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31 Cards in this Set

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It should have distinguishing characteristics which will prevent possible confusion with any number previously placed on the container by the supplier

Receiving number

3 content of quality control

Inspector’s report


Analysis


Disposition

IAD

The RTR should be distributed to all groups concerned with the (3)

Purchase


Inventory


Use and control of materials

PIU

A copy of RTR is given to (4)

Quality control


Warehouse


Purchasing


Accounting

QWPA

It is prepared by the warehouse who is responsible for assigning a receiving number to the material

Receiving tally report

These are the ingredients intended for use in the manufacture of drugs and cosmetics including those that may not appear in the final product

Raw materials

The RTR is checked by a ____ for ____

QC inspector


Accuracy

Process of Reception (3)

1. RTR is checked by QC inspector for accuracy


2. Each container of raw mats. Is examined visually for damage or contamination


3. Samples are taken from a representative number of containers

RES

The ____ should not be less then ____ the amount required for one complete test

Composite sample


Three times

Process of Quarantine (3)

1. Samples are submitted to the lab for testing


2. Samples are subjected to tests


3. Disposition of samples

SSD

5 tests for samples in quarantine

Physical and organoleptic examinations


Identification tests


Limits of impurities and degradation


Assay


Microbiological tests

PILAM

The approved materials are ____ to assure that they are rotated in such a manner that the oldest stock is used first, it is known as _____

Audited


FIFO policy

On receptions of materials, a ____ is paster on the container of the material

Quarantine sticker

3 characteristics of product package

Not reactive


Not additive


Not absorptive

NNN

The 3 characteristics for packaging materials should be ____

Tested to assure integrity

Storage and handling are audited to

Prevent them from contamination and to avoid mix ups

Packaging materials which come in direct contact with the product itself

Primary packaging components

Packaging materials which do not come in direct contact with the product and serve as accessory to the primary packaging component

Secondary packing components

3 Types of Leaker’s test

Dye test


Bubble test


Vacuum ionization test

BDV

5 minimum criteria for acceptance of printed materials

Text


Color


Size


Sealability


Cleanliness

TCSSC

MIMS

Monthly Index of Medical Specialties

2 types of labels

Principal display panel


Information panel

PI

A specific situation in which a drug should not be used because it may be harmful to the person

Contraindication

A statement that indicates a possible danger or other unpleasant situation

Warning

A measure taken in advance to prevent something dangerous to happen

Precaution

Barcode

480 2826 100 348

Plastic containers for parenteral use is tested further using biological procedures for

Product sterility

It can be controlled by the mold of the packaging components

Geometry

It is assigned and is used as an identification number

Mold number

Closures should (3)

Sit on container without tilting


No leaks


Not rotate continuously

SNN

Ha

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