Contrôle De Qualité II Test

Choose incorrect sentence?

The correct sequence for handling complaint is?

The main objective of quality assurance 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?

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

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

Which of the following is an example of QA?

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?

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?

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

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

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

The procedures of quality control laboratory are included, except?

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

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

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?

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

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

Définition de la spécification ?

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

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

Two general techniques for antibiotics microbial assay are?

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

Issues related to foreign matter in a product is?

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?

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?

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

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

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

A Preventive Action is put in place to?

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

La bonne pratique de fabrication (BPF) est appliquée ?

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?

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

Which phrase is described about deviation report system?

Quality Assurance involved in pharmaceutical manufacturing process from?

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

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?

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.)?

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

Quality Control involved in pharmaceutical manufacturing process from?

What is QA?

What is the reason for initiating a CAPA?

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

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

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 principle of laboratory results-out of specification is?

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

Any deviation occur can reported 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?

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

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

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

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

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

Choose the correct sentence?

The procedures of quality control laboratory are included, except?

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?