Pharmaceutical Quality System Module 2

Vocabulary terms and definitions related to Quality Risk Management, Contamination, Cross-Contamination, Good Documentation Practice, Good Laboratory Practice, and Self-Inspection from Module 2 of the Pharmaceutical Quality System course.

Quality Risk Management

A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle.

Decision Maker(s)

Person(s) with the competence and authority to make appropriate and timely quality risk management decisions.

Detectability

The ability to discover or determine the existence, presence, or fact of a hazard.

Harm

Damage to health, including the damage that can occur from loss of product quality or availability.

Hazard

The potential source of harm.

Product Lifecycle

All phases in the life of the product from the initial development through marketing until the product’s discontinuation.

Quality

The degree to which a set of inherent properties of a product, system or process fulfills requirements.

Quality System

The sum of all aspects of a system that implements quality policy.

Requirements

The explicit or implicit needs or expectations of the patients.

Risk

The combination of the probability of occurrence of harm and the severity of that harm.

Risk Acceptance

The decision to accept risk.

Risk Analysis

The estimation of the risk associated with the identified hazards.

Risk Assessment

A systematic process of organizing information to support a risk decision to be made within a risk management process.

Risk Communication

The sharing of information about risk and risk management between the decision maker and other stakeholders.

Risk Control

Actions implementing risk management decisions (ISO Guide 73).

Risk Evaluation

The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk.

Risk Identification

The systematic use of information to identify potential sources of harm.

Risk Management

The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating and reviewing risk.

Risk Reduction

Actions taken to lessen the probability of occurrence of harm and the severity of that harm.

Risk Review

Review or monitoring of output/results of the risk management process considering (if appropriate) new knowledge and experience about the risk.

Severity

A measure of the possible consequences of a hazard.

Stakeholder

Any individual, group or organization that can affect, be affected by, or perceive itself to be affected by a risk.

Trend

A statistical term referring to the direction or rate of change of a variable(s).

PDCA Cycle

A powerful tool used in manufacturing to help organizations achieve continuous improvement, standing for Plan, Do, Check, Act.

High Risk

Indicates a severe, unacceptable threat to patient health, where immediate corrective and preventive actions are mandatory.

Medium Risk

Threatens process stability or product quality but does not pose an immediate danger; requires mitigation and documented reduction strategies.

Low Risk

Minor or remote deviations that are often acceptable with standard operating procedures without extensive additional measures.

RPN

The Risk Priority Number, established by the formula $RPN = S \times O \times D$, where S is Severity, O is Occurrence, and D is Detectability.

Failure Mode Effects Analysis (FMEA)

Provides for an evaluation of potential failure modes for processes and their likely effect on outcomes and/or product performance.

Failure Mode, Effects and Criticality Analysis (FMECA)

Identifies places where additional preventive actions might be appropriate to minimize risks.

Fault Tree Analysis (FTA)

A tool that evaluates system or sub-system failures one at a time, combining multiple causes by identifying causal chains.

Hazard Analysis and Critical Control Points (HACCP)

A systematic, proactive, and preventive tool for assuring product quality, reliability, and safety.

Hazard Operability Analysis (HAZOP)

A theory assuming that risk events are caused by deviations from the design or operating intentions.

Preliminary Hazard Analysis (PHA)

An analysis tool based on applying prior experience or knowledge of a hazard or failure to identify future hazards that might cause harm.

Pharmaceutical Contamination

The unintended presence of foreign substances in a drug product that may adversely affect its quality, safety, and therapeutic effectiveness.

Physical Contamination

Occurs when unwanted foreign objects or particles such as glass fragments, metal particles, dust, or fibers are present.

Chemical Contamination

The accidental introduction of chemicals like residual solvents, cleaning agents, or lubricants.

Microbial Contamination

Occurs when microorganisms such as bacteria, fungi, viruses, or their by-products are present in a product.

Endotoxin/Pyrogen Contamination

The presence of substances, such as lipopolysaccharide (LPS) from Gram-negative bacteria, that can cause fever and harmful immune reactions.

Cross-contamination

The unintended transfer of traces of one product, material, or substance to another during the manufacturing process.

Good Documentation Practice (GDP)

A systematic procedure of preparing, reviewing, approving, issuing, recording, storing and archiving of documents.

Raw Data

Any worksheets, records, memoranda and notes of original and first-hand observations and activities of a study necessary for reconstruction and evaluation.

ALCOA

A technique to ensure data compliance standing for Attributable, Legible, Contemporaneous, Original, and Accurate.

Attributable

Requirement that all data must be traceable to the person generating it, including who performed the action and when.

Legible

Requirement that all paper and electronic data must be readable and permanent.

Contemporaneous

The practice of recording paper or electronic data at the time it is performed.

Original

The paper or electronic medium in which the data point is initially recorded, such as protocols, notebooks, or software.

Accurate

Requirement that data should be free from errors, complete, truthful, and reflective of the observation.

Batch Processing Records

A part of the Batch Manufacturing Record kept for each batch to avoid transcription errors and provide evidence of processing actions.

Good Laboratory Practice (GLP)

A quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are conducted.

Self-Inspection

Conducted to monitor the implementation and compliance with Good Manufacturing Practice (GMP) principles and propose corrective measures.