Contrôle De Qualité II Test

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

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

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

What is the reason for initiating a CAPA?

A Preventive Action is put in place to?

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

Any deviation occur can reported by?

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

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

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?

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

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

Which of following is a key principle of quality assurance 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?

The procedures of quality control laboratory are included, except?

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

Any deviation occur can reported by?

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?

Which of the following is an example of QA?

Choose the correct sentence?

The entry in Batch Manufacturing Record is done by?

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

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

Two general techniques for antibiotics microbial assay are?

Définition de la spécification ?

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

Issues related to foreign matter in a product is?

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

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

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

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

Which phrase is not correct about deviation report system?

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

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

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

Which phrase is described about deviation report system?

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

Quality Control involved in pharmaceutical manufacturing process from?

Choose incorrect sentence?

The following statements are true, except?

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 correct sequence for handling complaint is?

Choose the correct sentence?

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

The procedures of quality control laboratory are included, except?

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?

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

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

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?

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

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

Receiving of wet Products is complaint associated with?

The procedures of quality control laboratory are included, except?

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

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?

The main objective of quality assurance is?

The principle of laboratory results-out of specification is?

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