Contrôle De Qualité II Test

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

Receiving of wet Products is complaint associated with?

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

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?

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

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

Any deviation occur can reported by?

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

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

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?

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

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?

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

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

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

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

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

The correct sequence for handling complaint is?

Choose the correct sentence?

The following statements are true, except?

The main objective of quality assurance is?

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

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

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

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?

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

La bonne pratique de fabrication (BPF) est appliquée ?

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

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?

The procedures of quality control laboratory are included, except?

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

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

The procedures of quality control laboratory are included, except?

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?

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

Responsibility of a complaint lies with?

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

A Preventive Action is put in place to?

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

Quality Assurance involved in pharmaceutical manufacturing process from?

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?

Which phrase is described about deviation report system?

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

Quality Control involved in pharmaceutical manufacturing process from?

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

What is the reason for initiating a CAPA?

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

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

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

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

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.)?

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

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

Which phrase is not correct about deviation report system?

OOS is abbreviation used for?

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

Any deviation occur can reported by?