Contrôle De Qualité II Test

What is QA?

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

The entry in Batch Manufacturing Record is done by?

Quality Assurance involved in pharmaceutical manufacturing process from?

Which department is typically responsible for implementing and maintaining a quality management system in a pharmaceutical plant?

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

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

Which one is part of quality management focused on providing confidence that quality requirement will be fulfilled?

The following statements are true, except?

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?

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

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

The assay depends on diffusion of the antibiotic from a vertical through a solidified agar layer in a Petri dish is the principle of?

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

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

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?

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

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

The principle of laboratory results-out of specification is?

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

Which phrase is described about deviation report system?

Choose the correct sentence?

Choose incorrect sentence?

Which QMS tool helps in understanding the cause-and-effect relationship between various factors influencing a problem?

The main objective of quality assurance is?

Which type of validation is conducted during the initial installation of a new piece of equipment?

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

To approve or reject the starting materials, packaging materials, intermediate, bulk and finished product is the responsibility of which department?

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

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

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

What is the reason for initiating a CAPA?

Issues related to foreign matter in a product is?

Définition de la spécification ?

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

Which following is not a component of quality assurance in a pharmaceutical plant?

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

The procedures of quality control laboratory are included, except?

Which phase of process validation involves demonstrating that a process can consistently produce a desired product under normal operating conditions?

Which of the following is an example of QA?

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

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

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

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

The procedures of quality control laboratory are included, except?

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

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

The laboratory results-out of specification (OOS) is reported by?

Two general techniques for antibiotics microbial assay are?

Any deviation occur can reported by?

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

Any deviation occur can reported by?

What is the role of standard operating procedures (SOPs) in quality assurance?

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

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

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?

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

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?

Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its specifications is?

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.)?