Manufacturing (LAS 1-5)

LAS 1-5

Drug Manufacturing

Drug Manufacturing

is a process of industrial scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry

Actual Yield

the quality that is actually produced at any phase of production

Active Ingredient

any component which is intended to furnish pharmacological activity on the diagnosis, cure, mitigation of disease

Batch

a quantity of drug that is homogeneous in character and quality that is produced during a given cycle of manufacturing

Batch number

a combination of number or letter that identifies the batch

Bulk product

any processed material which has to undergo another process to become a finished product

Component

any material to be used for the manufacture of a product, raw or packaging materials

Cosmetics

any articles intended to be sprinkled, rubbed, poured, and applied to the human body

Date of manufacture

the date indicating the start of processing for every batch

Dispensing

the act of measuring, weighing, and counting of starting

Quality

the degree to which a set of inherent properties of a product fulfills requirements

Pharmaceutical Quality System

Management system to direct and control a pharmaceutical company about quality

Quality system

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

Quality Risk Management

A systematic process for the assessment, control, communication and review of risks

Change Management

A systematic approach to proposing, evaluating, approving, implementing, and reviewing changes

Product Realisation

Achievement of a product with the quality attributes that meet the needs of patients

Risk

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

Risk Communication

The sharing of information about risk and risk management

Risk Control

Actions implementing risk management decisions

Risk Evaluation

The comparison of the estimated risk to the given risk

Risk Management

The systematic application of quality management policies

Risk Reduction

Actions taken to lessen the probability of occurrence of harm

Risk Review

Review or monitoring of output/results of risk management process

ICH Q10

An internationally harmonized guidance intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system

Correction

any action taken to eliminate non-conformity

Corrective Action

any action to eliminate the cause of a detected non-conformity

Preventive Action

any action to eliminate the cause of potential non-conformity

Contamination

the undesired introduction of impurities

Contaminant

any particulate that can adversely affect the product or the process

Good Documentation Practice (GDP)

A systematic procedure of preparation, reviewing, approving, issuing, recording, storing, and archival of any document

Good Laboratory Practices

the organizational process and conditions under which laboratory studies are planned, performed, monitored, recorded, and reported3