Contrôle De Qualité II Test

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

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

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

The following statements are true, except?

Choose the correct sentence?

What is the reason for initiating a CAPA?

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

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

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

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

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

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

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

Receiving of wet Products is complaint associated with?

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.)?

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

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

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

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

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

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

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

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

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

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

Responsibility of a complaint lies with?

Définition de la spécification ?

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

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

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

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

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

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

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

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

What is QA?

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

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

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

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

The main objective of quality assurance is?

Any deviation occur can reported by?

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?

Which phrase is not correct about deviation report system?

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

Issues related to foreign matter in a product is?

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

Two general techniques for antibiotics microbial assay are?

The entry in Batch Manufacturing Record is done by?

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

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

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

The procedures of quality control laboratory are included, except?

The procedures of quality control laboratory are included, except?

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

Which phrase is described about deviation report system?

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