Pharmaceutical Manufacturing Lec

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Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. (Substances which give a medicinal product its therapeutic effect). Also known as “Active Substance” or “Drug Substance”.

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API

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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 airflow between those rooms when they need to be entered. An air lock is designed for and used by either people or goods.

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Airlock

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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.

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Batch or Lot

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NUMBER) A distinctive combination of number and/or letters which specifically identifies a batch.

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Batch Number or Lot Number

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Microorganisms, including genetically engineered microorganisms, cell cultures and endoparasites, whether pathogenic or not.

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Biological Agents

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

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Bulk Product

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The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, and the corresponding known values of a reference standard.

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Calibration

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The correct manufacture of medicinal products relies upon

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People

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The manufacturer must have an_______ in which the relationships between the heads of production, quality control and where applicable head of quality assurance, and the position of qualified persons are clearly shown in the ____________.

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Organizational chart, managerial hierarchy

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Newly recruited personnel should receive training appropriate to the duties assigned to them.

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Training

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Visitors or untrained personnel are not to be taken into the production and quality control areas.

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Training

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The manufacturer should provide training for all the personnel whose duties take them into production and storage areas or into control laboratories, and for other personnel whose activities could affect the quality of the product.

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Training

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Personnel working in areas where contamination is a hazard should be given specific training (e.g. clean areas, areas where highly active, toxic, infectious or sensitizing materials are handled)

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Training

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Personnel should wear protective garments appropriate to the operations to be carried out.

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Personal Hygiene

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No person affected by an infectious disease or having open lesions on the exposed surface of the body is engaged in the manufacture of medicinal products.

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Personal hygiene

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All personnel should receive medical examination upon recruitment.

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Personal Hygiene

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Personnel should be instructed to use the hand-washing facilities.

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Personal Hygiene

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Direct contact should be avoided between the operator’s hands and the exposed product as well as with any part of the equipment that comes in contact with the products.

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Personal hygiene

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Eating, drinking, chewing, or smoking or the storage of food, drinks, smoking materials or personal medication in the production and storage areas should be prohibited.

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Personal Hygiene

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must be located, designed, constructed, adapted and maintained to suit the operations to be carried out.

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Premises and Equipment

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The design of the facility is based upon the specification of certain___

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Design Parameters

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determined by the using organization consistent with the level of nonviable and viable particulate contamination acceptable to the process conducted within the facility.

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Cleanliness Classification

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rely on air dilution as well as a general ceiling-to- floor airflow pattern to continuously remove contaminants generated within the room.

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Non- unidirectional flow

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more effective in continuously sweeping particles from the air due to the piston effect created by the uniform air velocity

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Unidirectional flow

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determines the class of cleanliness that can be maintained during a given operation.

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Air change rate

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A pressure differential should be maintained between adjacent areas, with the cleaner area having the higher pressure. This will minimize infiltration of external contamination through leaks and during the opening and closing of personnel doors.

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Pressurization

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temperature of_____ will usually provide a comfortable environment for people wearing a typical lab coat.

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68-70 degree Fahrenheit or 18-20 degree celsius

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Where a full “ bunny suit ” or protective attire is to be worn, room temperature as low as?

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60 degree Fahrenheit

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The humidity requirement for comfort is in the range o

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30-60% RH

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Biopharmaceutical materials sensitive to humidity variations or excessively high or low values may require

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Stringent control

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support the process contained within the clean room

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Facility Layout

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is easiest to accommodate, other shapes may be incorporated into the facility as long as appropriate attention is paid to airflow patterns.

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Rectangular

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This is a room between the clean room and an unrated or less clean area surrounding the clean room or between two rooms of differing cleanliness class.

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Air Lock or Anteroom

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The purpose of the room is to maintain pressurization differentials between spaces of different cleanliness class while still permitting movement between the spaces.

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Air Locks or Anteroom

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An air lock can serve as a

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Gowning area

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recommended for air lock door sets to prevent opening of both doors simultaneously.

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Interlock

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recommended in interior clean - room walls to facilitate supervision and for safety, unless prohibited by the facility protocol for visual security reasons.

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Window

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Windows in ____building walls adjacent to a clean space are problematic.

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Exterior

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should be impact - resistant glass or acrylic, fully glazed, installed in a manner that eliminates or minimizes a ledge within the clean space.

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Window

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airlock should be provided for the transfer of products or materials from uncontrolled areas into the clean room or between areas of different cleanliness class

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Pass through

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The pass-through may include a_____ for communication when items are transferred and interlocks to prevent both doors from being opened at the same time.

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speaking diaphragm, intercom, or telephone

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installed at floor level can be used to simplify the movement of carts between clean areas.

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cart-size pass-through

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typically the material of choice for cart

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Stainless steel

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designed to support the garment protocol established for the facility.

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Gowning room

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specifically designed for cleanroom use

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Bench

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A typical gowning room may have a____ for clean garment storage

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wall-or floor-mounted coat rack

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Personal lockers and coat racks for the storage of notebooks, coats, and personal items should be located___ the gowning room or in an anteroom separate from the clean gowning area.

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Outside

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The walls should be strong enough to _____repeated impact of carts or other equipment without deterioration.

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Withstand

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______,easy-to-clean corners and smooth transitions between architectural features such as windows and walls should be featured in all wall system designs.

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Rounded

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Entry should be through airlocks to maintain clean-room pressure differentials.

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Door

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Commonly used floor finishes for biopharmaceutical clean rooms include____ installed using heat-welded or chemically fused seams to provide a seamless surface.______have also found wide use.

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sheet vinyl, Troweled epoxy and epoxy paint

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The level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk

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Quality Risk Management

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systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.

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Quality Risk Management

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The evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient.

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Quality Risk Management

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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.

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CLEAN AREA

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An area constructed and operated in such manner that will achieve the aims of both a clean area and a contained area at the same time.

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CLEAN/CONTAINED AREA

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The action of confining a biological agent or other entity within a defined space.

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CONTAINMENT

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An area constructed and operated in such a manner (and equipped with appropriate air handling and filtration) so as to prevent contamination of external environment by biological agents from within the area.

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CONTAINED AREA

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An area constructed and operated in such a manner that control the introduction of potential contamination, and the consequences of accidental release of living organisms.

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CONTROLLED AREA

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A system including the input of data, electronic processing and the output of information to be used either for reporting or automatic control.

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COMPUTERIZED SYSTEM

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Contamination of a material or of a product with another material or product.

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CROSS-CONTAMINATION

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Fresh or dried medicinal plant or parts thereof.

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CRUDE PLANT (VEGETABLE DRUG)

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

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CRYOGENIC VESSEL

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A container designed to contain gas ag a high pressure.

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CYLINDER

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Departure from an approved instruction or established standard.

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DEVIATION

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The dosage form in the final immediate packaging intended for marketing.

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DRUG PRODUCT

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Any constituent of a medicinal product other than the active substance and the packaging material

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EXCIPIENT

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The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf life specifications if store under defined conditions, and after which it should not be used.

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EXPIRY DATE

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A medicinal product which has undergone all stages of production, including packaging in its final container.

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FINISHED PRODUCT

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Medicinal product, containing, as active ingredients, exclusively plant material and /or vegetable drug preparations.

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HERBAL MEDICINAL PRODUCT

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Any component present in the intermediate or API that is not the desired entity.

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IMPURITY

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

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INFECTED

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

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INFECTED

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Checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms its specifications. (e.i. control of environment or equipment)

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IN-PROCESS CONTROL

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Partly processed material which must undergo further manufacturing steps before it becomes a bulk product.

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INTERMEDIATE PRODUCT

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All operations of purchase of materials and products, production, quality control, release, storage, distribution of medicinal products and the related controls.

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MANUFACTURE

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A company holding a “manufacturing authorization”

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MANUFACTURER

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Whole plant or part which is used for medicinal purposes.

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MEDICINAL PLANT

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

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PACKAGING

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Any material employed in the packaging of a medicinal product, 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.

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PACKAGING MATERIAL

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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 medicinal product.

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PROCEDURES