Contrôle De Qualité II Test

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?

La bonne pratique de fabrication (BPF) est appliquée ?

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

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

Choose incorrect sentence?

What is QA?

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?

Which of the following is an example of QA?

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

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?

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

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

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

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

Any deviation occur can reported by?

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

What is the reason for initiating a CAPA?

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

The main objective of quality assurance is?

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

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

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

Quality Assurance involved in pharmaceutical manufacturing process from?

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

Following this statement are general objectives of quality assurance, 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?

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

The procedures of quality control laboratory are included, except?

Which phrase is described about deviation report system?

Which phrase is not correct about deviation report system?

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

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

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

Choose the correct sentence?

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

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

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.)?

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

Choose the correct sentence?

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

The correct sequence for handling complaint 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?

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

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

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?

Définition de la spécification ?

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

The principle of laboratory results-out of specification is?

Issues related to foreign matter in a product is?

The following statements are true, except?

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

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?

A Preventive Action is put in place to?

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

Two general techniques for antibiotics microbial assay are?