Contrôle De Qualité II Test

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

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?

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

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?

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

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

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

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

What is the reason for initiating a CAPA?

Issues related to foreign matter in a product is?

Any deviation occur can reported by?

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

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

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

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

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

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

Choose the correct sentence?

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

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

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

If a complaint is received from Production, Quality Control, Warehouse, Sales Department, the source is said to be?

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

The following statements are true, except?

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

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

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?

Choose the correct sentence?

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

Which of the following is an example of QA?

Which phrase is described about deviation report system?

The procedures of quality control laboratory are included, except?

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

Product may cause temporary or remote adverse health issues after receipt of complaint must be recall within?

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.)?

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

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

Two general techniques for antibiotics microbial assay are?

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

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

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

The entry in Batch Manufacturing Record is done by?

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

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

The main objective of quality assurance is?

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

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

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

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

What is QA?

Which phrase is not correct about deviation report system?

A document that does exactly that it summarizes all the tests performed on a product and details the results with the specifications and analytical methods for laboratory analyses with signed is?

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

The principle of laboratory results-out of specification is?

The correct sequence for handling complaint is?

The procedures of quality control laboratory are included, except?

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

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

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?