PHA6124 cGMP Definition of Terms

Calibration

The operations carried out to determine the accuracy of measuring instruments, of "material measures" such as masses or gauges and of measurement standards.

Accuracy

The nearest value obtained during measurement or analysis to the true value.

Precision (in analytical assay and method)

The degree of variation between individual test results when the method is used separately to different samples drawn from the same batch of material.

Precision (in analytical assay and method)

This will include variation between analysts, between days, between tests on the same prepared extract of a given sample, between different extracts and between laboratories conducting the same test.

Precision (in analytical assay and method)

It is normally divided into two types:
- Repeatability (within laboratory), and
- Reproducibility (between laboratories).

Actual Yield

The quantity that is actually produced at any phase of production of a particular drug product based on the initial input.

Theoretical Yield

The quantity that is expected or planned to be obtained at any phase of production of a particular product, based on the quantity of components to be used.

Reconciliation

A resolution between the theoretical and actual yield.

Drug Product

Any substance or mixture of substances in finished dosage forms that is manufactured, offered for sale, or presented for use in (1) the treatment, mitigation, cure, prevention, or diagnosis of disease, abnormal physical state, or the symptoms thereof in man or animal; or (2) the restoration, correction or modification of organic functions in man or animal; regardless of whether it is in package form.

Device

Instrument, apparatus, or contrivances, including their components, parts and accessories, intended (1) for use in the diagnosis, cure, mitigation, or prevention of disease in man and animals; or (2) to affect the structure or any function of the body of man or animal.

Good Manufacturing Practice (GMP)

It is the system of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate for their intended use. It is thus concerned with both manufacturing and quality control processes and procedures.

Manufacture or Manufacturing

The complete set of activities to produce a drug that comprise production and quality control from dispensing of materials to the release for distribution of the finished product.

Quality Control

All control measures taken designed to ensure that finished products consistently conform to established specification of identity, strength, purity and quality.

Procedures

Description of the operations to be executed, the precautions to be implemented directly or indirectly related to the manufacture of a drug.

Documentation

Written recording of all procedures, instructions and processes involved in the manufacture of drug products.

Production

All operations starting from dispensing of materials to processing, packaging, to finished product.

Recovery

The incorporation of all or part of previous batches with the required quality into another batch at a defined step of production.

Dispensing

The activity of weighing, counting or measuring and checking of starting materials and issuing these to the appropriate production personnel; details of the activity being duly and properly documented.

Processing

The part of production cycle starting from weighing of raw materials to finished product.

In-Process Control

Checks and tests instituted and carried out in the course of the manufacture of a drug to assure identity, strength, quality and purity.

Reprocessing

The reworking of all or part of a batch of product of an unacceptable quality from a defined step of production in order that its quality may be rendered acceptable by one or more additional operations.

Packaging

The process of packing which is that part of the production cycle applied to a bulk product to obtain the finished product.

Batch

A quantity of drug product/device that is homogenous in character and quality produced during a given cycle of manufacture and from a specific manufacturing order.

Batch Number

A designation in numbers or letters or combination thereof that identifies the batch, and permits the tracing of the complete history of a batch, including all stages of its production, control and distribution.

Lot

A batch or any portion of batch produced by a continuos process, an amount of drugs produced in a unit of time or quantity in a manner that assures its uniformity and in either case which is identified by a distinctive lot number and has uniform character and quality within specified limits.

Lot Number

See batch number

Representative Sample

A sample representing the lot, the batch, or the total amount of materials based on a sampling plan.

Date of Manufacture

The date indicating the start of processing of every batch.

Expiration Date

A date fixed for each individual batch on or before which the batch is expected to meet the standard specifications for quality, safety and efficacy.

Approved Supplier

A supplier of all components of finished products generally approved for use by the trade and accredited by the manufacturer based on a vendor rating which include but not limited to conformance to the company or compendium material specifications.

Component

Any material intended to be used for the manufacture of a product whether raw or packaging materials.

Raw Material

All substances whether active or excipients that are employed in the processing of a finished product.

Starting Materials

Raw materials used in the production of a finished product (drugs).

Packaging Material

Any material used in the packaging of a bulk product to obtain the finished product.

Bulk Product

Any processed material which has to undergo another process including packaging operation to become a finished product.

Intermediate Product

Any processed substance or mixture of substances which has to undergo one or more further stages of processing to become finished product.

Specification of Material

A description of starting material, intermediate, bulk or finished product in terms of its chemical, physical and microbiological characteristics, if any. It shall include descriptive and or numerical clauses stating standards and tolerated deviations, whenever applicable.

Finished Product

A product which has undergone all stages of manufacturing operations.

Returned Product

Any finished product which is already in distribution and sent back to the manufacturer or distributor due to complaint, damage, expiration, validity or other reasons such as the condition of the container or package which may cast doubt on the product identity, quality, strength and safety.

Cryogenic Vessel

A container designed to store liquefied gas at extremely low temperature.

Cylinder

A container designed to store gas at a high pressure.

Liquefied Gases

Gases that, at the specified temperature and pressure, remain as a liquid in the cylinder.

Manifold

Equipment or apparatus designed to enable one or more gas containers to be filled simultaneously from the same source.

Blood

Whole blood collected from a single donor and processed either for transfusion or further manufacturing.

Unit (of Blood)

The volume of blood or one of its components in a suitable volume of anticoagulant obtained from a single collection of blood.

Processing of Blood

Any process employed after collection and before compatibility testing of blood. It includes the identification of a unit of donor blood, the preparation of components from such unit of donor blood, serological testing, labeling and associated record keeping.

Compatibility Testing

The in-vitro serological tests performed on donor and recipient blood samples to establish the serological matching of a donor's blood or blood components with that of a potential recipient.

Plasma (for further manufacture)

The liquid portion of blood separated and used as material to prepare another product.

Plasmapheresis

The process in which blood is extracted from the donor, the plasma is separated from the formed elements and at least the red blood cells are returned to the donor.

Leukopheresis

The process in which blood is extracted from the donor, a leukocyte concentrate is separated, and the remaining formed elements and residual plasma are returned to the donor.

Plateletpheresis

The process in which blood is extracted from the donor, the platelet concentrate is separated, and the remaining formed elements and residual plasma are returned to the donor.

Cell Culture

The in-vitro growing of cells isolated from multicellular organisms.

Cell Bank System

A system whereby successive batches of a product manufactured by culture in cells derived from the same master cell bank (see Master Cell Bank). Is validated for a passage level or number of population doubling beyond that which was achieved during routine production.

Master Cell Bank

A culture of fully characterized cells filled into containers in a single operation, processed together and stored to ensure uniformity and stability. Is normally stored at -70°C or lower.

Working Cell Bank

A culture of cell derived from the master cell bank and intended for use in the preparation of production of cell cultures and normally stored at - 70°C or lower.

Seed Lot System

Is a system where successive batches of product are derived from the same master seed lot at a given passage level.

Master Seed Lot

A culture of a microorganism distributed from a single bulk into containers in a single operation to ensure uniformity, stability and to prevent contamination.

Working Seed Lot

A culture of microorganism derived from the master seed lot and intended for use in production.

Airlock

An enclosed space with two or more doors, which is interposed between two or more rooms e.g. of different standard of cleanliness for the purpose of controlling the air flow between those rooms when they need to be entered. It may be designed for and used by either people or materials; in the latter case it can be termed a "pass through hatch". An airlock can also be the "anteroom" to a clean room in which sterile goods are handled.

Clean Area

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

Contained Area

An area constructed, operated and equipped with air-handling and filtration system in order to prevent contamination of the external environment by biological agents from within the area.

Controlled Area

An area constructed and operated to control the introduction of potential contamination (an air supply approximately class III may be appropriate), and the consequences of accidental release of living organisms. The level of control exercise shall reflect the nature of the organism employed in the process. The area shall be maintained at a pressure negative to the immediate external environment and allow for the efficient removal of small quantities of airborne contaminants.

Sterile Room or Sterile Area

A room or area of defined environmental condition with controlled particulate and microbial contamination, constructed, equipped and used to eliminate the introduction, generation or retention of contaminants.

Facilities (for Blood Products)

Any area used for the collection, processing, compatibility testing, storage or distribution of blood and blood components.

Facilities (for Other Products; e.g. drugs, medical devices, bulk chemical material and others)

This refers to the building, premises and equipment necessary in the manufacture of drugs.

Contaminants

Anything that cause contamination to the product.

Cross Contamination

Contaminations of a starting, intermediate product or finished product.

Infected (Man or Animal)

Contaminated with extraneous biological agents and therefore capable of spreading infection.

Biogenerator

A contained system, such as a fermenter, into which biological agents are introduced together with other materials in order to effect their multiplication or their production of other substances by reaction with other materials. They are generally equipped with devices for regulation, control connection, material addition and material withdrawal.

Microbiological Agents

Include genetically engineered microorganisms, cell cultures, as well as endoparasites, whether pathogenic or not.

Sanitation

All measures taken to assure suitable or adequate environmental conditions in compliance to GMP.

Sterilization

Inactivation or reduction to an acceptable level of all viable microorganisms by a suitable process.

Quarantine

An act of holding off a material for use, or a product for packaging or distribution by physically setting it apart or by system duly validated, pending a decision on release or rejection.

Primary Containment

A system of containment that prevents the dispersal of a biological agent into the immediate working environment. It involves the employment of closed containers or safety biological cabinets accompanied with secure operating procedures.

Secondary Containment

A system of containment that prevents the dispersal of a biological agent into the external environment or into other working areas. It involves the use of rooms with specially designed air handling, the existence of air locks and/or sterilizers for the exit of material. It may add to the effectiveness of primary containment.

Rejected

The status of materials or products which are not permitted to be used for processing, packaging or distribution.

Released or Passed

The status of materials or products which are permitted to be used for processing, packaging or distribution.

Validation

The process of confirming by recognized appropriate means or manner, that any material, process, procedure, activity, system, equipment or mechanics used in production and control consistently achieved the desired results.

Worst Case

A condition or set of conditions encompassing upper and lower processing limits and circumstances, within standard operating procedures, which pose the greatest chance of product or process failure when, compared to ideal conditions. Such conditions do not necessarily induce product or process failure.