New Products Equipment and Processes

The introduction of any new product, equipment, or process must proceed through ABC Pharmaceutical Company change control procedure No. QABC-001.

Before the introduction of any new product to Manufacturing or the Packaging department, an evaluation is to be made using the following criteria:

• Solubility of active materials in water

• Toxicity of the active material

• Potency of the product

In case of an active material that is already a worst-case designate, concentrations will be compared between the new products and existing products, and the product with the active material in higher concentration will be deemed the "worst case." A new cleaning validation study will be conducted if the new product has been deemed "worst case" by this investigation; otherwise, the existing cleaning validation study relevant to the particular worst-case product and equipment train will prevail.

Similarly, if a new cleaning procedure is introduced, which may impact the cleanliness of the process equipment (e.g., automated CIP procedures or new cleaning agents employed), it will undergo a new cleaning validation study for the relevant worst-case products.

New equipment addition in the production of any products that are not covered within the groupings listed in the CVMP will require a new cleaning validation study for the product deemed worst case on the relevant equipment train.

New products, processes, and equipments will be identified in subsequent revisions of

Your Company's L

Your Company's L

Your Company's N

Your Company's N

Was this article helpful?

0 0
Healthy Chemistry For Optimal Health

Healthy Chemistry For Optimal Health

Thousands Have Used Chemicals To Improve Their Medical Condition. This Book Is one Of The Most Valuable Resources In The World When It Comes To Chemicals. Not All Chemicals Are Harmful For Your Body – Find Out Those That Helps To Maintain Your Health.

Get My Free Ebook

Post a comment