Contrôle De Qualité II Test

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

Which phrase is described about deviation report system?

What is the reason for initiating a CAPA?

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?

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

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

Two general techniques for antibiotics microbial assay are?

The principle of laboratory results-out of specification is?

Any deviation occur can reported by?

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

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

The procedures of quality control laboratory are included, except?

Choose the correct sentence?

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

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

The procedures of quality control laboratory are included, except?

Which of the following is an example of QA?

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

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

Choose incorrect sentence?

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

Issues related to foreign matter in a product is?

Any deviation occur can reported by?

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

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

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?

Which phrase is not correct about deviation report system?

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

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

Responsibility of a complaint lies with?

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?

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

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 stability studies in pharmaceutical manufacturing?

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?

OOS is abbreviation used for?

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

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?

La bonne pratique de fabrication (BPF) est appliquée ?

What is QA?

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?

The entry in Batch Manufacturing Record is done by?

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

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

A Preventive Action is put in place to?

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?

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

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

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

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

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

The correct sequence for handling complaint is?

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

Receiving of wet Products is complaint associated with?

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

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

Définition de la spécification ?

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

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