Contrôle De Qualité II Test

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

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

The entry in Batch Manufacturing Record is done by?

Which phrase is described about deviation report system?

The principle of laboratory results-out of specification is?

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

What is QA?

The procedures of quality control laboratory are included, except?

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?

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

Quality Assurance involved in pharmaceutical manufacturing process from?

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

Définition de la spécification ?

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

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

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

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

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?

Which phrase is not correct about deviation report system?

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

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?

A Preventive Action is put in place to?

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.)?

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

Quality Control involved in pharmaceutical manufacturing process from?

Responsibility of a complaint lies with?

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

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

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

Choose the correct sentence?

Following this statement are general objectives of quality assurance, 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?

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

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

Receiving of wet Products is complaint associated with?

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 correct sequence for handling complaint is?

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

What is the reason for initiating a CAPA?

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

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

Choose the correct sentence?

The procedures of quality control laboratory are included, except?

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

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

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

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

Issues related to foreign matter in a product is?

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

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

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 main objective of quality assurance is?

La bonne pratique de fabrication (BPF) est appliquée ?

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

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

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

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?

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

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