1) 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?

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

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

4) 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?

5) OOS is abbreviation used for?

6) 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?

7) Any deviation occur can reported by?

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

9) 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?

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

11) Receiving of wet Products is complaint associated with?

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

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

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

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

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

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

18) 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?

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

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

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

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

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

24) Choose the correct sentence?

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

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

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

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

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

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

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

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

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

34) Responsibility of a complaint lies with?

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

36) What is QA?

37) What is the reason for initiating a CAPA?

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

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

40) The following statements are true, except?

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

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

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

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

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

46) A Preventive Action is put in place to?

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

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

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

50) 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?

51) The correct sequence for handling complaint is?

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

53) 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.)?

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

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

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

57) 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?

58) Which phrase is described about deviation report system?

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

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

61) 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?

62) Any deviation occur can reported by?

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

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

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

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

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

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

69) 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?

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

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

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

73) Quality Assurance involved in pharmaceutical manufacturing process from?

74) Choose incorrect sentence?

75) Quality Control involved in pharmaceutical manufacturing process from?

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

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

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

79) The main objective of quality assurance is?

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

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

82) Choose the correct sentence?

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

84) Two general techniques for antibiotics microbial assay are?

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

86) Définition de la spécification ?