Contrôle De Qualité II Test

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

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

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

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

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

The following statements are true, except?

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

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?

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

What is the reason for initiating a CAPA?

Quality Control involved in pharmaceutical manufacturing process from?

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

A Preventive Action is put in place to?

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

Any deviation occur can reported by?

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?

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

What is QA?

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

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

Which phrase is described about deviation report system?

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

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

The main objective of quality assurance 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?

The entry in Batch Manufacturing Record is done by?

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

Choose the correct sentence?

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 the following is an example of QA?

Responsibility of a complaint lies with?

Issues related to foreign matter in a product is?

The procedures of quality control laboratory are included, except?

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

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 of the following options is correct regarding Production and QC?

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

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

What is the primary purpose of conducting a validation study 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?

Quality Assurance involved in pharmaceutical manufacturing process from?

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

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

The principle of laboratory results-out of specification is?

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

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

Two general techniques for antibiotics microbial assay are?

The procedures of quality control laboratory are included, except?

Any deviation occur can reported by?

La bonne pratique de fabrication (BPF) est appliquée ?

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

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

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

Choose incorrect sentence?

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

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 department holds responsibilities for quality monitoring or audit?