Pharma Change Control (Change Management System)

Pharma Change Control

Change control is a systematically Approach to prevent unwanted, unapproved, and unintentional changes to validated processes, procedures, methods, equipment, documents, and facilities. This procedure is applicable to changes/deletion made to existing or introduction of new document/manufacturing process / formula / method / facility / equipment / instrument / utilities / layout / software (used in GMP aspects).The change proposals are subjected to existing or introduction of the new process, product, statutory / regulatory / customer requirements

o   Type of Change:

§  Temporary Change Control: 

    Changes for a specified limited duration where the change will be approved prior to the change being implemented with the intention of returning the system to its previous state. Temporary changes are for a certain time or for a specified number of batches. Evaluation of impact shall be the same as for permanent changes since the change could have a potential adverse impact even if only a single batch is produced under the temporary change conditions

   Note: Maximum time duration shall not be more than 120 days in case of Temporary Change.

§  Permanent Change Control:

     Changes for permanent basis or intended to permanent to the system. Specified. The changes shall be assessed for risk and taken approval before the implementation state.

·   Changes which have been assessed under a temporary change and found to be delivering the desired improvement in Practices / Procedures / Systems / Quality and can be introduced into the Practices / Procedures / Systems / Quality on a permanent basis.

·   Note: Introduction of new product/brand in the facility shall be treated as permanent.

Other things Permanent Change Control classified in sub-category

Ø  Minor change

v  A change that does not have any impact on the quality of the product and operating system.

v  Does not alter the process, significantly.

v  Has no impact on regulatory filings.

Ø  Major change

v  A change that has significant impact on the quality and/or safety of the final product.

v  Could shift the process significantly, affecting the quality yield, stability, impurity profile, etc.

v  Additional / changed testing required and suitable revalidation study to justify the change.