Contrôle De Qualité II Test

Responsibility of a complaint lies with?

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

The entry in Batch Manufacturing Record is done by?

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

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 purpose of analytical method validation in the pharmaceutical industry?

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

Choose the correct sentence?

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

Any deviation occur can reported by?

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

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?

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

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?

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

The following statements are true, except?

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?

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

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?

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

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

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

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

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

Which of the following is an example of QA?

Choose incorrect sentence?

Définition de la spécification ?

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

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

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

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

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

The principle of laboratory results-out of specification is?

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

Which phrase is not correct about deviation report system?

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 main objective of quality assurance 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?

What is the reason for initiating a CAPA?

La bonne pratique de fabrication (BPF) est appliquée ?

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

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

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

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

Which of following is a key principle of quality assurance in the pharmaceutical industry?

OOS is abbreviation used for?

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

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

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

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

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

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

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

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

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

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

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

Which phrase is described about deviation report system?

Issues related to foreign matter in a product is?