Contrôle De Qualité II Test

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?

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?

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

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

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

Issues related to foreign matter in a product is?

Choose the correct sentence?

When there is probability by a product to cause serious 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 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?

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

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 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?

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 procedures of quality control laboratory are included, except?

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?

The following statements are true, except?

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

Which phrase is not correct about deviation report system?

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?

The procedures of quality control laboratory are included, except?

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

A Preventive Action is put in place to?

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?

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

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

Any deviation occur can reported by?

What is the reason for initiating a CAPA?

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

OOS is abbreviation used for?

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

The correct sequence for handling complaint is?

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

Quality Assurance involved in pharmaceutical manufacturing process from?

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

What is QA?

Définition de la spécification ?

The entry in Batch Manufacturing Record is done by?

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?

La bonne pratique de fabrication (BPF) est appliquée ?

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?

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

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

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 of the following is an example of QA?

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

Choose the correct sentence?

Two general techniques for antibiotics microbial assay are?

The principle of laboratory results-out of specification is?

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

Quality Control involved in pharmaceutical manufacturing process from?

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

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

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