A standard document, which give instructions to the Production Department to produce a pharmaceutical product for distribution/sale in the market;

A section of the warehouse which houses products which have been bottled, stripped or blister-packed, but not yet labelled or packed into boxes/cartons. And are still awaiting the final disposition of the Quality Control Department;

The Planning and Scheduling Division coordinates with this department on what products are required for supply and market distribution, then plans and schedules the manufacture of the product;

A method of filling liquids wherein the product is pumped, at constant pressure, through an orifice of constant diameter and size. The fill amount is measured by the stroke of the piston;

An important parameter in the quality control of tablets, shown to be related to the tablet’s solubility properties;

A special technique for poorly-soluble drugs, in which it is improved by the addition of a water-miscible solvent, in which the drug will have increased water solubility;

A class of preservative, which are often used for ophthalmic, nasal and parenteral products, but in oral liquid preparations;

A filter media composed of nylon, Teflon, PVC and silver. It is employed fo the micro-filtration of parenteral solution;

The following are the effects of Product Recalls to a drug-manufacturing firm;

Overages in the manufacture of pharmaceuticals are justified on the ff. conditions;

It refers to the addition of an active in an unstable pharmaceutical preparation, to compensate for the loss during manufacture;

It refers to the rapid formation of emulsion droplets or aggregates due to the absence of a protective barrier at the oil-water interface and the insufficient emulsifier surface overage;

For the pharmaceutical emulsions, the oil phase is restricted to this oil, unless otherwise, it is the specified active of the product;

A class of finely divided solids that influence emulsification of polar solids by its tendency to be wetted by water, and to be wetted by the oil phase of non-polar solids;

Examples of antioxidants incorporated into cosmetic type of emulsion;

An equipment that mixes the components of emulsions by means of various impellers on shafts, which are placed directly into the system to be emulsified;

Raw materials of hydrocarbon nature, which are widely used in the manufacture of semi-solids, next to water;

Raw materials which are widely used as humectants in semi-solids to prevent “crusting” in ointment and creams contained in jars;

An absorption type of an ointment used for ophthalmic preparations;

A method of manufacture of anhydrous ointments wherein the active/s are dissolved in the previously melted mixtures of fats and waxes, at controlled temperatures;

A type of stability test, which involves temperatures in 10-degree increments. This test is performed to identify the products of degradation of a product;

A method of preparation of suspensions, wherein finely divided powders are dispersed in an appropriate liquid vehicle, with the aid of a surfactant, to ensure uniform wetting of hydrophobic surfaces;

The cause of capping, chipping and lamination of compressed tablets;

In precipitation method of preparing suspensions, particle size control is important. For suspensions intended for parenteral and inhalation us, the ideal particle size range is;

This equipment produces finely divided particles by spraying a mist of liquid through a heated chamber, drying immediately and collecting the dried powders in a clean receptacle;

A parenteral route of administration in which an aqueous solution is preferred for optimum absorption. It produces instantaneous pharmacological effect, since the drug is directly introduced into the bloodstream;

The potential sources of pyrogens in the manufacture of parenterals;

Air sampling techniques used for the environmental control test in the parenteral work area;

An equipment, which allows for the draft-free flow of air cover over the parenteral work area, by providing a total sweep of the confined area;

When filling sterile powders into vials, the filling equipment employs a/an____in the stem of the funnel at the bottom of the hopper. It regulates the volume of granular material into the vial to avoid clogging;

Process/es that give/s rubber closure less friction, to enable easier mechanical insertion onto vials;

A more effective method of sterilization. Killing microorganisms through coagulation of its cell protein. It also destroys vegetative forms of bacteria and spores at 121 C for 20 minutes at 20 psi;

A non- thermal form of sterilization, which is used in the reduction of air-borne microbes, roduced by mercury vapour lamps. This method has poor penetration capability;

An in-vitro method of pyrogen test based on the gelling or color development of pyrogenic preparation in the presence of lysate on the amoebecytes of the horseshoe crab;

Most biological are store at this temperature;

Parenteral products, which should be packed as single-dose medication;

Examples of primary packaging components;

A mechanism involved in the preparation of sustained release tablets, wherein the drug material is applied with relatively thin coating material, ranging from several tenths of micron to 5000 microns in size;

A part of tablet press, which distributes the granulation material into the die cavities;

An ideal property of tablet granulations in which the material forms a stable, compact mass when pressure is applied;

The preferred bulking agent for chewable tablets, which provides an excellent mouth-feel, due to its pleasant, cooling effect;

This raw material can be used as a tablet diluents, disintegrant and binder;

The ff. statements are true for glidants/lubricants in tablet granulation;

Carbowax 400, leucine, talc and colloidal silicon dioxide are employed as____.

A method of preparation of tablets whose components are sensitive to moisture and elevated temperatures, during drying, yet possess inherent cohesive properties;

A method of preparing tablet granulations, wherein the powders are de-aerated and passes between two rollers, forming a thin cake, which is screened to form granules;

An equipment, which alternately combine and draw apart the tablet material, as this equipment revolves. Ideal for precise blending of dry-to-dry or dry-to-liquid materials, with short processing times;

An equipment, which delivers a reliable and uniformly mixed dried product, without the necessity for pre-mixing. It produces a dry granulation from a wet powder mix;

The critical operation in sugar coating process of tablets leading to a 50% to 100% increase in tablet weight. This is the basis of an elegant tablet profile;

An enteric film-former material, which is not soluble in a slightly acid pH media;

It refers to the separation of the concentrated emulsified droplets from the discontinuous phase;

A type of gelatine blend, which contributes to plasticity and clarity to the blend, thus reducing haze or cloudiness of the finished capsules;

The most common method of manufacture of hard gelatine capsules that uses completely automatic machine, consisting of mechanisms for dipping, spinning, drying, stripping and joining the capsules;

The temperature at which empty hard gelatine capsules should be stored;

Aside from the property of fluidity, tablet granulations should also possess;

Pharmaceutical suspensions are evaluated by;

The coalescence of globules in an oil-in-water emulsion is an indication of;

An adjunct used to prevent topical preparations from drying out of forming a “crust” of the surface;

Anteroom, which separates the sterile areas from non-sterile areas;

CGMP means;

Suppositories are made by;

USP requires that Dissolution Test should be carried out at;

LAL stands for;

In real Time stability studies, the climatic conditions of the Philippines is classified as;

Long term stability studies, is also known as;

Directly Compressible grades of Lactose include;

Sterilization technique. Which makes use of ethylene oxide-beta propiolactone or propylene oxide, usually for plastic containers;

Diluents of choice or chewable tablets;

Strip-sealed tablets are evaluated for;

An equipment associated with the maintenance of dust-free;

Binder of choice for moisture-sensitive materials;

An adjunct necessity for oral liquids to prevent bacterial contamination;

“Rule of Thumb” is the principle applied for testing;

Thermolabile products in solution is sterilized by;

A tablet formulation contains 2 actives, which are chemically incompatible. The best method to be used is;

Freeze-drying is also known as;

According to the USP, single dose containers of parenterals are limited to fill volume of;

For rapid disintegration of compressed tablets, the concentration starch to used is;

In the preparation of effervescent tablets, the component/s necessary for the effervescent effect is/are;

Manufacturing tanks of oral liquids are usually constructed of;

Eggyolk, an emulsifier belongs to;

Uneven distribution of color on the surface of compressed tablets is called;

Parenteral solutions intended to be freeze-dried should be;

A common lubricant added to tablet granulation;

Limulus amoebocyte lysate is obtained from;

A broad-spectrum preservative effective against bacteria and molds;

Inconsistent thickness of tablets could result to problems regarding;

Stoke’s Monsanto tester is used to measure___of tablets;

In the manufacture of emulsified semi-solids, the mixing of the oil aqueous phases should be at this temperature to avoid breaking;

The bioavailabilty of a compressed tablet is dependent upon its;

An inert gas usually incorporated in filling ampoules;

The normal moisture content of hard gelatine capsules;

This statement is true of the FIFO Policy;

Which of these is the adverse effect of a product recall?

Which of the ff. Is the function of Research and Product Development Department?

Pyrogens contaminating glasswares can be destroyed at this setting;

Water soluble bases for medicated application are prepared from;

A solid dosage form, which does not need to conform to USP disintegration time;

An instrument used to check the tightness of the caps/closure;