Common terms used in API and Food Industries

In this article terms are defined which are commonly used in the API and food industries:

1. Deviation: 

Departure from an approved instructions or established standards.

[Instructions or standards are commonly specified in Standard operating procedure and Technical Instruction. Also Deviation is related to the systems not the product. ]

2. Non Conforming Products:

 A product is said to be non conform when it is not upto the desired exceptions at any stage of raw material, intermediate or finished products.

[It is thus defect of product with in the premises]

3. Returned material :

 A material is said to be returned when the material is below the acceptance criteria of the customer.  Thus the return material is generally said to be market returned products.

4. Quarantine material: 

The material for which its fate is yet to be decided. 

[For example- the raw material for which QC has taken sample and its decision is yet to come]

[A detected non conforming material for which the committee will decide whether to rework, reprocess, reject or use as such.] 

5. Rejected material : 

The material is said to be rejected at the manufacturing premises when it is either non conform or out of specs. During investigation the committee decided not to use the material i.e to reject.

6.Rework

Subjecting an intermediate or API that does not conform to standard or specifications to one or more processing steps that are different from established manufacturing process to obtain the acceptable quality intermediate or API.

7. Reprocess

Subjecting an intermediate or API that does not conform to standard or specifications to one or more processing steps that are same as the established manufacturing process to obtain the acceptable quality intermediate or API.

All the terms except Deviation are related to the product only Deviation is for systems.  

Presently most of the API and pharmaceutical prefers to follow the single procedure to resolve issues with all the above. 

 For further query please feel free to mail at quallpharmaconsultancy@gmail.com or anshuyadav.icgian@gmail.com.

AUTHOR
ANSHU YADAV