Action limit:Established criteria, requiring immediate follow-up and corrective action if exceeded.
Air lock:
An enclosed space with two or more doors, and which is interposed between two or more rooms, e.g. of differing class of cleanliness, for the purpose of controlling the air-flow between those rooms when they need to be entered. An air-lock is designed for and used by either people or goods.
Alert limit:
Established criteria giving early warning of potential drift from normal conditions which are not necessarily grounds for definitive corrective action but which require follow-up investigation.
Qualified person:
Person recognized by the authority as having the necessary basic scientific and technical background and experience.
Batch (or lot):
A defined quantity of starting material, packaging material or product processed in one process or series of processes so that it could be expected to be homogeneous.
Note: To complete certain stages of manufacture, it may be necessary to divide a batch into a number of sub batches, which are later brought together to form a final homogeneous batch. In the case of continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity.
For the control of the finished product, a batch of a NHPs comprises all the units of a pharmaceutical form which are made from the same initial mass of material and have undergone a single series of manufacturing operations or a single sterilisation operation or, in the case of a continuous production process, all the units manufactured in a given period of time.
Batch number (or lot number):
A distinctive combination of numbers and/or letters which specifically identifies a batch.
Biological agents:
Microorganisms, including genetically engineered microorganisms, cell cultures and endoparasites, whether pathogenic or not.
Bulk product:
Any product which has completed all processing stages up to, but not including, final packaging.
Calibration:
The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard.
Clean area:
An 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.
Clean/contained area:
An area constructed and operated in such a manner that will achieve the aims of both a clean area and a contained area at the same time.
Containment:
The action of confining a biological agent or other entity within a defined space.
Primary containment:
A system of containment which prevents the escape of a biological agent into the immediate working environment. It involves the use of closed containers or safety biological cabinets along with secure operating procedures.
Secondary containment:
A system of containment which prevents the escape 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 airlocks and/or sterilizes for the exit of materials and secure operating procedures. In many cases it may add to the effectiveness of primary containment.
Contained area:
An area constructed and operated in such a manner (and equipped with appropriate air handling and filtration) so as to prevent contamination of the external environment by biological agents from within the area.
Controlled area:
An area constructed and operated in such a manner that some attempt is made to control the introduction of potential contamination (an air supply approximating to grade D may be appropriate), and the consequences of accidental release of living organisms. The level of control exercised should reflect the nature of the organism employed in the process. At a minimum, the area should be maintained at a pressure negative to the immediate external environment and allow for the efficient removal of small quantities of airborne contaminants.
Computerized system:
A system including the input of data, electronic processing and the output of information to be used either for reporting or automatic control.
Cross contamination:
Contamination of a starting material or of a product with another material or product.
Finished product:
A NHPs which has undergone all stages of production, including packaging in its final container.
In-process control:
Checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms to its specification. The control of the environment or equipment may also be regarded as a part of in- process control.
Intermediate product:
Partly processed material which must undergo further manufacturing steps before it becomes a bulk product.
Manufacture:
All operations of purchase of materials and products, Production, Quality Control, release, storage, distribution of NHPs and the related controls.
Manufacturer:
Holder of a manufacturing authorization.
Packaging:
All operations, including filling and labelling, which a bulk product has to undergo in order to become a finished product.
Note: Sterile filling would not normally be regarded as part of packaging, the bulk product being the filled, but not finally packaged, primary containers.
Packaging material:
Any material employed in the packaging of a NHPs, excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.
Procedures:
Description of the operations to be carried out, the precautions to be taken and measures to be applied directly or indirectly related to the manufacture of a NHPs.
Production:
All operations involved in the preparation of a NHPs, from receipt of materials, through processing and packaging, to its completion as a finished product.
Qualification:
Action of proving that any equipment works correctly and actually leads to the expected results. The word validation is sometimes widened to incorporate the concept of qualification.
Quality control:
See Chapter 1.
Quarantine:
The status of starting or packaging materials, intermediate, bulk or finished products isolated physically or by other effective means whilst awaiting a decision on their release or refusal.
Record:
See Chapter 4.
Recovery:
The introduction of all or part of previous batches of the required quality into another batch at a defined stage of manufacture.
Return:
Sending back to the manufacturer or distributor of a NHPs which may or may not present a quality defect.
Starting material:
Any substance used in the production of a NHPs, but excluding packaging materials.
Health Product:
Finished labeled products in pharmaceutical dosage forms, which are usually low risk ingredients that are intended to restore, correct, modify physiological functions by exerting pharmacological, immunological or metabolic actions