1) Choose the correct sentence?

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

3) 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?

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

5) OOS is abbreviation used for?

6) 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?

7) The correct sequence for handling complaint is?

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

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

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

11) The following statements are true, except?

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

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

14) Issues related to foreign matter in a product is?

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

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

17) Receiving of wet Products is complaint associated with?

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

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

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

21) La bonne pratique de fabrication (BPF) est appliquée ?

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

23) 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.)?

24) A Preventive Action is put in place to?

25) The procedures of quality control laboratory are included, except?

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

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

28) The entry in Batch Manufacturing Record is done by?

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

30) 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?

31) Which of the following is an example of QA?

32) Définition de la spécification ?

33) Choose incorrect sentence?

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

35) 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?

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

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

38) The main objective of quality assurance is?

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

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

41) Two general techniques for antibiotics microbial assay are?

42) The procedures of quality control laboratory are included, except?

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

44) Quality Control involved in pharmaceutical manufacturing process from?

45) Responsibility of a complaint lies with?

46) What is QA?

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

48) Which phrase is described about deviation report system?

49) 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?

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

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

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

53) The principle of laboratory results-out of specification is?

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

55) 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?

56) What is the reason for initiating a CAPA?

57) Choose the correct sentence?

58) 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?

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

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

61) Any deviation occur can reported by?

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

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

64) Quality Assurance involved in pharmaceutical manufacturing process from?

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

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

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

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

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

70) 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?

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

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

73) 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?

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

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

76) Which phrase is not correct about deviation report system?

77) The procedures of quality control laboratory are included, except?

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

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

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

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

82) Any deviation occur can reported by?

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

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

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

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