Advisory Services

Quality  Managment

Analytical Method:

Analytical method defines that technical procedure for determining one or more specific characteristics of a product or material.

Analytical Report:

The document which contains the results of the analyses and any other information relating to the test.

Active Pharmaceutical Ingredient:

Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or affect the structure and function of body.

Agreement.

Arrangement undertaken by and legally binding on parties.

Acceptance Criteria:

Measurable terms under which a test result will be considered acceptable.

Action Limit:

Action limit is reached when the acceptance criteria of a critical parameter have been exceeded. Results at these limits will require specified action and investigation.

Air Handling Unit (AHU):

Air handling unit which serves to condition the air and provide the required air movement within a facility.

Airlock:

An enclosed space with two or more doors, which is interposed two or more rooms. e.g. of differing classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need to be entered. An airlock is designed for and used by either people or goods (PAL = Personnel airlock and MAL = Material airlock).

Alert limit:

Alert limit is reached when the normal operating range of a critical parameter has been exceeded, indicating that corrective measures may need to be taken to prevent the action limit being reached.

ASHRAE:

American Society of Heating, Refrigeration and Air Conditioning Engineers.

Active Ingredients:

That portion of a medicine (drug) that has therapeutic properties.

Basic Unit:

The smallest unit in which a medicine can be conveniently dispensed or administered. It is used in quantification, reorder formals and comparison of prices of different sized bottles or vials. Typical basic units are tablet or capsule, mL (for liquids) and grams (for ointments and creams).

Bioavailability:

The rate and extent of availability of an active ingredient from a dosage form as measured by the concentration/time curve in the systemic circulation or its excretion in the urine.

Branded Generics:

Generic (off-Patent) pharmaceutical products marketed under brand names.

Broker:

Person licensed to sell goods; middleman business.

Bulk product:

Any product that has completed all processing stages up to, but not including, final packaging.

Biopharmaceutics

Study of the influence of formulation on the therapeutic activity of a drug product.

Bulk Product:

Any product that has completed all processing stages up to, but not including, final packaging.

Batch

A defined quantity of starting material, packaging material or product processed in a single process or series of processes so that can be expected to be homogeneous. It may sometimes be necessary to divide a batch into a number of sub-batches which are later brought to final form of homogeneous batch.

Batch number.

A distinctive combination of numbers and/or letters which uniquely identifies a batch on labels, the batch records, the certificates of analysis etc.

Bioequivalence:

Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilities (rate and extent), after administration in the same molar dose, are similar to such a degree that their effects can be expected to be essentially the same.

Confidence intervals:

Confidence intervals are a range of values within which the true population value probably lies.

Constraint:

A characteristic proper to the internal and/or external environment that can impede or block the realization of an objective, but that one cannot eliminate. A constraint, one must live with it.

Clean Area (clean room):

A area (or room) with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generating and retention of contaminants within the area.

Calibration.

The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (specially weighing),recording and controlling, or the values represented by a material measure and the corresponding known values of reference slandered .Limits for acceptance of the results of measuring should be established.

Container labeling.

All information that appear on any part of a container, including that on any outer packaging such as a carton.

Contamination.

The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a starting material, intermediate or finished product during production sampling, packaging or repackaging ,storage or transport.

Cross-Contamination.

Contamination of starting material, intermediate product or finished pharmaceutical product with another starting material or product.

Counterfeit Drug:

A counterfeit drug is one which is deliberately and fraudulently mislabeled with respect to identity and / or source. The term counterfeiting can apply to both branded and generic products, and counterfeit products may include products with correct ingredients, wrong ingredients, without active ingredients, with incorrect quantity of active ingredient or with fake packaging.

Contract.

Business agreement for the supply of goods or performance of work at a specified price.

Clinical Pharmacist:

An individual trained in pharmacy, usually at bachelor’s degree level, who has had specialized training in the uses, side-effects, contraindications and dosages of medications for human uses.

Compounding:

To mix together the ingredients of a prescription of drug formula. Generally refers to a manual process performed for individual orders by a dispenser or pharmacist.

Consumption:

The rate at which items are issued to clients or patients. This is also called demand (which is in strict terms, the rate of requests or orders.) Consumption is usually measured in terms of units consumed within a specific period.

Delegation:

The assignment by a manager of an activity, tasks, defined scope of authority, or responsibility to a staff member under the manager’s supervision.

Delivery System:

Drug distribution system in which the warehouse is responsible for providing transport of supplies from the warehouse to the health facilities.

Disintegration:

The breaking up of a tablet or capsule in to granules or aggregates in an aqueous fluid.

Dispense:

To prepare and distribute to a patient a course of therapy on the basis of a prescription.

Dispenser:

A general term for anyone who dispenses medicine. Also specifically used to mean an individual who is not a graduate pharmacist but is trained to dispense medications, maintain stock records and assist in procurement activities.

Dissolution:

The breaking down of fine particles into molecules or ions homogeneously dispersed in an aqueous fluid.

Or

Dissolution is the process by which a solid or liquid forms a homogeneous mixture with a solvent (solution).

Distribution system:

A system of administrative procedures, transport facilities, storage facilities and user facilities through which supplies move from a central point to the user facilities.

Drug:

Any substance in a pharmaceutical product that is used to modify or explore physiological systems or pathological states for the benefit of recipient.

Drug product:

A unique combination of drug or drugs, strength and dosage form (for example, ampicillin 500 mg capsule).

Drug use:

The process of diagnoses, prescribing, labeling, packaging and dispensing and adherence to drug treatment by patients.

Distribution:

The division and movement of pharmaceutical products from the premises of the manufacturer of such product ,or another central point ,to the end user thereof, or to an intermediate point by means of various transport methods ,via various storage and/or user facilities.

Dosage Form:

The form of the completed pharmaceutical product, e.g. Tablet, Capsule, Injections, Elixir, Suppository.

Distributor:

A person or entity that distributes or oversees the distribution of pharmaceutical products through the distribution system.

Drug (medicine, pharmaceutical product, pharmaceutical):

Any substance or mixture of substance that is manufactured for sale or distribution, offered for sale, sold, supplied or presented for use in:

  • (1) The treatment ,mitigation cure, prevention or diagnosis, an abnormal physical state or the symptoms thereof in humans or animals
  • (2) Normal physiological condition in humans or animals; or
  • (3) The restoration, correction or modification of organic function in humans or animals, or any substance in a pharmaceutical product that is used to modify or explore or physiological system or pathological states for the benefit of the recipient.

Drug Regulatory Authority:

A national body that administers the full spectrum of drug regulatory activities, including at least all of the following functions:

  • Marketing authorization of new products and variation of existing products.
  • Quality control laboratory testing.
  • Adverse drug reaction monitoring.
  • Provision of drug information and promotion of rational drug use.
  • Good manufacturing inspections and licensing of manufacturers, wholesalers and distribution channels.
  • Enforcement operations.
  • Monitoring of drug utilization.

Excepient

A substance, other than the active ingredient, that is intended or designated to be used in the manufacturer of pharmaceutical product.

Essential Drugs:

Essential drugs are those that satisfy the health care needs of the majority of the population. Each country may generate its own list of essential drugs.

Equipment:

Equipment is considered to be all apparatus necessary for carrying out analytical processes, but which don’t provide quantitative results for these, such as autoclaves, ovens, laminar flow and gas extraction hoods.

Evaluation:

Constant process of comparison of the results obtained from activities carried out by evaluating group, which are used to measure selectively the efficiency, efficacy and congruence of the administrative programs of the laboratory for preventive purpose.

Efficacy:

The ability of a drug to produce the purported effect, as determined by scientific methods.

Expiry date:

The date appearing on a pharmaceutical product and established by the manufacturer, beyond which the manufacturer will not guarantee the potency, purity, uniformity, or bioavailability of the product.

Or

The date placed on the container of a pharmaceutical product or starting material which designates the date up to and including which the pharmaceutical product is expected to remain within specification if stored correctly. It is established for each batch by adding the shelf-life period to the date of manufacturer.

Finished Product:

A product that has undergone all stages of production, including packaging in its final container and labeling and is available in presentable form.

Formulation:

A composition of a dosage form, including the characteristics of its raw materials and the operations required to process it.

First Expiry/First out Procedure (FEFO):

A method of inventory management in which products with the earliest expiry dates are the first products issued, regardless of the order in which they are received. This method is more demanding than FIFO but should be used for short dated products such as vaccines.

First In/First out Procedure (FIFO):

A method of inventory management in which the first products received are the first products issued. This method generally minimizes the chance of drug expiration.

Formulary List:

A list of medicines approved for use in a specific health care system.

Formulary manual:

A manual containing clinically oriented summary pharmacological information about a selected number of medicines. The manual may also include administrative and regulatory information pertaining to medicine prescribing and dispensing.

Formulary system:

The principles, criteria, procedures, and resources for developing, updating, and promoting the formulary list (essential medicine.)

Generic name:

The approved or non-proprietary name of a drug.

Generic pharmaceutical products:

Products marketed by any producer under non-proprietary or approved names.

Generic substitution:

Dispensing of a product that is generically equivalent to the prescribed product, with the same active ingredients in the same dosage form, and identical in strength, concentration and route of administration.

GMP (Good Manufacturing Practices):

Performance standards for pharmaceutical manufacturers established by WHO and many national governments; they include criteria for personnel, facilities, equipment, materials, manufacturing operations, labeling, packaging, quality control, and stability testing.

Or

Good Manufacturing Practices are that part of quality which ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.

Goal:

The general aim toward which the organization or programme is striving.

Good Clinical Practice (GCP):

GCP is a standard for clinical; studies which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies and which ensures that the studies are scientifically and ethically sound and that the clinical properties of the diagnostic/ therapeutic/prophylactic product under investigation are properly documented.

Good Laboratory Practice (GLP):

GLP can be considered as a set of criteria to be satisfied as a basis for validating results and conclusions generated in laboratory studies. It defines an approach to the management of laboratory studies that provides a record of what has been done in a way that is both transparent and amenable to meaningful inspection.

Good Engineering Practice (GEP):

Established engineering methods and standards that are applied throughout the project lifecycle to deliver appropriate, cost-effective solutions.

HEPA filter

High Efficiency Particulate Air filter.

HVAC:

Heating Ventilation and Air-conditioning.

Homogeneous:

Consisting of parts of all the same kind, uniform.

Immediate Release Dosage Form:

A dosage form that is intended to release the entire active ingredient on administration with no enhanced, delayed or extended release effect.

Innovator Pharmaceutical Product:

The innovator pharmaceutical product is generally that which was first authorized for marketing (normally as a patented product) on the basis of documentation of efficacy, safety and quality (according to requirements at the time of the authorization). When a substance has been available for many years, it may not be possible to identify an innovator pharmaceutical product.

In process Quality control:

Checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product confirms to its specifications. The control of the environment or equipment may also be regarded as a part f in-process control.

Intermediate product:

Partly processed during production in order to undergo further manufacturing steps before it becomes a bulk product.

Instruments:

Apparatus used in the various analytical methods and which provides quantitative results e.g. UV/VIS, IR spectrophotometer, gas chromatograph, liquid chromatograph.

Implementation:

The second step in the management cycle; the process putting a plan into action by organizing and directing the work. It involves managing people, money, information and other resources to achieve intended results.

Indicator:

Criterion used to measure changes, directly or in-directly, and to assess the extent to which the targets and objectives of a programme or project are being attained. Indicators should meet the criteria of clarity, usefulness, measurability, reliability, validity, and acceptance by the key stakeholders.

Indicator drug:

One of a small number of representative drugs, also known as tracer or index drugs, selected to be used with performance indicators to assess the performance of a drug supply system.

Inventory:

The total stock kept on hand at any storage point to protect against uncertainty, permit bulk purchasing, minimize waiting time, increase transportation efficiency and buffer against seasonal fluctuations.

Or

Itemized list of goods with their estimated cost.

Inventory control:

The function of supply management that aims to provide sufficient stocks of medicine at the lowest costs possible.

Irrational prescribing:

Prescribing that does not conform to good standards of treatment, for example extravagant prescribing, over prescribing, incorrect prescribing, and multiple prescribing or under prescribing of medication.

Issue unit:

The quantity or size of each item counted as one inventory issue unit in the stock record. For example, in some supply systems the unit for tetracycline capsules might be one bottle of hundred capsules; in others it might be one capsule. This is not necessarily the same as the basic unit or comparison unit, although they maybe the same.

Item:

A unique product for inventory purposes. In drug supply, an important issue is whether generic equivalent items are treated as the same items or whether different brands of the same generic products are treated as different items. The item is sometimes called as stock-keeping unit (SKU.)

Labeling

The action involving the selection of correct label, with the required information, followed by the line clearance and application of the label to the container.

Material:

A general term used to denote starting materials (active pharmaceutical ingredients (API) and excepients), reagents, solvents, process aids, and intermediates, packaging materials and labeling materials.

Master Formula:

A document or set of documents specifying the starting materials with their quantities and packaging materials, together with the description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing interactions including in process controls.

Master Plan:

Document that contain a detailed analysis of the sector, which identifies problems and defines objectives, strategies and activities susceptible to resolve problem of the sector during given period.

Manufacturer:

A company that carries out at least one step of manufacture.

Medicinal Product:

Any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances that may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting, or modifying physiological functions in human beings or in animals is like wise considered a medicinal product.

Manufacturing:

Under the good practices for the Manufacture and Quality Control of drugs issued by WHO, manufacturing is all operations involved in the production of a drug including processing, compounding, formulating, filling, packaging and labeling.

Marketing authorization:

An official document issued by the competent drug regulatory authority for the purchase of the purpose of marketing or free distribution of a product after evaluation for safety, efficacy and quality. It must set out, inter alia, the name of product, the pharmaceutical dosage form, the quantities formula (including excipients) per unit dose (using international nonproprietary names or national generic names where that exist), the shelf-life and storage conditions and packaging characteristics. It also contains information approved for health professionals and the public, the sales category, the name and address of the license holder, and the period of the validity of the license.

Management Cycle:

The process consisting of the three inter connected functions of planning, implementing, monitoring and evaluation.

Medicine:

Any substance in a pharmaceutical product that is used to modify or explore physiological systems or pathological states for the benefit of the recipient.

Monitoring:

The ongoing process reviewing the degree to which programme activities are completed and objectives are being met, to allow for corrective to be taken during implementation.

New Pharmaceutical Product:

A pharmaceutical product that contains a new API, a new combination of marketed APIs, or a new multisource (Generic) product. It may be available either on prescription or without prescription.

National Measurements Standard:

Authorized standard for obtaining, setting or comparing the values of other standard of the same magnitude, which serves as a basis for setting the values of all standards of the given magnitude.

Norm or Written Standard:

Document stated the accepted rules for carrying out a specific test.

Normal operating range:

Normal operating range is the range that the manufacturer selects as the acceptable values for a parameter during normal operations. This range must be within the operating range.

Operating limits:

The minimum and/or maximum values that will ensure that product and safety requirements are met.

Operating Range:

Operating range is the range of validated critical parameters within which acceptable products can be manufactured.

Objective:

Is the end result a programmer seeks to achieve.

Obstacle:

Bottleneck in the external and/or internal environment that can impede or block the realization of an object. Unlike a constraint, an obstacle can b eliminated by an appropriate strategy.

Packaging:

All operations, including filling and labeling, which a bulk product has to undergo in order to become a finished product.

Note: Sterile filling would not normally be regulated as part of packaging, the bulk product being the filled, but not the finally packaged, primary container.

Policy:

Declaration of intent in which the Government commits itself, on the basis of a number of values and principles, to achieve a number of objectives to resolve specific problems of the sector by implementing appropriate strategies. Any policy should set the goals, objectives and strategies required to resolve the major problems identified in the sector.

Problem:

Gap between actual and desired situation.

Programmes

Organized aggregate of activities directed towards the attainment of defined objectives related to one or several specific problems.

Project:

Is what one purposes to do. It is a series of interconnected activities established to achieve a defined objective in specified defined time period.

Plan:

Document that contain a group of programmes/projects and strategies explicitly expressed in order to attain an objective or a group of objectives.

Pharmaceutical:

Any medicine intended for human use or veterinary product administered to food producing animals, presented in its finished dosage form or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation in both the exporting state and the importing state.

Production:

All operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing and packaging, to completion of the finished product.

Personnel:

  • At each storage site (e.g. manufacturer, wholesaler, community and hospital pharmacy) there should be an adequate number of qualified personnel to achieve the pharmaceutical quality assurance objectives. If applicable national regulations on qualifications should be followed.
  • Proper training in relation to good storage practice and safety should be provided to all personnel.
  • All members of staff should observe high levels of personnel hygiene.
  • Personnel employed in storage areas should wear suitable protective or working garments over or in place of street clothing.

Pharmaceutical Equivalents:

Products are pharmaceutical equivalents if they contain the same amount of the same active substance(s) in the same dosage form; if they meet the same or comparable standards; and if they are intended to be administered by the same route. Pharmaceutical equivalence does not necessarily imply therapeutic equivalence as differences in the excipients and/or the manufacturing process can lead to differences in product performance.

Pharmaceutical Product:

Any preparation for human or veterinary use that is intended to modify or explore the physiological systems or pathological states for the benefits of the recipients.

Process Validation:

Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produced a product meeting its pre-defined specifications and quality attributes.

Pharmacist:

The holder of a degree or diploma in pharmacy from recognized higher institution of learning who is registered or licensed to practice pharmacy.

Pharmaceutical Product:

Any product intended for human or veterinary used presented in its finished dosage form that is intended to modify or explore physiological system or pathological states to the benefit of the recipient.

Primary packaging material:

Components (e.g. bottles, vials, blisters) in direct physical contact with the pharmaceutical product.

Production:

All operations involved in the preparations of a pharmaceutical product , from receipt of materials, through processing packaging and repackaging, labeling and Relabelling, to completion of the finished product.

Product recall:

Product recall is a process of withdrawing or removing a pharmaceutical product from the pharmaceutical distribution chain because of defects in the product, or complaints of serious reactions to the product. The recall might be initiated by the manufacturer / importer / distributor or responsible agency.

Potency:

The extent to which a medicine (drug) contains the specified amount of the active ingredient.

Prescribing:

The act of determining what medication the patient should have and the correct dosage and duration of treatment.

Procurement:

The process of acquiring supplies, including those obtained by purchase, donation and manufacture.

Purity:

The extent to which drugs are free from potentially harmful contaminants, significant quantities of other drugs, bacteria or other micro-organisms.

Quality assurance:

The management activities required to ensure that the drug reaches the patient is safe, effective and acceptable to the patient.

Or

Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of product. It is totality of arrangement made from the object of ensuring that pharmaceutical products are of the quality required for their intended used.

Or

Series of planned routine activities which a control laboratory carries out with the aim of offering adequate confidence that a product or service complies with the specified quality requirements.

Quality Control:

The testing of drug samples against specific standards of quality.

Or

Quality control covers all measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that starting materials, intermediates, packaging materials and finished pharmaceutical products confirm to established specifications for identity, strength, purity and other characteristics.

Or

Series of operating methods and activities which are used to satisfy compliance with the established quality requirements.

Or

That part of good manufacturing practice concerned with sampling, specifications and testing and with the organization, documentation and release procedure which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, or products released for sale or supply, until their quality has been judge to be satisfactory.

Quarantine:

The status of pharmaceutical products isolated physically or by other effective means (e.g. electronically) pending a decision on their subsequent approval or rejection.

Quality:

Series of characteristics of an element which make it capable of satisfying explicit and implicit requirements.

Or

The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.

Quality Improvement:

The actions taken in any organization to increase the effectiveness and efficiency of activities relating to a particular product, project or contract and processes in order to provide additional benefits, both for organization and its clients.

Quality Management: Series of activities of general function of management while determining quality policy, the objectives, responsibilities and implementation of these through measures such as planning, control, assurance and improvement of quality within the framework of the system.

Quality Manual:

Document which establishes the quality policies and describes the quality system of an organization.

Quality Plan:

Document which establishes the operating practices, procedures, resources and sequence of quality activities elating to a particular product, service, contract or project.

Quality Planning:

The activities which determine the objectives and requirements for quality, as well as implementation of the elements of the quality system.

Quality Policy:

Guidelines and general objectives of an organization concerning quality which are expressed formally by the senior management and supported by the authorities of the country.

Quality System:

Organizational structure, including resources, responsibilities and established procedures to ensure that products, processes or service comply satisfactorily with their intended purpose, directed to achieving quality.

Quality Assurance Program:

An internal control system designed to ascertain that the preclinical study is incompliance with principles of GLP or clinical trials incompliance with principles of GCP.

Reference Material:

A material or substance one or more of whose property values are sufficiently homogenous and well established to be used for the calibration of a apparatus, the assessment of a measurement method, or for assigning values to the test material.

Registration/Authorization:

Any statutory system of approval required at national level as a preconditioned for introducing a pharmaceutical product onto the market.

Reference Product or Comparator Product:

A reference product is a pharmaceutical product with which the new product is intended to be interchangeable in clinical practice. The reference product will normally be the innovator product for which efficacy, safety and quality has been established, where the innovator product is not available, the product which is the market leader may be used as a reference product, provided that it has been authorized for marketing and its efficacy, safety and quality have been established and documented.

Regulation:

Rules issued by a government agency like the “US, FDA” after a proposal and comment period.

Regulations generally explain and expound laws.

Relabelling

Process of putting a new label on the product.

Re packaging:

Action of changing the packaging of the product.

Raw material:

A general system used to denote starting materials, reagents, intermediates, process aids and solvents intended for use in the production of APIs.

Retest Date:

The date when a product should be re-examined to ensure that it is suitable for use.

Sampling:

Operations designed to obtain a representative portion of a pharmaceutical product, based on an appropriate statistical procedure, for a defined purpose, e.g. acceptance of consignment, batch release, etc.

Skip lot testing:

Periodic or skip testing is the performance of specified tests at release on pre selected batches and/or at predetermined intervals, rather than on a batch-to-batch basis, with the understanding that those batches not being tested must still meet all acceptance criteria established for that product.

Standard operating procedure (SOP):

An authorized written procedure, giving instructions for performing operations, not necessarily specific to a given product or material, but of a more general nature, (e.g. equipment operation, maintenance and cleaning, validation, cleaning of premises and environmental control, sampling and inspection). Certain SOPs may be used to supplement product-specific master and batch production documentation.

Or

Written description of all manufacturing operations, including control tests to be carried out for the production of a product meeting certain specifications.

Storage:

The storage of pharmaceutical products up to their point use.

Shelf Life (Expiration Dating Period or Validity Period):

The period of time during which a drug product is expected, if stored correctly, to remain within the specifications as determined by stability studies on a number of batches of the product. The shelf life is used to establish the expiry date of each batch.

Specifications:

Explicit written criteria for manufacturing or testing a product it is the requirement against which the acceptability of the inputs or outputs of a process are to be judged. Specifications describe the starting materials, packaging materials, intermediate, bulk or finished products in terms of their chemical, physical and biological characteristics.

Strategy:

A broad plan of action for fulfilling a programme’s basic purpose and achieving it’s main goals.

Or

IS an approach or a way to achieve an objective and to eliminate obstacles or to bypass policy constraints of the internal or external environment that may impede or block the achievement or a policy.

Standards:

Values or norms towards which all actions converge. It is one the basis of standards or values that polices are formulated.

Starting Material (Raw Material):

Any substance of a defined quality used in the production of a pharmaceutical product, but excluding packaging materials.

Shelf-life:

The length of time a material maybe stored without affecting its usability, safety, purity, and potency.

Stock:

Goods and materials stored for future use.

Stock Records:

A generic that applies to card record systems, stock ledgers and computer files. These provide basic information for inventory management by recording all transactions for an item, including receipts, issues, orders placed, orders received and stock losses.

Stockout

Complete absence of an item that is normally expected to be on hand. In many cases, this can be misleading as an indicator because a warehouse may always reserve a small stock. The warehouse is not literally out of stock, but there is a functional stock out because the warehouse will not issue the reserved stock.

Supervise:

To oversee; to provide direction; to guide and instruct with immediate responsibility for performance.

Supplier

Any individual or company that agree to provide medications, regardless of whether that party is the manufacturer.

Symbollic labeling:

A system of providing written instructions for patients using sketches and other graphic representations.

Solvent:

An inorganic or organic liquid used as a vehicle for the preparations of solutions or suspensions in the manufacture of an AIP, its starting material, intermediate and drug product.

Stability:

The ability of an active ingredient or a drug product to retain its properties within specified limits throughout its shelf life. The chemical, physical, microbiological and biopharmaceutical aspects of stability must be considered.

Therapeutic Equivalence:

Two pharmaceutical products are therapeutically equivalent if they are pharmaceutically equivalent and, after administration in the same molar dose, their effects with respect to both efficacy and safety are essentially the same, as determined from appropriate bioequivalence, pharmacodynamic, clinical or in vitro studies.

Trader:

Person engaged in trade.

Targets:

Meausreable, time-limited, intermediate progress points toward objectives; also called milestones.

Therapeutic category analysis:

The analysis of expenditures by therapeutic category, for comparison with morbidity patterns and public health priorities, as a means of focusing cost control efforts.

Therapeutic equvalents:

Pharmaceutically equivalent products whose effects with respect to both safety and efficacy are essentially the same, when administered in the same molar dose, as can be derived from appropriate studies (bioequivalence, pharmacodynamic, clinical, or in-virto studies).

Therapeutic subsitution

Interchange of one pharmaceutical product with another that differs in comparison but is considered to have similar pharmacologic and therapeutic activities in accordance with written protocols previously established and approved.

Test period:

The period of time during which the APIs, materials used for their production, excipients and packaging materials can be considered as remaining within the specification and therefore acceptable for use in the manufacturer of a given product, provided that it has been stored under the defined conditions; after this period, the batch should be retested for compliance with specification.

Test:

Technical operation which involves the determination of one or several characteristics of a given product, process or service according to a specified procedure.

ULPA filter:

Ultra-Low Penetration Air filter (not applicable to normal pharmaceutical installations, but given for background information).

Unidirectional airflow:

Unidirectional airflow is a rectified airflow over the entire cross-sectional area of a clean zone with a steady velocity and approximately parallel streamlines.

Validation:

The documented act providing that any procedure, process, equipment, product, activity or system actually to the expected results.

Vehicle:

Vehicle refers to trucks, vans, buses, minibuses, cars, trailers, aircraft, railway carriages, boats and other means which are used to convey pharmaceutical products.

Validation:

Actions of proving that a procedure, process, system, equipment or method used in manufacturing and controlling a product works as expected and achieves the intended results.

Or

The demonstration with documentary evidence, that any procedure, process, equipment, material, activity, or system actually leads to expected results.

VEN system:

A system of setting priorities for purchasing drugs and keeping stock, in which drugs are divided according to their health impact into vital, essential, and non-essential categories.

Verification:

A series of operations to check that a piece of equipment, an apparatus or an instrument functions within the permissible limits.

Working Standard or Reference:

Also called Secondary Standard .

A reference material whose value is fixed by comparison with a primary standard of a reference material. In the vast majority cases, reference materials such as a National Standard and laboratory standard are secondary standards.

Wholesaler:

A dealer who purchases supplies from a manufacturer and resells them to the ultimate buyers.