing Practice (GMP) requirements and the ICH Q9 guideline. The researcher called for further efforts to promote the continued development of environmental QRM (GMP) methods and approaches to minimize and manage risks posed by medicines to patients. In 2008, Frank et al. (4) (2011) demonstrates the efforts of the Risk Management Working Group in assembling industry case studies aimed at improving the understanding and application of ICH Q9, including n of eight industry representatives and the US FDA. They demonstrate the need to select the appropriate risk methodology for the target need, taking into account the complexity and risks associated with the specific issue and the importance of predetermining the potential risk classification so as not to be influenced by the outcome of the assessment when determining the appropriate response.2013, practical means for analyzing quality risks. machine had been defined through Lotllikar MV who supplied guidance long side the manner to acquire powerful nice control and compliance thru QRM, the paper concluded that when making use of chance control to pharmaceutical enterprise it will lessen the quantity of threats or reduce their effect the constant use of the tools/techniques and periodic review, the output of the chance control helps the corporation to meet the described dreams closer to safety of public health (Lotllikar, 2013) (4). As Muhammad and Rehana (2014) proved that QRM improves chance consciousness and hastens detection of potential problems the usage of nice statistics to control product nice, production tactics and compliance inside a chance primarily based totally Quality Management System, the very last item will make certain the excessive nice of the drug product to the patient .According to Haleem et al. (2015), chance Management is a vital nice subjects won the unique difficulty in chemical and pharmaceutical nice assurance, they invited each managers on the pharmaceutical enterprise and  literature to recognition at the adoption of practices like lean production, Six Sigma and overall nice control into the pharmaceutical enterprise to reduce the opportunity of QRM. Kumar and Jha (2018) admitted that there are instances of unresolved client court cases and batch disasters originated due to inadequacies all through distribution of pharmaceutical Products, they added a version to lessen the product rejection the usage of Risk.