GMP Glossary & Definitions
Packaging Integrity:
The packaging integrity is the assurance that the designed packaging component fulfils the predefined requirements in protecting the product during transportation, storage and handling during the products full self life.
Packaging:
Packaging is called the process of assembling the Final Product. This act may include but is not limited to filling, capping, labelling, cartoning and packing.
Packaging Components:
The term packaging components or packaging material is used for delivery devices, primary packaging Components, secondary packaging components or any other packaging components.
Packing Material:
The term Packing Material is used for the non-product contact materials used to hold, protect and ship the primary container.
Passivation:
A process in which a diluted nitric acid solution is used to remove discoloration from weld areas as well as dissolve and flush out all iron particulates and residue. These deposits may be the result of being improperly cleaned and stored at the mill, the fab shop or the site. In the case of piping systems the process involves circulating the heated nitric acid solution for a period of time followed by a thorough flushing with potable or purified water. A test is then done to determine if free iron can be detected. When the test determines that the system is clear of any contaminants potable or purified water is flushed through the system until the pH and conductivity/resistivity of the effluent water samples are the same as that of the influent.
Percentage of theoretical yield:
The ratio of the actual yield (at any appropriate phase of the manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage.
Performance Qualification (PQ):
The performance qualification is the documented evidence that an operation consistently operates in its predefined acceptance criteria.
or
Performance Qualification (PQ) provides documented evidence that the integrated system or process is capable of consistently producing the intended product in a high quality and safe manner.
Personal Training File:
The personal training file contains the relevant employee’s documentation on the qualifications, experience, and training/assessment of an individual.
Personal Training Plan:
The personal training plan is an employee specific plan addressing an individual’s GMP and technical training needs.
Pest Control Program:
The Pest Control Program is a documented program which should be applied at any warehouse, storage or manufacturing facilities to monitor the presence of rodents, pests, birds and insects with the goal to eliminate the vermin.
Pharmaceutical:
Referring to pharmacy or medical drugs; any therapeutic product used in medicine. A pharmaceutical is a drug derived from organic or inorganic chemicals and used to treat a wide range of medical conditions.
Pharmaceutical Waste:
Pharmaceutical Waste is the waste which is generated during the manufacture of Drug Substance / Active Pharmaceutical Ingredient or a Pharmaceutical Product.
Pharmaceutical Research and Manufacturers of America (PhRMA):
Formerly known as PMA, this is a nonprofit scientific and professional organization of more than 100 firms that discover, develop and produce prescription drugs and biological products in the United States. The Association’s members produce most of the prescription drugs used in the United States and about half of the free world’s supply of prescription drugs.
Pharmacodynamics:
The study of drug action primarily in terms of drug structure, site of action, and the biochemical and physiological consequences of the action. pharmacoeconomics: Studies focusing on the total impact of the product or services on the health system. Pharmacoeconomics relies upon several economic methodologies, including cost-benefit, cost-effectiveness and cost-utility analysis.
Pharmacokinetics:
The study of how the body handles a drug, with particular emphasis on the time required for absorption, duration of action, distribution through the body and method of excretion. pharmacology: The science that deals with the study of drugs in all aspects, including drugs’ mechanisms of action.
Phase I clinical trials:
Small studies involving healthy volunteers to assess drug tolerability (safety), metabolism, structure-activity relationships, and mechanism of action in humans.
Phase II clinical trials:
Tests designed to determine, under controlled conditions, whether or not a drug has therapeutic benefit (efficacy) with individuals having the target disease (patients) and document eventual short-term side effects (adverse reactions) and risks associated with the drug.
Phase III clinical trials:
Larger studies to gain confirmatory efficacy and safety data in a broad base of patients. The compound is given to patients according to a protocol that reflects the way the compound is expected to used when it is on the market. These expanded studies generally include hundreds of site locations and involve thousands of patients.
Phase IIIb clinical trials:
Trials that come after the new drug application is filed, but before the product is approved for marketing. The goal of these studies is to provide additional data for marketing support and the ultimate product launch, including conducting country-specific studies to support local needs.
Phase IV human testing or post-marketing surveillance:
Tests conducted after marketing to obtain additional data regarding product safety and efficacy over the life of a drug. The pharmaceutical is on the market and generating revenue during this period.
Physical manipulation:
A process other than a chemical reaction that may change the purity or the physical properties of the material, including but not limited to crystallization, recrystallization, gel filtration, chromatography, milling, drying, or blending.
Pilot scale:
The manufacture of an API on a reduced scale by processes representative of and simulating those to be applied on a larger commercial manufacturing scale.
Placebo:
Inactive agent without therapeutic value used in controlled studies to determine the efficacy of the potential therapeutic agent against which it is being compared. The placebo is made to look exactly like the therapeutic agent.
PIC:
Pharmaceutical Inspection Convention
Placebo:
The Placebo is an inactive clinical supply containing all excipients but no Drug Substance / Active Pharmaceutical Ingredient.
Polishing ( sanitary stainless steel piping):
The process of resolving the roughness of the outside and/or the inside wall of stainless steel pipe by one of two methods:
- grit polishing – a manual method of using an abrasive pad (sandpaper) with varying, specified degrees of fineness to achieve a specified degree of smoothness.
- electropolish – an electrochemical method of removing metal from a surface.
Polymorphism:
The occurrence of different crystalline forms of the same API.
Potential impurity:
An impurity that, from theoretical considerations, may arise from or during manufacture. It may or may not actually appear in the API.
Preclinical Research:
Group of studies that test a drug on animals and other nonhuman test systems. This testing is conducted to gain more data about the pharmaceutical’s efficacy and safety before tests on humans can begin.
Pre-Approval Inspection (PAI):
A Pre-Approval Inspection is an inspection performed by a government regulatory agency such as the FDA in response to an NDA (New Drug Application) or equivalent submission whose objective is to assess the applicant’s attributes against the GMPs and filed documents before final approval of the submitted dossier.
Preventative Action:
The preventive action is the action taken to address the root cause of the deviation and prevent reoccurrence of the event.
Preventive Maintenance:
The Preventive Maintenance describes all scheduled work done on a routine, predefined basis to maintain facilities, equipment, utilities and devices in good status in order reliably performance.
Primary (primacy) Reference Standards:
A primary reference standard is an official substance whose characteristics and potency are warranted by a certified body.
or
A particular portion, lot or batch of an API or intermediate that has been shown by an extensive set of analytical tests to be of the highest purity. This standard may be purchased from a recognized source or may be prepared by independent synthesis or by further purification of existing production material.
Primary Container:
The primary container is the container containing the product.
Printed packaging components:
Printed packaging components are e.g. labels, leaflets, inserts, cartons, etc.
Procedure:
A procedure is a clear and precise documented description of an activity including the methods to be employed and responsibilities. This might be in may cases a Standard Operating Procedure (SOP).
Process Control
The process control are the installed controls helping to manage a process and limiting process variations by observation, analysis, interpretation and action.
Process Validation:
The process validation is the documented evidence that a process will consistently produce a product meeting its predefined acceptance criteria and quality attributes with a high degree of assurance.
or
Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics.
Process Performance Qualification:
Establishing confidence that the process is effective and reproducible.
Product Performance Qualification:
Establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety.
Prophylactic Treatment:
Preventative treatment or precautions to avoid disease; treatment intended to preserve health and prevent the spread of disease.
Proprietary Medicines:
Over the counter (nonprescription) medicines sold under a trademark and advertised to the general public.
Production Scale:
The production scale is the scale of a proposed commercial process for the commercial production of Drug Substance / Active Pharmaceutical Ingredient or Drug Product.
Prospective Validation:
A prospective validation is a validation, which must be completed before a process is used, or before a Product is released to the market.
or
Establishing documented evidence that a system does what it purports to do prior to the commercial distribution of a new API or an existing API made by a new or modified process.
Protocol:
A protocol is a reviewed and approved document that clearly indicates the objectives, experimental steps, test parameters and the acceptance criteria to perform a study in a GMP environment.
or
Written documentation establishing strict and detailed guidelines and requirements for the proper execution of an activity designed to verify the proper installation or operation of a specific component, segment or system of a new or existing facility.
Purification Procedure:
A process, such as crystallization, distillation, or chromatography, intended to improve the purity of an API or intermediate.
