Unit 4

42問 • 2年前

問題一覧

The basic document from where the master formula and batch production records are based.

Manufacturing monograph.

The document was generated to explain in detail the reason behind a procedure and proper sequence of steps to be done, and how equipment is to be operated for maximum performance.

Standard operating procedure.

The document provides the basis for accepting the quality of every component used in the manufacture of the product following the specifications and methods.

Quality control monograph.

The original document used as the key in the manufacture of products

Master formula record.

Being the prototype, it is kept in a secured documentation room, duplicated or photocopied only whenever a job order is issued.

Master formula record.

It assures identical reproduction of the product document.

Master formula record.

A batch reproduction record is an accurate reproduction of the master formula record (T/F)

True.

After being used as the guide to production actual data of what has been done are recorded therein

Batch reproduction record.

A specific amount produced in a unit of time or according to a single manufacturing order during the same cycle of manufacture

Batch.

A batch, a portion of a batch, or a combination of batches.

Lot.

The term batch number, lot number, or control number means any distinctive combination of marking, letters, or numbers by which the history of the manufacture and control of a batch or lot of a product can be determined. (T/F)

True.

Control codes should be identified as such on the label

Batch and lot number.

Differences in the format and content of batch production records from product to product are to be expected.

Batch and lot numbers.

To satisfy product identity, purity, safety, quality, and strength, products must be subjected to certain specific tests

Control test.

Individual company monographs and published compendia provide these.

Control test.

There are minimum attributes common to general categories of products. Where necessary, some of these tests are performed during processing (IPQC) of the product and repeated in the final product.

Control test.

Determines the material type, assembly, special properties, and integrity

Packaging test.

Determines the physical and chemical reactions particular for the compound, and gives the gross physical appearance

Identification test.

Determines the presence of impurities: gross, chemical, and biological.

Limit test.

Determines the conformance of dosage form when compared to label claim; this may be instrumental, chemical, or biological.

Assaying.

Tests for properties, functionalities of particular dosage forms.

Dosage form.

• During processing, the quality of the product at various stages of production is audited by quality control.

In process control.

An important requirement of GMP is that the packaging and labeling facilities are inspected before use to ensure that all drug products have been removed from previous operations and that packaging and labeling materials not suitable for subsequent operations have also been remove

Line clearance.

Reconciliation compares the amount of material going into a process with the amount coming out of the process.

Yield and reconciliation.

Focuses on losses or apparent gains of materials and is usually used for labeling and packaging operations.

Reconciliation.

focuses on acceptable product outputs and is usually needed for production processes.

Yield.

95-100%

Dry products.

95-102.5%

Liquid.

90-100%

Capsule.

85-100%

Herbal capsule.

- Fear of mix-up or sabotage - Possible pilferage by internal staff - Check for unusual wast

Out of specs.

the contamination of a starting material, intermediate product, or finished product with another starting material or product during manufacture.

Cross contamination.

Separate building for Penicillin and Non-penicillin

Cross contamination.

A clean room is an environment where the particulate contamination & bacterial contamination are limited to prescribed levels

Clean room.

Minimum particle collective efficiency of 99.97 to 99.997% for a 0.3 micron particle

High efficacy particulate air.

Minimum particle collection efficiency of 99.9997% efficient for particles greater than or equal to 0.12-micron in size

Ultra low penetration air.

A process in which the HEPA and ULPA filter is challenged by introducing dispersed particulates, in a form or aerosol, and is measured using a probe

Filter intergrity testing.

• Di-octylphthalate • PAO (Polyalphaolefin)

Filter integrity testing.

the entire body of air within a confined area moves with uniform velocity and in a single direction with generally parallel airstreams

Unidirectional.

class 100 and below have unidirectional airflow patterns.

Unidirectional.

Conventional flow clean rooms (class 1000 & 10000) have nonunidirectional or mixed airflow patterns.

non-undirectional.

airflow is not unidirectional by having a varying velocity, multiple pass circulation, or nonparallel flow direction

Non-unidirectional.

Cell structure.

Quinn Karylle Fuentes · 28問 · 2年前

Cell structure.