Pharmaceutical Job Related All Definitions
Chapter: Quality Assurance
Validation
Validation is establishing docomented evidence that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting its pre-determined acceptance criteria.
Process validation phase
Process validation phase is designed to verify that all established limits of the critical process parameters are valid and that satisfactory products can be produced even under the worst case conditions.
Process Validation
Process Validation is establishing docomented evidence that provides a high degree of assurance that a specific process will consistently produce a result meeting its pre-determined specifications and quality characteristics.
Process validation phase
Process validation phase designed to verify that all established limits of the critical process parameters are valid and that satisfactory products can be produced even under the worst case condition.
Cleaning validation
Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredirnts of the product manufactured in a piece of equipment.
All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a GMP requirement.
Prospective validation
Prospective validation is carried out during the development stage by means of a risk analysis of the production process.
Concurrent validation
Concurrent validation is carried out during nornal production.
Concurrent validation may be practical approach under certain circumstances.
Retrospective validation
Retrospective validation involves the examination of past experience of production on the assumption that composition, procedures and equipment remain unchanged.
Such experience and the result of in-process and final control tests are then evaluated.
Recorded difficulties and failures in production are analyzed to determine the limits of process parameters.
Revalidation
Revalidation provides the evidence that changes in a process and or the process environment that are introduced do not adversely affect process characteristics and product quality.
Benefits of Validation
⇨ Increase rate of production
⇨ Reduction in rejection and rework
⇨ Reduction in utility vosts
⇨ Fewer complaints about process related failures
⇨ Reduced testing in procesd and finished goods.
⇨ More rapid and accurate investigations into process deviations
⇨ More rapid and reliable startup of new equipment
⇨ Easier scale-up from development work.
⇨ Easier maintenance of the equipment
⇨ More rapid automation
⇨ Improve emploee awareness of processes
Process design
Process design is the activity of defining the commercial manufacturing process.
The goal of this stage is to design a process suitable for routine commercial manufacturing that can consistently deliver a product that meets its critical quality attributes.
Process Qualification
During this stage, the process design is confimed as being capable of reproducible commercial manufacturing.
It confirms that all established limits of the critical parameters are valid and that satisfactory products can be produced even under worst case condition.
Continued Process Verification
Continually assure that the process remains in a state of conttol during commercial manufacturing.
Design Qualification
Design qualification is used at the stage where a design that has been developed from the VMP, cGMP and other Health and Safety guidelines, is reviewed and documented by competent persons to ensure that the design equipment, if built, will satisfy all the detailed specified requirements.
The design qualification js the only document that is going to confirm that the design will work.
Installation Qualification
The performance of tests to ensure that the installations such as machines, measuring devices, utilities and manufacturing areas, used in a manufacturing process are appropriately selected and correctly installed and operate in accordance with established specifications.
Operational Qualification
The documented action of demonstrating that the process equipments and ancillary systems work correctly and operate consistently in accordance with established specifications.
The operational qualification includes a review of the standard operating procedure for start up, operation, maintenance, safety and cleaning.
Performance Qualification
PQ ensures that the system/equipment perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data
Results must demonstrate that performance consistently meets pre-determined specifications under normal conditions and where appropriate for worst case situations.
Quality Assurance
Quality Assurance is a planned and systematic set of activities necessary to provide adequate confidence that a product or service will satisfy given requirements for quality.
Quality Control
Quality control is the operational techniques and activities that are used to fulfill the requirements for quality.
Qualification
Qualification is the planning, carrying out and recording of tests on equipment and systems, which form part of the validated process, to demonstrate that it will perform as intended.
Tyndall effect
The scattering of light by the dispersed phase is called tyndall effect.
Wet granulation
Wet granulation is a process of dry mixing, wet mixing and particle size enlargement and is a process of particle attachment.
Relative Standard Deviation (RSD)
RSD is a measure of precision (not accuracy)
RSD= Standard deviation/ Mean deviation
Incident
Incident is any event that can affect product quality or not but is against the cGMP.
OOS (Out of Specification)
Out of specification means an examination, measurement or test result that does not comply with pre-established criteria. In this case batch is failed to meet the specification. Thus OOS needs correction. [ Comply⇨ মেনে চলা]
OOT (Out of Trend)
A result that does not the expected trend in comparison with other batch or previous result during stability study.
URS (User requirement Specification)
URS is a document usually provides a high level of description of the user's expectation of the project scope.
Product Recall
A product recall is a request to return a marketed product for the reason relating deficiencies in quality, safety or efficacy considered to violation of the laws.
RCA (Root Cause Analysis)
Root cause analysis is a method that is used to address a problem or non-conformance, in order to set to the root cause of the problem.
Dossier
Pharmaceutical dossier is the set of documents which includes multi-disciplinary information regarding the safety and efficacy of the product.
একটি প্রোডাক্টের Safety এবং Efficacy সম্পর্কিত তথ্যাবলির Document হচ্ছে Dossier
CTD
Chapter: Technology
Glidants
Glidants are type of excipent that are added to the formulation to improve flow properties of the materials
Wetting agents
Wetting agents are type of excipent that are added to tablet formulation to aid water uptake during disintegration and assist drug dissolution.
ICH
ICH is the short form of International conference on Harmonization of technical requirements for registration of pharmacruticals for human use. ICH discuss scientific and technical aspects of drug registration. The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines. [ Obviate⇨ পরিহার করা]
MHRA
The Medicines and Healthcare Products Regulatory Agency is a UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
ISO
The International Organization for Standardization is an international standard setting body composed of representatives from various national standards organizations. (ISO9001:2000, ISO9001:2008, ISO9001:2015)
PIC & PIC/S
PIC and PIC/S are two international instruments between countries and Pharmacdutical inspection authorities.
PIC/S is an instrument to improve co-operation in the field of Good Manufacturing Practies between regulatory authorities and the Pharmaceutical industry.
PIC
It is an agreement between the health authorities of the European Union member states. It is convention as well as formal treaty between countries which has legal status. By PIC mutual recognition of inspection between countries are happened.
Document
A document is a written, drawn, presented or recorded representation of thoughts.
Record
Records are historical files that provide proof of existence.
Documantation
Documentation is a set of documents that provides official information or evidence or that serve as a record.
IPC
In Process control is the checks made during the course of manufacture which aims to ensure that product will comply with specifications.
Line Clearance
Line Clearance is the removal of all previous materials, products and related documents from the process line before starting the next new product or new batch of the same product
Beer-Lambert Law
The absorbance of the dilution is directly proportional to the concentration of the absorbing species in the solution and the path length.
Pharmaceutical Instruments
AAS
Atomic absorption spectroscopy is a spectro-analytical procedure for the quantitative determination of chemical elements employing the absorption of optical radiation by free atoms in the gaseous state. AAS can be used to determine over 70 different elements in solution or directly in solid samples.
Conductivity meter
An electrical conductivity meter measures the electrical conductivity in a solution. It is commonly used in hydroponics, aquaculture and freshwater systems to monitor the amount of nutrients, salts or impurities in the water.
Hardness
Hardness is also called crushing strength. It is the load required to crush the tablet when placed on its edge. Official standard for hardness of common tablet is 5-8 kg/cm2 and for sustained release tablets is 8-12 kg/cm2.
Hardness tester
A device to test the hardness of tablet. By this meter the diameter, thickness and hardness are tested. The first reading for diameter, second reading for thickness and the third reading for hardness.
Friability
Friability is the ability of a solid substance to be reduced to smaller pieces with little effort. The main purpose is to evaluate the ability of the tablets to withstand the breakage during the transportatiin and handling.
Friability limit
According to BP, percentage of friability should not be more than 0.8 % and according to USP 1%
Disintegration
Disintegration is the process by which a solid oral dosage form breaks up in water when measured in a standard apparatus. The usual disintegration time for uncoated tablets is 15 minutes, for film coated and hard gelatin capsules is 30 min and for other coated tablets is 60 min.
Dissolution
Dissolution is the process by which a solid drug substance becomes dissolved in a solvent.
Powder
Powder is a mixture of finely divided drugs in a dry form.
Bulk volume
The total volume occupied by the entire powder mass under the particular packing achieved during the measurement is known as bulk volume.
Bulk Density
Bulk density is the mass of many particles of the material devided by the total volume they occupied. (Total volume includes particle volume, inter-particle void volume and internal pore volume)
Tapped density
Bulk density after consolidation is termed as Tapped density.
True volume
The total volume of the solid particles, which excludes all spaces greater than molecular dimensions is termed as true volume.
The granular volume
The cumulative volume occupied by the particles, including all intraparticulate voids.
Voids
Air spaces between particles is called voids.
Open intraparticulate voids
Air spaces within a single particle but open to the external environment.
Closed intraparticulate voids
Air spaces within a single particle but closed to the external environment.
Interparticulate voids
The air spaces between individual particles.
Moisture Content
Measurement of the moisture in a wet solid on a dry weight basis is called moisture content.
Loss on Drying
The expression of moisture content on a wet-weigth basis
Calibration
Calibration is a process of configuring an instrument to provide a result for a sample within an acceptable range.
Chapter: Biopharmaceutics
Table of Content
Bioavilability
Potency
Efficacy
Loading dose
Maintenance dose
Cmax
Tmax
AUC
Volume of distribution
Bioavailability
Bioavailability means the rate and extent to which the active ingredient or moiety is apsorbed from a drug product and is available at the site of action.
IV Bolus dose
IV bolus dose is a single dose of a drug or other medicated preparation given all at once at a faster rate for rapid delivery of drugs into the bloodstream using needle and syringe.
Loading Dose
Loading dose is an initial higher dose of a drug that may be given at the beginning of a course of treatment before dropping down at a lower maintenance dose.
Maintenance dose
Chapter: Microbiology
LAL test (Lymulus amoebocyte lysate test)
It is an in vitro test for bacterial endotoxin or pyrogen use a lysate of amoebocyte from the horsesoe crab Limulus polyphemus.
Bioburden test
It is the measurement of microbial contamination level in a product.
What is Sterilization
Sterilization is the process by which all viable microorganisms including spores are killed or eliminated.
Chatper: Research and Development
Product development
The process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery is termed as product development.
Stability study
It is study to determine the shelf-life of a product i.e. how much time the product remain stable in the market and confirms with product specification meet the pharmaceutical limit.
Preformulation Studies
Before the formulation of new drug substance into a dosage form, it is essential to ascertain certain fundamental physical and chemical properties of the drug molecule and other derived properties of the drug powder. This first phase of learning is known as preformulation studies.
Small scale Batch
A small scale batch of a drug product produced in preparation for a full scale batch. Pilot scale batches help researchers develop techniques that will be required to create much larger batch needed for clinical trial and later, manufacturing of approved products.
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