Contrôle De Qualité II Test

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

Définition de la spécification ?

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

Any deviation occur can reported by?

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

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?

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

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

The following statements are true, except?

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

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

What is the reason for initiating a CAPA?

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

Receiving of wet Products is complaint associated with?

Choose the correct sentence?

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

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

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

Choose incorrect sentence?

A Preventive Action is put in place to?

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?

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

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

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

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

The laboratory results-out of specification (OOS) is reported by?

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

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

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

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

What is QA?

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

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

The correct sequence for handling complaint is?

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?

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

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

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?

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?

Choose the correct sentence?

The procedures of quality control laboratory are included, except?

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

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

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

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

Quality Control involved in pharmaceutical manufacturing process from?

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

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

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

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

Which phrase is described about deviation report system?

The entry in Batch Manufacturing Record is done by?

The main objective of quality assurance is?

The procedures of quality control laboratory are included, except?

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

Any deviation occur can reported by?

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

Issues related to foreign matter in a product is?