Contrôle De Qualité II Test

18-Which of following statement(s) is/are about quality assurance (A. QA is a set of activities for ensuring quality in the processes by which products are developed. / B. QA is a corrective action and product oriented.)?

The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or on to a starting material or intermediate product is?

In process control (Contrôle en cours de la fabrication) ធ្វើដើម្បី?

The following statements are true, except?

All documents associated with the manufacture of a batch of bulk product or finished product that provide a history of each batch of product is?

Bulk/ finished product when retrieval or withdrawal from market is known as?

Which of the following is an example of QA?

Bulk/ finished product when sent back to Manufacturer, distributor, importer is known as?

Primary document to be reviewed in technical investigation stage of complaint handling is?

When there is probability by a product to cause serious health issues, it is?

Any deviation occur can reported by?

The finished products containing active ingredients should comply with ………………. composition of the marketing authorization.?

What is the purpose of conducting process validation in pharmaceutical manufacturing?

An audit performed by an organization on itself is called a?

The correct sequence for handling complaint is?

An enclosed space with two or more doors, which is interposed between two or more rooms for the purpose of controlling the airflow between those rooms when they need to be entered, is?

Which type of validation is conducted when changes are made to an existing validation process or equipment?

What is the purpose of analytical method validation in the pharmaceutical industry?

The principle of laboratory results-out of specification is?

Serious adverse reactions of product that cause serious consequences to health after receipt of complaint must be recall within?

What is the purpose of conducting internal audits in a pharmaceutical plant?

What is the reason for initiating a CAPA?

The procedures of quality control laboratory are included, except?

Withdrawing or removing the product from distribution network as of quality issues/ adverse drug reactions is known as?

La Module 3 du dossier CTD (ou ACTD) est décrit des informations concernent ?

An area with defined environmental control of particulate and microbial contamination, is?

Following this statement are general objectives of quality assurance, except?

Which of the following options is correct regarding Production and QC?

Which of the following is NOT covered under Finished product quality assurance?

A Preventive Action is put in place to?

Which QMS tool is used to track and analyze customer complaints and feedback?

The activity (potency) of antibiotics can be demonstrated by their inhibitory effect on microorganisms. The method can be used for analysis is?

What is QA?

Which of the following department holds responsibilities for quality monitoring or audit?

The entry in Batch Manufacturing Record is done by?

If a complaint is received from customers, doctors, paramedics, clinics, hospitals, drugstores etc. the source of complaint is said to be?

Complaints arising because of not keeping products under appropriate conditions of temperature, humidity and light so that the identity, strength, quality and purity of the drug product are affected are called as?

The assay depends on the inhibition of growth of a microorganism in a uniform solution of the antibiotic in a fluid medium is the principle of?

Evaluating the Root Cause of a nonconformance happens in which stage of a CAPA?

When only complaint sample is OOS, with no definite reason, like packaging material is different etc. it is referred as?

Contamination of a starting material, intermediate product or finished product with another starting material or product during production is?

Quality Assurance involved in pharmaceutical manufacturing process from?

Issues related to labeling or coding of batch details, secondary packaging material problems comes under the complaint?

Responsibility of a complaint lies with?

Quality Control involved in pharmaceutical manufacturing process from?

Which of the following is an example of an analytical testing method used in quality assurance of pharmaceutical products?

The procedures of quality control laboratory are included, except?

Which phrase is not correct about deviation report system?

If a complaint is received by email, the source of complaint is said to be?

When complaint & retained sample are in compliance with specification, Complaint sample is OOS due to misuse/ mishandling, it is?

The procedures of quality control laboratory are included, except?

Choose incorrect sentence?

What is the main objective of quality assurance in a pharmaceutical plant?

When there is probability that Product may cause temporary or remote Adverse health issues it is?

What is the primary purpose of conducting a validation study in the pharmaceutical industry?

What does the abbreviation GMP stand for in the context of quality assurance in the pharmaceutical industry?

The sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use is the principle of?

A complete record of all raw data generated during each test, in addition to graphs, charts, and spectra from laboratory instrumentation, all properly identified to show the specific material and the batch tested is?

What is the purpose of conducting stability studies in pharmaceutical manufacturing?

Which of the following is not an essential element of a quality management system in a pharmaceutical plant?