Contrôle De Qualité II Test

The main objective of quality assurance is?

Any deviation occur can reported by?

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

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

The procedures of quality control laboratory are included, except?

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

Choose incorrect sentence?

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

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

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

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

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?

The correct sequence for handling complaint is?

Which of the following is an example of QA?

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

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?

Responsibility of a complaint lies with?

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

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

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

The procedures of quality control laboratory are included, except?

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

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

Two general techniques for antibiotics microbial assay are?

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

Choose the correct sentence?

The assay depends on diffusion of the antibiotic from a vertical through a solidified agar layer in a Petri dish is the principle of?

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?

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

Définition de la spécification ?

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

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

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

Receiving of wet Products is complaint associated with?

Any deviation occur can reported by?

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

The following statements are true, except?

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

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

The entry in Batch Manufacturing Record is done by?

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

Which phrase is not correct about deviation report system?

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

What is QA?

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 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?

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

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

The procedures of quality control laboratory are included, except?

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

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?

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?

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

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

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

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?