Quality Roles
Sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe, effective, and acceptable to the patient.
What is Quality Assurance ?
The controlled set of actions necessary to ensure a change does not negatively impact a product’s safety, efficacy, quality or compliance.
What is a Change Control?
All the practices that ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation.
What is GMP?
Is a drug without the active ingredient that normally is used during clinical trials
What is a placebo?
Is a set of step-by-step instructions put together by an expert, a team or an organization to help workers carry out routine operations.
What is a Standard Operating Procedures (SOPs)?
Aims to verify and test the medicine at various stages of production to ensure every product is of the highest quality.
What is Quality Control?
Any unwanted event that differs from the approved processes, procedures, instructions, specifications, or established standards.
What is a Deviation ?
The entire process is designed to reduce the particle shedding count from personnel. Special clothing is required. It can consist of aprons, sleeves, gloves, hoods, shoe covers, coveralls, head coverings, lab coats, smocks, shirts/pants, hats/caps, facemasks, and beard covers.
What is garbing?
Is the accuracy, validity, and consistency of data over its entire life-cycle and is a critical aspect of the design, implementation, and usage of any system that stores, processes, or retrieves data.
What is Data Integrity?
Validation activities that prove the equipment used to manufacture the medicine is clean and cannot contaminate the medicine that is made in it. It prove that the documented cleaning procedure will consistently remove the previous product, cleaning agent, and reduce the microbial population to a safe and acceptable level.
What is cleaning validation?
The person responsible for the final release of a batch of pharmaceutical product, finished products that are ready for consumption only.
What is a QP?
Stands for Corrective and Preventive Action, is a quality management system approach used to identify, investigate, and address deviations, discrepancies, or non-conformances in processes, products, or systems.
What is a CAPA?
Evaluations conducted by government agencies to ensure compliance with legal, safety, and quality standards.
What is an inspection?
A highly characterized material suitable to test the identity, strength, quality and purity of substances for pharmaceutical use and medicinal products.
What is a reference standard?
A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.
What is a Batch?
Manage the lifecycle of specifications, policies, and other important documents through version control and a centralized repository.
What is Quality systems ?
It is a regulatory requirement under which pharmaceutical companies are expected to conduct yearly product quality reviews of their commercialized products.
What is APQR?
Contamination of a material or of a product with another material or product.
What is a cross contamination?
Is a software that allows you to effectively manage samples and associated data. By using it, your lab can automate workflows, integrate instruments, and manage samples and associated information
What is LIMS?
Digital solution that tracks and documents the batch manufacturing process. It replaces paper-based, slow and error-prone processes in the manufacture of pharmaceutical and biopharmaceutical products.
What is Manufacturing Execution System (MES)?
Focuses on audits and inspections to detect whether a drug meets the minimum requirements of laws, regulations, and industry guidelines – set by regulatory agencies.
What is Quality Compliance?
A systematic process for the assessment, control, communication and review of risks to the quality of pharmaceutical products across the product life-cycle.
What is Quality risk management (QRM)?
Action of proving, in accordance with the principles of Good Manufacturing Practice, that any procedure, process, equipment, material, activity or system actually leads to the expected results
What is Validation?
Confirms that the equipment and systems meet the users’ needs and is fit for intended use as defined in the user requirements specification (URS). It is the final step in equipment qualification.
What is a Performance Qualification (PQ)?
Process used to test, validate and formally document that a regulated computer-based system does exactly what it is supposed to do as per its design requirements in a consistent and accurate manner that is safe, secure and reliable
What is Computer systems validation (CSV)?