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Thursday, May 30, 2024

Equipment Qualification outline in light of regulatory

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Regulatory requirements significantly influence the equipment qualification process in the pharmaceutical industry. The key regulatory bodie...
Monday, May 27, 2024

Advancements and knowledge gaps in ICH Q2(R2)

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Starting with the relationship between ICH Q14 and Q2(R2), the authors take a critical look at the new aspects incorporated in ICH Q2(R2). T...
Saturday, May 25, 2024

why two different batches key starting material can't be mixed to produce active Pharmaceutical Ingredient

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Mixing batches of starting materials to produce an active pharmaceutical ingredient (API) is generally not recommended for the following rea...

can I mix two different raw material batches activity pharmaceutical ingredient

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It is generally not recommended to mix two different raw material batches when producing an active pharmaceutical ingredient (API). Here are...
Saturday, May 18, 2024

ICH Q3C: New Version of the Guideline for Residual Solvents published

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The essence of the update is if in any manufacturing process contains only Class 3 solvents and the manufacturer measures residual solvents ...
Saturday, May 11, 2024

Understand ICH Q7 S13

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Is the lifecycle approach to process validation acceptable for APIs under ICH Q7? Yes, ICH Q7 does not preclude the lifecycle approach [ICH ...

Understand ICH Q7 S12

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When is it acceptable for an API manufacturer to extend an API retest date [ICH Q7, 11.6]?  The purpose of a retest date is to ensure that t...
Thursday, May 2, 2024

My New Artificial intelligence Assistant talking on cGMP

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Over view of Lean Management

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Lean management is a business approach focused on maximizing customer value while minimizing waste. It originated from the Toyota Production...

Lean GMP: is "right-sizing" GMP and Compliance possible?

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Good Manufacturing Practices (GMP) in the pharmaceutical industry are designed to ensure that products are consistently produced and control...