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?

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

A Preventive Action is put in place to?

OOS is abbreviation used for?

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?

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?

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

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?

Quality Assurance involved in pharmaceutical manufacturing process from?

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

Quality Control involved in pharmaceutical manufacturing process from?

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

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

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

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

Which phrase is described about deviation report system?

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

The procedures of quality control laboratory are included, except?

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

The main objective of quality assurance is?

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

Any deviation occur can reported by?

Receiving of wet Products is complaint associated with?

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

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

Choose the correct sentence?

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

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

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

Two general techniques for antibiotics microbial assay are?

What is the reason for initiating a CAPA?

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?

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

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

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

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 entry in Batch Manufacturing Record is done by?

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

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?

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

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

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

The correct sequence for handling complaint is?

Choose incorrect sentence?

Which of the following is an example of QA?

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

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

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

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

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?

The principle of laboratory results-out of specification is?

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

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

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