DOSAGE FORMS AND DRUG DELIVERY SYSTEMS CGMP & CGCP

Vocabulary flashcards covering key terms from the lecture notes.

CGMP

Current Good Manufacturing Practice - standards to ensure drug quality.

cGCP

Current Good Compounding Practice - standards related to pharmacy compounding.

API

Active Pharmaceutical Ingredient - any component that furnishes pharmacologic activity or other direct effect in diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the body.

Batch

A specific quantity of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture.

Batchwise control

Use of validated in-process sampling and testing methods to prove the process has performed as intended for the specific batch.

Certification

Documented testimony by qualified authorities that a system qualification, calibration, validation, or revalidation has been performed appropriately and the results are acceptable.

Compliance

Determination through inspection of the extent to which a manufacturer acts in accordance with regulations, standards, and practices.

Component

Any ingredient used in the manufacture of a drug product, including those not present in the finished product.

Drug product

A finished form that contains an active drug and inactive ingredients.

Inactive ingredient

Any component other than the active ingredient.

Lot

A batch or portion of a batch having uniform specified quality and a distinctive identifying lot number.

Lot number, control number, or batch number

Distinctive combination of letters, numbers, or symbols from which the complete history of manufacture, processing, packaging, holding, and distribution of a batch or lot of a drug product may be determined.

Master record

Record containing the formulation, specifications, manufacturing procedures, quality assurance requirements, and labeling of a finished product.

Quality assurance

Provision to all concerned the evidence needed to establish confidence that the activities relating to quality are being performed accurately.

Quality audit

A documented activity performed in accordance with established procedures on a planned, and periodic basis to verify compliance with the procedures to ensure quality.

Quality control

The regulatory process through which industry measures actual quality performance, compares it with standards, and acts on the difference.

Quality control unit

An organizational element designated by a firm to be responsible for the duties relating to quality control.

Quarantine

An area that is marked, designated, or set aside for the holding of incoming components prior to acceptance testing and qualification of use.

Representative sample

A sample that accurately portrays the whole.

Validation

Documented evidence that a system does what it purports what to do.

Process validation

Documented evidence that that a process does what it purpose what to do.

Validation protocol

A prospective experimental plan to produce documented evidence that the system has been validated.

Organization & Personnel

Quality control unit has authority and responsibility for all functions affecting product quality; all personnel must have proper education, training, and/or experience.

Building and facilities

Must have proper design, structure, and function; must meet water quality, sanitation and safety standards; separate areas for raw materials, packaging/labeling/testing, flammable materials, waste handling and sanitation.

Equipment

Must be of appropriate design, easy to clean, and suitable for intended use; written operating procedures required for use, cleaning and maintenance; automated equipment must be calibrated, maintained and validated.

Control of components, containers & closures

Written procedures for receipt, identification, storage, handling, sampling, and testing; raw materials quarantined until tested and approved; APIs from overseas tested for USP/NF compliance.

Production and process controls

Written procedures for identity, strength, quality and purity; in-process controls and testing required; automated systems must be regularly validated; containers of bulk products must be clearly labeled.

Packaging and labeling control

Written procedures for labeling to avoid mix-ups; all labels inspected for accuracy; expiration dated required to ensure stability and quality.

Tamper-evident packaging

Film wrapper or seals that indicate tampering; e.g., sealed packaging around product.

Holding and distribution

Written procedures for storage and distribution; distribution system must allow product recall.

Laboratory controls

Specification for testing, sampling, and standards; reserve samples kept for a certain period; test animals identified and records maintained.

Records and reports

Records kept for at least 1 year after product expiration; include production, control, distribution, equipment cleaning, and batch history.

Returned and salvaged product

Returned drug products identified by lot number and quality determined via testing; records maintained including date, reasons, quantity, lot number, and reprocessing procedures.

USP-NF guidelines for compounding

Chapters 795 (Nonsterile), 797 (Sterile), 800 (Hazardous drugs), 1160, 1163, 1176, 71, 85, 1151 related to compounding and dosage forms.

Packaging/containers

Well-closed, tight, hermetic, sterile hermetic, single-dose, multiple-dose containers; glass and plastic types and related tests.

Well-closed container

Protects contents from extraneous solids and loss under ordinary handling.

Tight container

Protects contents from contamination by extraneous liquids, solids or vapors; capable of tight reclosure.

Hermetic container

Impervious to air or any other gas under ordinary handling, shipment, storage, and distribution.

Sterile hermetic containers

Hold preparations intended for injection or parenteral administration.

Single-dose container

Holds a quantity of drug intended as a single dose, and when opened, cannot be resealed with assurance that sterility has been maintained.

Multiple-dose container

Hermetic container that permits withdrawal of successive portions of the contents without changing the strength or endangering the quality or purity of the remaining portion.

Glass containers (types 1- NP)

Type 1 (borosilicate glass); Type 2 (treated soda lime glass); Type 3 (soda-lime glass); Type NP (general purpose soda lime glass); each with different resistance characteristics.

Plastic containers

Advantages: lightweight, impact-resistant; disadvantages: permeability, leaching, sorption, deformation; common plastics: PET, PP, PVC.

Permeability

Allows oxygen/moisture to enter, affecting stability.

Leaching

Movement of container components into the contents.

Sorption

Contents sorbed by the container, reducing potency.

Deformation

Heat and handling stress can cause deformation affecting integrity.

Labeling

Information on product including net amount, Rx/OTC status, NDC, expiration, and other details.

NDC

National Drug Code identification number for the product.

Rx Only

Federal legend 'Rx Only' indicating prescription-only status.

Over-the-counter labeling

Labeling for products available without a prescription with required drug facts.

Dietary supplement labeling

Labeling for products intended to supplement the diet.

Storage

Conditions for storage (freezer, refrigerator, cool room temperature) as indicated.

Expiration date

Date after which product should not be used.

Reconstitution

Process to prepare a solution from a powder or concentrate.