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

2) 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?

3) 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.)?

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

5) The main objective of quality assurance is?

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

7) A Preventive Action is put in place to?

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

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

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

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

12) Quality Assurance involved in pharmaceutical manufacturing process from?

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

14) Choose the correct sentence?

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

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

17) The correct sequence for handling complaint is?

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

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

20) Any deviation occur can reported by?

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

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

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

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

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

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

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

28) 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?

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

30) 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?

31) Définition de la spécification ?

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

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

34) What is QA?

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

36) Quality Control involved in pharmaceutical manufacturing process from?

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

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

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

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

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

42) 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?

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

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

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

46) Responsibility of a complaint lies with?

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

48) Which phrase is described about deviation report system?

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

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

51) 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?

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

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

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

55) OOS is abbreviation used for?

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

57) 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?

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

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

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

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

62) Choose the correct sentence?

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

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

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

66) Two general techniques for antibiotics microbial assay are?

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

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

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

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

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

72) Any deviation occur can reported by?

73) 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?

74) Receiving of wet Products is complaint associated with?

75) 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?

76) Choose incorrect sentence?

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

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

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

80) What is the reason for initiating a CAPA?

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

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

83) 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?

84) The following statements are true, except?

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

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