Regulatory Affairs Articles
Regulatory Affairs Outsourcing
Regulatory Affairs Unit in a pharmaceutical company is a vital unit that drives the R & D efforts of the company to the market successfully. Today a Regulatory Affairs department is a dynamic business unit which works with a focus to get products to the market with a commercially viable label in the least possible time and expenses.
Today the world has become a global village and many companies are in a race to place many new products in the world markets to gain market share and increase earnings. In such a scenario a small delay in gaining market access means huge loss in terms of market share and revenue generated. The key to success for pharmaceutical companies lies in obtaining timely marketing approval from regulators.
So to obtain timely marketing approval companies can either strengthen then regulatory department or outsource the same to regulatory affairs consulting firm.
With changing global regulatory norms, outsourcing regulatory affairs work seems a more beneficial option both in terms of time and money. Maintaining a large regulatory affairs department can be very expensive and scope of knowledge can be limited to certain aspects. On the other hand a regulatory affairs consultant keeps on updating himself with the current regulation and has vital experience in the field to expedite the approval process.
This article further explores the services provided by regulatory affairs professional and the key points for proper selection.
Regulatory Affairs: For full Article
Six Golden Rules Of Validation
Draft the Most Standard Validation
Drafting a protocol for validation is not a simple task. The protocol should be designed by the validation team and verified with the supplier of machine.
Most common error in drafting protocol is
- Protocol is not relevant.
- Protocol does not cover critical feature of design, operation or performance.
- Acceptance Criteria not well defined.
- Provision for statistical analysis is not present.
- Validation report not available
- Instructions for recording the data not provided.
- No details on Annual validation activities.
- No details on labeling of equipments on actual date of validation and due date for validation.
- No details on archiving of validation studies and data.....
Author : Mr R M Gupta .....Visit the Resource-Center for full article.