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?

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

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

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

Which of the following is an example of QA?

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

What is the reason for initiating a CAPA?

Issues related to foreign matter in a product is?

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

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

Choose incorrect sentence?

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

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

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

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

Quality Control involved in pharmaceutical manufacturing process from?

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?

Quality Assurance involved in pharmaceutical manufacturing process from?

Responsibility of a complaint lies with?

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

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?

What is QA?

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

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?

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

Choose the correct sentence?

The entry in Batch Manufacturing Record is done by?

The main objective of quality assurance is?

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

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

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

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

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

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

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?

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

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

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

Any deviation occur can reported by?

A Preventive Action is put in place to?

The correct sequence for handling complaint is?

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

The following statements are true, except?

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

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 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?

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?

The principle of laboratory results-out of specification 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?

OOS is abbreviation used for?

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

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

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

Choose the correct sentence?

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?

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?