Contrôle De Qualité II Test

Choose the correct sentence?

A Preventive Action is put in place to?

What is the reason for initiating 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?

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

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

The procedures of quality control laboratory are included, except?

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?

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

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?

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 procedures of quality control laboratory are included, except?

Issues related to foreign matter in a product is?

The main objective of quality assurance is?

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

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

Choose incorrect sentence?

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

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

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

Which phrase is not correct about deviation report system?

The correct sequence for handling complaint is?

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

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

Choose the correct sentence?

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?

The following statements are true, except?

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?

OOS is abbreviation used for?

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

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

Which phrase is described about deviation report system?

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

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

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

Receiving of wet Products is complaint associated with?

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

The procedures of quality control laboratory are included, except?

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

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

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?

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

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

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.)?

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

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

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

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

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?

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

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

What is QA?

The entry in Batch Manufacturing Record is done by?

Quality Assurance involved in pharmaceutical manufacturing process from?

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

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

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

Two general techniques for antibiotics microbial assay are?

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