Contrôle De Qualité II Test

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

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

Choose incorrect sentence?

Quality Control involved in pharmaceutical manufacturing process from?

Définition de la spécification ?

The following statements are true, except?

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

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?

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

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

Receiving of wet Products is complaint associated with?

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

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

What is the reason for initiating a CAPA?

La bonne pratique de fabrication (BPF) est appliquée ?

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?

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?

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

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

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

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

Any deviation occur can reported by?

The principle of laboratory results-out of specification is?

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

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 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?

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?

Which of the following is not an essential element of 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?

Two general techniques for antibiotics microbial assay are?

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

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

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

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

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

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

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

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

Responsibility of a complaint lies with?

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

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

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

A Preventive Action is put in place to?

Choose the correct sentence?

The entry in Batch Manufacturing Record is done by?

OOS is abbreviation used for?

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

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 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?

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

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

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

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