Produksi dan QC merupakan bagian penting dalam industri farmasi, pemahaman mengenai prinsip-prinsip CPOB merupakan keharusan. Untuk menjawab kuis, anda dapat membaca artikel saya sebelumnya:
Mengikuti Seminar PIC/S GMP Guide – Seri Ketiga 11 Agustus 2016
Berikut Kuisnya:
QUIZ PIC/S PRODUCTION AND QUALITY CONTROL
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KUIS TENTANG PICS SERI KE 3 PRODUKSI DAN QUALITY CONTROL
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TERIMA KASIH TELAH MENGIKUTI KUIS INI
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Question 1 of 25
1. Question
All incoming materials should be checked to ensure that the consignment corresponds to the order.
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Question 2 of 25
2. Question
Damage to containers is not GMP target due to not categorized as material. Therefore, only storage control is applied
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Question 3 of 25
3. Question
Intermediate and bulk products purchased as such should not be handled on receipt as though they were starting materials.
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Question 4 of 25
4. Question
At the critical process, products and materials should be protected from microbial and other contamination
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Question 5 of 25
5. Question
If the labels applied to containers, equipment or premises is clear, it’s not necessary to use the specific format
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Question 6 of 25
6. Question
If a deviation from instructions and procedures occur, it should be discarded even has been approved by competent person
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Question 7 of 25
7. Question
Access to production premises should be restricted to authorized personnel
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Question 8 of 25
8. Question
Normally, the production of medicinal products is not allowed in areas and with the equipment destine for the non-medicinal products. However, the production of non-medicinal products in areas and with the equipment destine for the medicinal products is accepted
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Question 9 of 25
9. Question
Providing appropriate air locks and air extraction is one of the appropriate technical measures to avoid cross contamination
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Question 10 of 25
10. Question
Using “open systems” of production is one of the appropriate technical measures to avoid cross contamination
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Question 11 of 25
11. Question
Any minor amendments to the manufacturing process, including any changes in equipment or materials, which may affect product quality and/or the reproducibility of the process should be validated
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Question 12 of 25
12. Question
Processes and procedures should undergo periodic critical revalidation to ensure that they remain capable of achieving the intended results.
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Question 13 of 25
13. Question
The purchase of starting materials is an important operation which should involve only QA staff who have a particular and thorough knowledge of the suppliers
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Question 14 of 25
14. Question
Starting materials should only be purchased from approved suppliers named in the relevant specification
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Question 15 of 25
15. Question
The deviation less than the expected yield should be recorded and investigated
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Question 16 of 25
16. Question
The purchase, handling, and control of all packaging materials, not limited to primary and printed packaging materials, should also be accorded attention similar to that given to starting materials
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Question 17 of 25
17. Question
Each delivery or batch of all materials should be given a specific reference number or identification mark
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Question 18 of 25
18. Question
The line-clearance can be performed to the items that are not being described on the check list
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Question 19 of 25
19. Question
The name and batch number of the product being handled should be displayed at each packaging station or line
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Question 20 of 25
20. Question
Samples taken away from the packaging line should not be returned.
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Question 21 of 25
21. Question
The reprocessing of rejected products should be exceptional.
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Question 22 of 25
22. Question
Finished product assessment is only compatible with finished product specification
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Question 23 of 25
23. Question
Any quality control documentation relating to a batch record should be retained for one year after the expiry date of the batch
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Question 24 of 25
24. Question
Validation for analytical methods of pharmacopoeia listing is not required.
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Question 25 of 25
25. Question
Laboratory reagents intended for prolonged use should be marked with the preparation date and the signature of the person who prepared them. The expiry date of unstable reagents and culture media should be indicated on the label, together with specific storage conditions.
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