Kuis onine ini merupakan kuis berdasarkan seminar PIC/S yang saya ikuti bulan Oktober, untuk menjawab dapat membaca artikel :
Mengikuti Seminar PIC/S GMP Guide – Seri Keempat 6 Oktober 2016 (bagian 1)
dan
Mengikuti Seminar PIC/S GMP Guide – Seri Keempat 6 Oktober 2016 (bagian 2)
berikut soal-soal kuisnya, selamat mengikuti:
Kuis PICS Contract Manufacturer
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Fithrul
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Question 1 of 25
1. Question
The contract must clearly state the way in which the authorised person releasing each batch of product for sale exercises his full responsibility
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Question 2 of 25
2. Question
All arrangements for contract manufacture and analysis including any proposed changes in technical or other arrangements should have more priority than the marketing authorization
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Question 3 of 25
3. Question
The Contract Giver is responsible for assessing the competence of the Contract Acceptor to carry out successfully the work required
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Question 4 of 25
4. Question
The Contract Giver does not need to ensure that the Contract Acceptor is fully aware of any problems associated with the product, if Acceptor following described matter in contract.
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Question 5 of 25
5. Question
The Contract Giver should ensure that all processed products and materials delivered to him by the Contract Acceptor comply with their specifications or that the products have been released by an authorised person.
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Question 6 of 25
6. Question
Contract manufacture can be undertaken only by a manufacturer who is approved by Contract Giver.
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Question 7 of 25
7. Question
The Contract Acceptor should refrain from any activity which may adversely affect the quality of the product manufactured and/or analysed for the Contract Giver.
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Question 8 of 25
8. Question
A contract should be drawn up by the Contract Giver only, which specifies their respective responsibilities relating to the manufacture and control of the product
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Question 9 of 25
9. Question
The contract should specify the way in which the authorised person releasing the batch for sale ensures that each batch has been manufactured and checked for compliance with the requirements of Marketing Authorisation
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Question 10 of 25
10. Question
The contract should describe clearly Contract Accepter is responsible for purchasing materials, testing and releasing materials, undertaking production and quality controls, including in process controls, and Contract Accepter has responsibility for sampling and analysis
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Question 11 of 25
11. Question
Even in case of contract analysis, the Contract Giver should understand that he is subject to inspection by the competent Authorities
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Question 12 of 25
12. Question
All complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures
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Question 13 of 25
13. Question
A person should be designated responsible for handling the complaints and deciding the measures to be taken together with sufficient supporting staff to assist him
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Question 14 of 25
14. Question
Any complaint concerning a product defect should be recorded with all the original details and thoroughly investigated. The person responsible for Quality Control should normally be involved in the study of such problems
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Question 15 of 25
15. Question
All the decisions and measures taken as a result of a complaint should be recorded and referenced to the corresponding batch records
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Question 16 of 25
16. Question
Special attention should be given to establishing whether a complaint was caused because of counterfeiting
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Question 17 of 25
17. Question
Recall operations should be done after organize project team promptly
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Question 18 of 25
18. Question
Self-inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures
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Question 19 of 25
19. Question
Self-inspections should be conducted in an independent and detailed way by designated competent person(s) from the company. Independent audits by external experts must not be used.
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Question 20 of 25
20. Question
All self-inspections should be recorded. Reports should contain all the observations made during the inspections and, where applicable, proposals for corrective measures. Statements on the actions subsequently taken should also be recorded
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Question 21 of 25
21. Question
When submitted to a regulatory authority, the Site Master File should provide information as detailed as possible in order that inspector(s) can fully understand the manufacturer’s GMP related activities.
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Question 22 of 25
22. Question
The Site Master File (SMF) should have an edition number. Each Appendix of SMF can have an individual effective date, independent from revision of the main text of SMF.
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Question 23 of 25
23. Question
The Site Master File should include information about size and layout of the site, e.g. simple plans of manufacturing areas with indication of scale, but detailed engineering drawings are not required
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Question 24 of 25
24. Question
Product list in Site Master File should include sales name and strength of each product
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Question 25 of 25
25. Question
Regarding to product distribution, Site Master File should include information on measures to maintain product traceability and to prevent the products to fall in the illegal supply chain.
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Leaderboard: Kuis PICS Contract Manufacturer
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M. Fithrul Mubarok
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