CGMP

Current

Dynamic

Current Good Manufacturing Practice

• System ensuring  products produced and controlled according to quality standards

• strongest impact to industry.

• GMP is not the sole responsibility of QC, but also of the production group

• tool which to refine compliance and performance

Safe

unable to cause damage

Pure

free from contamination

effective

producing the desired effect

Manufacturer

proactive steps to ensure that their products are safe, pure, and effective.

Regulatory Affairs

recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling

Quality Control

authority and responsibility

Drug Product Labels

Includes not only labels placed on immediate container but also information on the packaging, package inserts, company literatures, advertising and promotional materials.

Expiration Drug

To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use

Tamper-Evident Packaging

• To improve their security and to assure their safety and effectiveness

• “one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred”

Film wrapper

Sealed around product and or product container; film must be cut or torn to remove product.

Blister/strip pack

Individually sealed dose units; removal requires tearing or breaking individual compartments.

Bubble Pack

Product and container sealed in plastic, usually mounted om display card; plastic must be cut or broken open to remove product.

Shrink seal, band

Band or wrapper shrunk by heat or drying to conform to cap; must be torn to open package

Bottle Seal

Paper or foil sealed to mouth of container under cap

Tape Seal

Paper or foil sealed over carton flap or bottle cap

Breakable Cap

Plastic or Metal tearaway cap over container

Sealed tube

Seal over mouth or tube; must be punctured to reach the product

Sealed Carton

Carton flaps sealed; carbon cannot be opened without damage

Aerosol Container

Tamper-resistant by design

Holding and Distribution

• Written procedures must be established and followed for holding and distribution of product

• Finished pharmaceuticals must be quarantined in storage

• Products must be stored and shipped under conditions.

Laboratory Controls

• These are requirements for the establishment of and conformance to written specifications, standards, sampling plans, test procedures and other mechanisms.

• Stability testing

• Reserved samples are maintained for 1 – 3 years after expiration date of the last lot of the drug product.

Records and Reports

• Production, control and distribution records ( maintained at least 1 year after expiration date)

• Complete master production and control records for each

Information Technology and Automation

• Effective deployment of information technologies and automated systems can enhance pharmaceutical process development, production efficiencies, product quality, and regulatory compliance

• Computers, Robotic devices

Biologics

Some specific mandates for blood, bacterial, and viral products

Medical Devices

• Approval follows path similar to pharmaceuticals

• are subject to the reporting of adverse events, to recall, and to termination of approval

• Intraocular lenses, hearing aids, intrauterine devices, cardiac pacemakers, catheters, bypass machines, dental x-ray equipment, surgical gloves, prosthetic hip joints, powered wheelchairs

Container

that which holds the article

Immediate Container

that which is in direct contact with the article at all times

Closure

a part of the container

Well- Closed Container

protects the contents from extraneous solids and from loss of the article under the ordinary or customary conditions of handling, shipment, storage and distribution.

Tight Container

Protects the contents from contamination by extraneous liquids, solids, or vapors, from loss of the article, and from efflorescence, deliquescence or evaporation under the ordinary or customary conditions of handling, shipment, storage and distribution, and is capable of tight re-closure.

Light- Resistant Container

• Protects the contents from the effects of light.

• a clear and colorless or a translucent container may be made light-resistant by means of an opaque covering,.

• 290-450nm wavelength acceptable limits of light transmission

Tamper-Resistant Containers

Containers that are so sealed that the contents cannot be used without obvious destruction of the seal

Hermetic Container

impervious to air or any other gas under ordinary conditions

Multidose 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.

• These containers are commonly called vials.

Single-dose Container

• Holds a quantity of drug intended as a single dose, cannot be resealed when open

• These containers include fusion-sealed ampuls and prefilled syringes and cartridges.

Multiple Unit Dose Packaging

containers contain more than a single unit or dose of the medication

Plastics

• lightness of weight and resistance to impact,

• versatility in container design and consumer acceptance

• Consumer preference for plastic squeeze bottles

• The popularity of blister packaging and unit-dose dispensing

Polyethylene

• Widely used

• Good water barrier

• Poor oxygen barrier

• Not too clear

• Odors, flavors, gases permeate

Polypropylene

• Very popular

• Excellent barrier to water, gases

• Not too clear

Polyvinyl Chloride

• Clear, rigid

• Good oxygen barrier

• Permeable to water

• Yellows when exposed to heat or UV light

• Used for parenteral solutions

Polystyrene

• Rigid

• Crystal clear

• Used for solid dosage forms

Polycarbonate

• Clear, transparent

• Rigid

• Possible replacement for glass

• Expensive

Type I

Highly resistant borosilicate glass

Type II

Treated soda lime glass

Type III

Soda Lime Glass

Type IV/NP

General Purpose Soda Lime Glass