Distribution Control

Distribution

• defined as “the procuring, purchasing, holding, storing, selling, supplying, importing, exporting, or movement of pharmaceutical production” with the exception of the dispensing or providing pharmaceutical products directly to a patient or his/her agent

Good distribution practices

• Guidelines should be in accordance with ________

Good distribution practices

• is a quality system for pharmaceutical logistics that ensures medicinal products are stored, transported, and handled under suitable conditions from manufacturer to pharmacy or person authorized to supply to the public

Good distribution practices

• it ensures product quality, integrity, and safety throughout the supply chain

Good distribution control

• the part of quality assurance that ensures that the quality of a pharmaceutical product is maintained by meeans of adequate control of the numerous activities which occur during the distribution process as well as providing a tool to secure the distribution system from counterfeits, unapproved, illegally importated, stolen, substandard, adulterated, and/or misbranded pharmaceutical products

Good distribution practices - GDP

• Annex 5

Good storage practices - GSP

• Annex 9

Good distribution control

• it ensures the quality of medicines is maintained through strict controls during storage, transportation, and distribution

Annex 5

• Covers transport, storage, documentation, and personnel involved in distributing products

Annex 9

• Focuses on warehouse infrastructure, temperature control, and inventory management

Cold-chain management

• the management of all phases of the cold chain, including products in transit, in process, in storage, and in display

• applicable to temperature sensitive products to ensure product efficacy, safety, and adherence to relevant regulatory requirements

Reefer truck

• these trucks can handle large quantities of pharmaceutical goods and maintain exact temperature specifications, ranging from room temperature to freezing regardless of the outside temperature

-12 to -70 C

• temperature inside a reefer truck or any refrigerated vehicles

3 years

Companies should acquire respective LTOs from the FDA:

Manufacturer:

• micro and small enterprises

6 years

Companies should acquire respective LTOs from the FDA:

Manufacturer:

• Medium and large enterprises

1 year

Companies should acquire respective LTOs from the FDA:

• cosmetic establishments

2 years

Companies should acquire respective LTOs from the FDA:

• Medical device establishments

3 years

Companies should acquire respective LTOs from the FDA:

• Pharmaceutical manufacturer

3 years

Companies should acquire respective LTOs from the FDA:

• Pharmaceutical distributor, trader, wholesaler, importer, exporter

2 years

Companies should acquire respective LTOs from the FDA:

• Drug store or retail pharmacy

Stock card

• is a document that tracks the movement of inventory in a business

• it records the quantity of goods received and issued as well as the value of the inventory on hand

Dosage form

• refers to a combination of drug substances and excipients to facilitate dosing, administration, and delivery of medicine to the patient

• relates the drugs activity to its route of administration

Assay, Identification test, Water content distribution, Packaging test, Limit test

• What are the general (universal) tests of pharmaceutical products?

Physical/Mechanical testing

• evaluates structural integrity against physical stress

Drop/Impact testing

• tests resistance to falls during handling

Compression testing

• stimulates weight loads during shipping storage

Vibration testing

• tests stability during transportation

Burst/tear/puncture strength

• measures material resistance to breaking

Integrity Barrier Testing

• ensures packaging keeps products protected from the environment

Seal integrity / leak testing

• checks for leak in packaging to maintain sterility or freshness

Water absorption (cobb tests)

• measures paperboard resistance to moisture

Permeability

• tests resistance to gas or water vapor

Child-resistance testing

• assesses security of dangerous products

Compatibiltiy testing

• tests if the product reacts with its packaging

Qualitative test

• identification test, organoleptic test, physical and chemical test, limit test, packaging

Quantitative test

• limit test, assay, water content determination

Liquid dosage forms

• these are pharmaceutical formulations which contain a mixture of active drug components and nondrug components (excipients) dissolved or suspended in a suitable solvent or mixtures of solvents

Sterility test, test for pyrogens, safety test, particulate matter test, leaker’s test

Sterile/Parenterals:

Sterility test

• determination of the presence of viable organisms

Moist heat

• Bacillus stearothermophilus

Dry heat

• bacillus subtilis

Ethylene oxide

• bacillus stearothermophilus

Radiation

• B. pumilus, B. stearothermophilus, B. subtilis