What is quality?
It is a multifaceted question, difficult to answer in the abstract. Four fitness that explains the evolution process of quality is
1. Fitness to standard
2. Fitness to use
3. Fitness to cost
4. Fitness to the latent requirement
ISO 9000:2000 and international standard on quality vocabulary define as:
The degree to which a set of inherent characteristics fulfills the requirement.
The Americans who brought the messages of quality to Japan and the rest of the world. Prominent figures lying on the group are W. Edwards Deming, Joseph M Juran, Philip Crosby
Japanese who developed new concepts to the American messages. Prominent figures lying on this group are: Kaoru Ishikawa, Sigeo Shingo, Yoshio Kondo
Quality Control and Quality Assurance
Quality control is a subset of Quality Assurance
“Quality assurance” is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use.
Quality Assurance is all those planned and systemic actions necessary to provide confidence that an entity will fulfill requirements for quality. It is a process of creating standards thorough planning. Assurance comes through the knowledge of what will be, is being, of has been done, rather than doing it. The means to provide the confidence, assurance need to build into the process, such as documenting plans, documenting specifications, creating records, reporting reviews etc. Such documents and activities also serve to control quality as well as assure it. ISO 9001 is a quality assurance standard, designed for use in assuring customers that suppliers have a capacity of meeting their requirements. Quality assurance also incorporates Good manufacturing practices (GMP) and other factors.
Quality control is operational techniques and activities which are used to fulfill requirements of quality. It is a process of maintaining standards. It prevents the undesirables changes in the quality of product or service being supplied. If you do not have control quality products are produced by chance not design.
What is risk?
It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm.
In relation to pharmaceuticals, although there are a variety of stakeholders, including patients and medical practitioners as well as government and industry, the protection of the patient by managing the risk to quality should be considered of prime importance.
It is important to understand that product quality should be maintained throughout the product lifecycle such that the attributes that are important to the quality of the drug product remain consistent with those used in the clinical studies. An effective quality risk management approach can further ensure the high quality of the drug product to the patient by providing a proactive means to identify and control potential quality issues during development and manufacturing.
Product Lifecycle: 1. Introduction, 2. growth, 3. maturity, 3. Decline
What is quality risk management?
Quality risk management (QRM) can improve the decision-making if a quality problem arises. Effective QRM can facilitate better and more informed decisions, can provide regulators with greater assurance of a company’s ability to deal with potential risks, and can beneficially affect the extent and level of direct regulatory oversight.
Quality risk management specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, by both regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle.
Tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, inspection, and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging and labeling materials in drug products, biological and biotechnological products).
Primary Principles of Risk Management
· The evaluation of the risk to quality should be based on scientific knowledge & ultimately link to the protection of the patient and
· The level of effort, formality & documentation of the quality risk management process should be commensurate with the level of risk.
Principles and common practices
Core principles of quality risk management according to the ICH Q9 guideline include the following: International Conference on Harmonization (ICH) provides an excellent high-level framework for the use of risk management in pharmaceutical product development and manufacturing quality decision-making applications
1. Compliance with applicable laws: Risk assessment should be used to assess how to ensure compliance and to determine the resulting prioritization for action—not for a decision regarding the need to fulfill applicable regulations or legal requirements.
2. Risk can only be effectively managed when it is identified, assessed, considered for further mitigation, and communicated. This principle embodies the four stages of an effective quality risk-management process as defined by ICH Q9: risk assessment (i.e., risk identification, analysis, and evaluation); risk control (i.e., risk reduction and acceptance); risk communication; and risk review.
3. All quality risk evaluations must be based on scientific and process-specific knowledge and ultimately linked primarily to the protection of the patient. Risk assessment is based on the strong understanding of the underlying science, applicable regulations, and related processes involved with the risk under analysis. Collectively, these components should be assessed first and foremost with regard to the potential impact on the patient.
4. Effective risk management requires a sufficient understanding of the business, the potential impact of the risk, and ownership of the results of any risk-management assessment.
5. The risk assessment must take into account the probability of a negative event in combination with the severity of that event. This principle also serves as a useful working definition for risk (i.e., risk represents the combination of the probability and severity of any given event).
6. It is not necessary or appropriate to always use a formal risk-management process (e.g., standardized tools). Rather, the use of an informal risk-management process (e.g., empirical assessment) is acceptable for areas that are less complex and that have a lower potential risk. Risk decisions are made by industry every day. The complexity of the events surrounding each decision and the potential risk involved are important inputs in determining the appropriate risk-assessment methodology and a corresponding level of analysis required. For less complex, less risky decisions, a qualitative analysis (e.g., decision tree) of the options may be all that is required. In general, as the complexity and/or risk increases, so should the sophistication of the risk-assessment tool used. In the same regard, the level of documentation of the risk-management process to render an appropriate.
|The Components of the Quality Risk Management Process (ICH Q9)