Contrôle De Qualité II Test

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?

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

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

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

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

Which of the following is an example of QA?

Which phrase is described about deviation report system?

Quality Assurance involved in pharmaceutical manufacturing process from?

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

Two general techniques for antibiotics microbial assay are?

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?

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

The principle of laboratory results-out of specification is?

Any deviation occur can reported by?

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

Responsibility of a complaint lies with?

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

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

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

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

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

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?

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.)?

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

Définition de la spécification ?

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

La bonne pratique de fabrication (BPF) est appliquée ?

The procedures of quality control laboratory are included, except?

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

What is the reason for initiating a CAPA?

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

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

What is QA?

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?

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?

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?

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

The procedures of quality control laboratory are included, except?

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

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

OOS is abbreviation used for?

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

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

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

The following statements are true, except?

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

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

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

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

The procedures of quality control laboratory are included, except?

Receiving of wet Products is complaint associated with?

A Preventive Action is put in place to?

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

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

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

Choose incorrect sentence?

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?

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?