In the last decade it has been seen & realised how important is Life Cycle Management for Products that has
either been in the market or that needs to be newly launched. In both these scenarios it is extremely important to make sure that Product dossiers are maintained&updated such that the manufacturing unit/site documentation is sort of a mirror image of the product dossiers. These dossiers could be as much as approved or must be in a state where the variation file/amendment is filed with the HA. Now why do we need to maintain a product life cycle?
Itwas all the while important to file newproduct dossiers&obtain registration. Especially in the emerging markets (which is rather emerged) Product approvals are much sought after but seldom does one think of Life cycle management. In markets like South Africa, Latam region, Asian region especially Malaysia, Thailand&Singapore, life cycle management is done in the form of filing an amendment or a variation which is done in an extremely formal mechanism. There are guidelines defining the kind of change& the documentation that would be required to support this change.
The management of this change gives rise to a new facet which is COMPLIANCE. Thus it can be drawn to a fact that how one handles change management for a product. How one is compliant with respect to the applicancy. It is now expected that the Applicant remains always compliant with respect to the dossiers & the
manufacturing site. Compliance also is a field where there is a very close interface between Quality Unit & Regulatory Unit of an organisation. Transparency between Regulatory and other functions such as productionand QA for flow of information is a key to avoid unwarranted delays implementing the required changes with RA consent. Fulfilment of commitments in registration file in a timly manner is another important activity in compliance In otherwords . LCMis howone raises a product dossier post the first registration.