Acceptance criteria:

 Acceptance criteria:

Numerical limits, ranges or other suitable measures for acceptance of test results.

Acceptance quality limit (AQL):

The quality level that is the worst tolerable process average when a continuing series of lots is submitted for acceptance sampling.

Accuracy:

The degree of agreement of test results with the true value or the closeness of the results obtained by the procedure to the true value.

Action limit:

The action limit is reached when the acceptance criteria of a critical parameter have been exceeded. Results outside these limits will require specified action and investigation.

Air-handling unit (AHU):

The air-handling unit serves to condition the air and provide the required air movement within a facility.

ALCOA:

A commonly used acronym for “attributable, legible, contemporaneous, original and accurate”.

ALCOA+:

A commonly used acronym for “attributable, legible, contemporaneous, original and accurate” that puts additional emphasis on the attributes of being complete, consistent, enduring and available 

– implicit basic ALCOA principles.

Audit:

A systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.

Audit trail:

The audit trail is a form of metadata containing information associated with actions that relate to the creation, modification or deletion of GxP records. An audit trail provides for a secure recording of life cycle details such as creation, additions, deletions or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record.

Batch:

A defined quantity of starting material, packaging material or product, processed in a single process or series of processes, so that it is expected to be homogeneous.

Certificate of analysis (COA):

A document listing the results of testing a representative sample drawn from the batch to be delivered.

Change control:

The processes and procedures to manage system changes.

Clean room:

A room or area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation and retention of contaminants within the area.

Cleaning validation:

Documented evidence to establish that cleaning procedures are removing residues to predetermined levels of acceptability, taking into consideration factors such as batch size, dosing, toxicology, and equipment size.