Quality parameters (German translation: Qualitätsparameter) are quantitative characteristics that make it possible to evaluate the individual properties of a product, service or process. These parameters can be used to determine whether products, services and processes meet specified quality standards and targets and whether certain areas need improvement. In the pharmaceutical industry, quality parameters play an important role in compliance with GMP standards and other legal requirements.

The most important properties of quality parameters:

• Measurability: Quality parameters must be clearly defined and measurable so that they can be objectively monitored and analyzed. Measurable parameters include, for example, the number of deviations (German: Abweichungen) identified, the percentage of standards met or customer complaint response time.
• Clarity: The delivered results must clearly illustrate the quality of the respective product or process.
• Regularity of evaluation: Quality parameters are continuously evaluated so that changes can be responded to quickly and a stable level of quality can be maintained.
• Information and relevance: The selection of parameters is based on the special features of a product or service and reflects the most important aspects related to quality.

Examples of quality parameters:

• Key production figures: e.g. reject rate, equipment downtime and degree of fulfillment of the production plan.
• Deviations and deficiencies: Number of deviations from standard operating procedures (SOPs) and deficiencies identified during regulatory inspections or self-inspections.
• Customer satisfaction index: Number of complaints, response time for incoming complaints and satisfaction level based on customer surveys.
• Key figures for staff training: Number of employees trained and completion rate of training programs in the field of GMP and quality standards.
• Implementation time and effectiveness of corrective measures: The time required to implement corrective and preventive actions (CAPA; German translation: Korrektur- und Vorbeugemaßnahmen) after deficiencies have been identified.

The importance of quality parameters:

• Monitoring and improvement: Thanks to quality parameters, deviations can be quickly identified and rectified, allowing a high level of quality to be maintained.
• Evaluation of a quality system’s effectiveness: Quality parameters provide information regarding the extent to which the quality system ensures compliance with quality standards.
• Increased transparency: Quality parameters make processes transparent and help management to make well-founded decisions.

Quality parameters are therefore a crucial element of the quality system of a pharmaceutical company, as they ensure the control of important processes and compliance with high pharmaceutical industry standards.

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