Classification of change control in Pharma

Change control can be classified as:

Minor change control

Major change control

Critical change control

Minor change control:

Any change that has minimal potential to have an adverse effect on quality, identity, strength, purity or potency of the product. They may not impact on the quality, efficacy and safety of the product it can be consider as Minor change control.

 Major change control:

 Any change that has moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product They may be indirectly or directly impact on the quality , efficacy and safety of the product it can be consider as Major change control.

Critical change control:

Any change has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a product. They may directly impact on the quality, efficacy and safety of the product it can be consider as Major change control.

Concept of Temporary change control and permanent change control are also used in Pharma Company

Temporary change control:

Any change which initiated for short period of time is considered as a temporary change control. to evaluate the change before it execute permanently temporary change Control procedure shall be followed.

Permanent change control:

Any change which will continue from on wards Permanent.

     Change can be any addition, Removal or modification in system.

Change can be done on in raw materials, specifications, analytical methods, facilities, support systems, equipment (including computer hardware), processing steps, utilities system, labelling, document and packaging materials, and computer software.

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Change control Management in Pharma