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

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

3) Quality Assurance involved in pharmaceutical manufacturing process from?

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

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

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

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

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

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

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

11) Choose the correct sentence?

12) 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?

13) 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?

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

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

16) 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?

17) Définition de la spécification ?

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

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

20) Choose the correct sentence?

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

22) 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?

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

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

25) Two general techniques for antibiotics microbial assay are?

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

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

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

29) 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?

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

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

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

33) 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?

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

35) Quality Control involved in pharmaceutical manufacturing process from?

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

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

38) Choose incorrect sentence?

39) OOS is abbreviation used for?

40) What is QA?

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

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

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

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

45) Any deviation occur can reported by?

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

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

48) A Preventive Action is put in place to?

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

50) Receiving of wet Products is complaint associated with?

51) What is the reason for initiating a CAPA?

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

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

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

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

56) Which phrase is described about deviation report system?

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

58) Responsibility of a complaint lies with?

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

60) 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?

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

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

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

64) 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?

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

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

67) Any deviation occur can reported by?

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

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

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

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

72) 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?

73) The following statements are true, except?

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

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

76) The main objective of quality assurance is?

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

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

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

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

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

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

83) 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.)?

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

85) The correct sequence for handling complaint is?

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