Quality Assurance (QA) Quiz No.2

Created on By Pharmaceutical Guidanace

Quality Assurance (QA) Quiz

Quality Assurance (QA) is a systematic and comprehensive approach to ensure that products, services, and processes meet or exceed predefined standards and customer expectations. It is an essential part of the development and production lifecycle that helps organizations deliver high-quality results and maintain customer satisfaction.

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Question 1: Mfg. & Exp. The date shall be printed/Coded on items i.e. Cartons, foil, etc. as per product registration and countries-specific format requirement.

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Question 2 : Expiry of batch shall depend upon -

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Question 3: Do products with more than 1 API have the expiry date of the API having the shortest shelf life?

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Question 4 : Who shall be responsible for assigning the Manufacturing and expiry date of the product?

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Question 5: The manufacturing date of the batch/Lot shall be the month in which the Raw materials are dispensed.

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Question 6: Who shall assign the batch number to the BMR?

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Question 7: Officer/Executive QA shall be responsible for the issuance of BMRs.

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Question 8: Expiry Date:- The expiry date shall be the date during which the product is supposed to be within its approved specifications.

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Question 9: If a change control is pending for approval after predefined defined timeline from the date of login, it is the discretion of the Head QA or designee to approve or reject the change control.

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Question 10: Who will be responsible for the final approval of the change control?

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Question 11: Who shall raise the change control?

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Question 12: Any change in the documents shall be governed by the Change control procedure?

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Question 13: Which department shall prepare the approved vendor list?

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Question 14: Who shall be responsible for procuring Raw/Packaging Material from the Vendor?

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Question 15: Who shall be responsible for conducting vendor audits?

Your score is

The average score is 74%



About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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