Manufacturing Active Pharmaceutical Ingredients
Background:
A Pharmaceutical company manufacturing Active Pharmaceutical Ingredients (API) has decided to expand its product range and move from 4 key API products to 6 key API products. This project will involve the introduction of 2 new API products. Manufacturing Active Pharmaceutical Ingredients
As Regulatory Affairs Specialist you have been assigned to this project, list 5 key areas you need to consider to ensure no Regulations are breached during the project. Include references to specific Regulation clauses.
Example: a)
Eudralex Vol 4
Part II – Basic Requirements for Active Substances Used as Starting Materials
5 Process Equipment 5.1 Design and Construction 5.10 Equipment used in manufacturing intermediates and APIs should be appropriate design and size and suitably located for its intended use, cleaning, sanitization (where appropriate), and maintenance.
What equipment will be needed for 2 new products? Where will it be located? Will it fit/integrate with current equipment? How will cleaning, sanitization, and maintenance be managed?
Submission Details: Submit a one-word document file in Moodle with a word count as below for each identified area by Mon 20th Nov.
- ….(200 words max)
- ….(200 words max)
- ….(200 words max)
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(4 marks for each area)
A Pharmaceutical company manufacturing Active Pharmaceutical Ingredients (API) has decided to expand its product range and move from 4 key API products to 6 key API products. This project will involve the introduction of 2 new API products.
As Regulatory Affairs Specialist you have been assigned to this project, list 5 key areas you need to consider to ensure no Regulations are breached during the project. Include references to specific Regulation clauses.
Example: a)
Eudralex Vol 4
Part II – Basic Requirements for Active Substances Used as Starting Materials
5 Process Equipment 5.1 Design and Construction 5.10 Equipment used in manufacturing intermediates and APIs should be appropriate design and size and suitably located for its intended use, cleaning, sanitization (where appropriate), and maintenance.