Formulation Development, review and validation of manufacturing methods |
We can undertake formulation development for you from the initial stage or improve upon specific problems faced in existing formulations, i.e., complete technical know-how can be provided. All Pharmacopoeial and Regulatory requirements are kept in mind while designing your formulation so that the best results can be delivered. Review of a current formulation may be done to improve stability and hence shelf-life, effectiveness in terms of better bio-equivalence and bio availability, or to provide sustained release, delayed release and other type of modified release, development of coatings; improvement of dissolution pattern etc. in solid dosage forms, development of bases for creams, ointments and clear or translucent gels for specific active ingredients, taste masking for liquids and solid dosage forms, improvement in the aesthetic look and finish of the product and any other problems that you face in particular. To validate your manufacturing methods, processes, machinery and equipment is very important to achieve standardization, one of the keys to GMP. Validation is essential to demonstrate the consistency as well reliability of processes and their ability to achieve desired results in manufactured lots within certain parameters and conditions on a repeatable basis. PharmAtoZ’s team of experts can help you with designing and implementing a comprehensive validation programme for your manufacturing methods for compliance with GMP and Regulatoy requirements. We can provide validation services for new processes as well as for established processes due to changes in regulatory requirements, changes in lot sizes and various other factors. |
