Contrôle De Qualité II Test

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

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

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

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

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

Which one is part of quality management focused on providing confidence that quality requirement will be fulfilled?

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

La bonne pratique de fabrication (BPF) est appliquée ?

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

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

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

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?

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

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

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

Which phrase is described about deviation report system?

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

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

Responsibility of a complaint lies with?

The procedures of quality control laboratory are included, except?

The principle of laboratory results-out of specification is?

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?

What is QA?

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

The main objective of quality assurance is?

Choose the correct sentence?

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

Any deviation occur can reported by?

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

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

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

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

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?

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.)?

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

Issues related to foreign matter in a product is?

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

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

The following statements are true, except?

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

Two general techniques for antibiotics microbial assay are?

Définition de la spécification ?

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

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?

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

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

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

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

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

The procedures of quality control laboratory are included, except?

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

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

OOS is abbreviation used for?

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

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

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

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

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?