Contrôle De Qualité II Test

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?

Any deviation occur can reported by?

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

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

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

Any deviation occur can reported by?

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?

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

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?

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

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

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

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

What is QA?

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

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

The following statements are true, except?

The procedures of quality control laboratory are included, except?

The entry in Batch Manufacturing Record is done by?

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

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

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?

The main objective of quality assurance is?

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

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

Which of the following is an example of QA?

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?

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

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

Choose the correct sentence?

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

OOS is abbreviation used for?

A Preventive Action is put in place to?

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

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

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 phrase is not correct about deviation report system?

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

The procedures of quality control laboratory are included, except?

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

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

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

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

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?

Choose the correct sentence?

Two general techniques for antibiotics microbial assay are?

Receiving of wet Products is complaint associated with?

The procedures of quality control laboratory are included, except?

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?

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

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

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

The correct sequence for handling complaint is?

La bonne pratique de fabrication (BPF) est appliquée ?