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Home/Audit and Guideline/Cleaning Validation as per APIC Guideline

Cleaning Validation as per APIC Guideline

Pharmaceutical Guidanace May 19, 2020 Audit and Guideline Comments Off on Cleaning Validation as per APIC Guideline 4,037 Views

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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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Change Control

1 / 6

Question 1 : Any change in the documents shall be governed by Change control procedure?

True

False

2 / 6

Question 2: Who shall raise the change control?

Any person

Stores

Administration

QA

3 / 6

Question 3 : What role does change control play in relation to regulatory compliance?

It is optional and not related to compliance.

It helps companies evade regulatory scrutiny.

It is essential for ensuring compliance with regulatory requirements.

It is primarily a marketing tool.

4 / 6

Question 4 : What is the first step in the change control process?

Implementation

Evaluation

Planning

Closure

5 / 6

Question 5: What is the primary purpose of change control in the pharmaceutical industry?

To increase production efficiency

To reduce operating costs

To maintain and improve product quality

To expedite product development

6 / 6

Question 6 : Which regulatory requirement mandates the implementation of change control in the pharmaceutical industry?

Good Laboratory Practices (GLP)

Good Distribution Practices (GDP)

Good Manufacturing Practices (GMP)

Good Clinical Practices (GCP)

Your score is

The average score is 76%

0%

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