The term Qualification allocates certain limits or restrictions to attributes of equipment, utilities or processes related to its performance. The qualification normally includes Design Qualification (DQ), Installation Qualification (IQ) and Operation Qualification (OQ). Finally, the measurement of those attributes in those ranges for those functions is done in the Performance Qualification (PQ).


The action of proving that any equipment or process works correctly and consistently and produces the expected results. Qualification is part of, but not limited to, a validation process, i.e., installation qualification (1Q), operation qualification (OQ), and performance qualification (PQ).

Qualification Protocol

A Qualification Protocol (QP) is a written plan or procedure stating in sufficient detail how qualification will be achieved. Included are specific qualification requirements for each equipment item, each system requirement, and product requirement. Each protocol should stipulate test parameters as well as decision points on what constitutes acceptable test results. The written protocols should be based on the associated qualification procedures and should be step-by-step instructions to be used in the field to qualify equipment, instruments, materials, systems and subsystems, and should include data sheets to record critical data. 


The term qualified is used in the content of verification of being capable of providing the required performance, used in reference to personnel, utilities, and equipment.

Qualified Person EC Directive 75-319

The qualified person (QP) is the person(s) among key Manufacturing and Quality personnel responsible for GMP compliance and the release of every Batch of final Products.


A person who meets educational and experience requirements detailed in EU Directive 2001/83/EC. All holders of Manufacturer's Authorisations in the EU must have at least one QP permanently and continuously available. QP release is required for each batch of product sold or used in a clinical trial in the EU.

Qualified Supplier

A qualified supplier is often defined as an approved supplier which did undergo a program of comparative testing that has demonstrated the ability to consistently supply a material of an acceptable quality level and has demonstrated the reliability of their test results.


The term Quality is used in the GMP environment as the totality of features and characteristics of a product or service that bears on its ability to satisfy stated or implied needs including the conformance to requirements to specifications.

Quality Assurance

The Quality Assurance ensures that Product Quality, safety, purity and efficacy is known and effectively controlled.


The sum total of the organized activities performed with the intent to ensure that all APIs are of the quality required for their intended use.

Quality Assurance Unit

The Quality Assurance Unit sets policies, procedures and specifications, audits, reviews, assesses and training including continuous evaluation of the adequacy and effectiveness of the overall quality program, including corrective and preventive measures (CAPA) which are initiated where necessary.

Quality Audit

Is a systematic, independent examination of a manufacturer´s quality system that is performed at whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.

Quality Control

The term Quality Control is used as part of GMP, which is concerned with assessing and measuring specific quality attributes.

Quality Control Unit

The Quality Control Unit is the function in the Quality Unit that is responsible for the ongoing control of product and environment quality. Therefore the Quality Control Unit (QC) has the overall responsibility for acceptance or rejection of e.g.:

  • Raw materials
  • Drug Substance /API
  • Packaging components
  • In-Process Controls (IPC)
  • Labelling and Inspection
  • Assurance that supporting systems are being controlled and monitored
  • Drug Product / finished dosage forms.
  • Medical Devices
  • etc.



Any person or organizational element designated by the firm to be responsible for the duties relating to quality control.

Quality policy

The overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.

Quality Records

A Quality Records in the GMP environment is any official written and retained raw data records that cover any part of the overall Production and Storage process of a Product. 

Quality System

Organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. 

Quality Unit

The term Quality Unit is often used for all encompassing roles and responsibilities of the Quality Assurance and Quality Control units. Should be independent from Production.


The term quarantine is used to describe a special status of Materials, Intermediates or Products that are isolated or otherwise withheld from use, pending a decision on their release, rejection, or reprocessing.


The status of materials isolated physically or by other effective means pending a decision on their subsequent use.