UNIT 1 (POST MARKETING SURVEILLANCEㅡCURRENT GMP)

Question 1

● Continued clinical investigations that:

• may contribute to the understanding of the drug’s mechanism or scope of action
• may indicate possible new therapeutic uses for the drug
• may demonstrate the need for additional dosage strengths, dosage forms, or routes of administration

● may also reveal additional side effects, serious and unexpected adverse effects, and/ or drug interaction

Answer 1

PHASE IV

Question 2

● unintended pharmacologic effects that occur when a medication is administered correctly

Answer 2

ADVERSE DRUG REACTION

Question 3

● As defined by WHO, it is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem

Answer 3

PHARMACOLOVIGILANCE

Question 4

A ______________ can be any instrument, apparatus, implement, machine, appliance, implant reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.

Answer 4

medical device

Question 5

CLASSIFICATION OF MEDICAL DEVICES

Answer 5

● CLASS A – Low risk (e.g., bandages, adhesive bandage)

● CLASS B – Moderate Risk (contact lens, condoms with spermicide)

● CLASS C – Moderate/High Risk (condom)

● CLASS D – High Risk (e.g., implantable defibrillators, implantable pacemarkers)

Question 6

This ______ GMP guidelines is adopted to:

● Prescribe standard guidelines in the manufacture of drug products

● Ensure that no person or establishment shall manufacture drugs under substandard condition

Answer 6

1999

Question 7

● it is the system of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate for their intended use. It is thus concerned with both manufacturing and quality control processes and procedures

Answer 7

Good Manufacturing Practice (GMP)

Question 8

● the complete set of activities to produce a drug that comprise production and quality control from dispensing of materials to the release for distribution of the finished product.

Answer 8

Manufacture or Manufacturing

Question 9

● all controls measures taken designed to ensure that finished products consistently conform to establish specification of identity, strength, purity, and quality.

Answer 9

Quality Control

Question 10

● all operation starting from dispensing of materials to processing, packaging, to fished product.

Answer 10

Production

Question 11

● all substances whether active or excipients that are employed in the processing of a finished product.

Answer 11

Raw material

Question 12

● a description of starting material, intermediate, bulk or finished product in terms of its chemical, physical, and microbiological characteristics, if any. A specification shall include descriptive and or numerical clause stating standards and tolerated deviations, whenever applicable.

Answer 12

Specific of Material

Question 13

● an act of holding off a material for use, or a product for packaging or distribution by physically setting it apart or by system duly validated pending a decision an release or rejection.

Answer 13

Quarantine

Question 14

● a quantity of drug product/device that is homogenous in character and quality produced during a given cycle of manufacture and from a specific manufacturing order

Answer 14

Batch

Question 15

● a designation in number or letters or combination thereof that identifies the batch, and permits the tracing of the complete history of a batch, including all stages of its production, control and distribution

Answer 15

Batch Number

Question 16

● a batch or any portion of batch produced by a continuous process, an amount of drugs produced in a unit of time or quantity in a manner that assures its uniformity and in either case which is identified by a distinctive lot number and has uniform character and quality within specified limits

Answer 16

Lot