Contrôle De Qualité II Test

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

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

Any deviation occur can reported by?

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

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

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

A Preventive Action is put in place to?

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

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

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

Any deviation occur can reported by?

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

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

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

The main objective of quality assurance is?

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

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

Issues related to foreign matter in a product is?

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

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

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

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?

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?

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

The procedures of quality control laboratory are included, except?

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

The following statements are true, except?

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

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

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

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

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

Choose the correct sentence?

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?

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

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

A complete record of all raw data generated during each test, in addition to graphs, charts, and spectra from laboratory instrumentation, all properly identified to show the specific material and the batch tested is?

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

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

The procedures of quality control laboratory are included, except?

Responsibility of a complaint lies with?

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

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

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

What is the reason for initiating a CAPA?

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

Which of the following is an example of QA?

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?

Choose incorrect sentence?

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

Which phrase is not correct about deviation report system?

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

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

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

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

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?

Choose the correct sentence?

The correct sequence for handling complaint is?

What is QA?