Contrôle De Qualité II Test

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

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?

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

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

Définition de la spécification ?

The principle of laboratory results-out of specification is?

The following statements are true, except?

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

Which of the following is an example of QA?

Responsibility of a complaint lies with?

The procedures of quality control laboratory are included, except?

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

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

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

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 main objective of quality assurance in a pharmaceutical plant?

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

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

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

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

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

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

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

Receiving of wet Products is complaint associated with?

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

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

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

A Preventive Action is put in place to?

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

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

Two general techniques for antibiotics microbial assay are?

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 entry in Batch Manufacturing Record is done by?

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?

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

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

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

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

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

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

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

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

La bonne pratique de fabrication (BPF) est appliquée ?

Quality Assurance involved in pharmaceutical manufacturing process from?

Choose incorrect sentence?

The procedures of quality control laboratory are included, except?

What is the reason for initiating a CAPA?

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

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

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

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?

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

OOS is abbreviation used for?

Any deviation occur can reported by?

The procedures of quality control laboratory are included, except?

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