Contrôle De Qualité II Test

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

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

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?

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 is the reason for initiating a CAPA?

Quality Assurance involved in pharmaceutical manufacturing process from?

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

The entry in Batch Manufacturing Record is done by?

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

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

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

What does the abbreviation GMP stand for in the context 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?

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

The following statements are true, except?

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?

What is QA?

Receiving of wet Products is complaint associated with?

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

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

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

Choose the correct sentence?

Two general techniques for antibiotics microbial assay are?

Définition de la spécification ?

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

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

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

Responsibility of a complaint lies with?

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?

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

The correct sequence for handling complaint is?

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

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

Quality Control involved in pharmaceutical manufacturing process from?

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

A Preventive Action is put in place to?

The principle of laboratory results-out of specification is?

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

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

The main objective of quality assurance is?

La bonne pratique de fabrication (BPF) est appliquée ?

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?

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?

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

The procedures of quality control laboratory are included, except?

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

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

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

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

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

Which phrase is described about deviation report system?

Issues related to foreign matter in a product is?

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

OOS is abbreviation used for?