Contrôle De Qualité II Test

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?

Choose the correct sentence?

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

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?

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

Any deviation occur can reported by?

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

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

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

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

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

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

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

Choose incorrect 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?

OOS is abbreviation used for?

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

Which of the following is an example of QA?

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

The following statements are true, except?

Définition de la spécification ?

Choose the correct sentence?

Which phrase is not correct about deviation report system?

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

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

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?

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

The procedures of quality control laboratory are included, except?

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

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

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

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 conducting internal audits in a pharmaceutical plant?

What is the reason for initiating a CAPA?

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

Responsibility of a complaint lies with?

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

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

La bonne pratique de fabrication (BPF) est appliquée ?

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

The procedures of quality control laboratory are included, except?

Two general techniques for antibiotics microbial assay are?

What is QA?

Any deviation occur can reported by?

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?

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

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

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

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

Which phrase is described about deviation report system?

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

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

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

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

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

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