RESEARCH AND DEVELOPMENT

1. After getting product proposal, product brief from marketing department R&D department start feasibility study.

2. Start collecting information about that product from all possible sources i.e. IP, BP, USP, BMF, Physical Desk reference, the electronic media compendium, Mark Index, Martindale, Patent Manufacturer of the API etc.

3. Summarize or highlight that information vital for formulation in the preformulation study and discuss with team members through a meeting if required.

4. Collect the sample of the product from market, preferably from patent manufacturer or of leading brand company. Check the physical parameters of the market products to set specifications of our final product.

5. To specify pharmacopoeia claim in the raw material and product, conduct meeting with quality control and decide pharmacopoeia claim of RM and product.

6. Make sure about availability of active ingredients and excipients in store if not available order the material i.e. raw materials and packaging material from the approved vendor.

7. After availability of material get preliminary idea about the formulation, make trial of minimum units of each dosage form and record on the trial batch.

8. Send the trial batch for QC analysis and figure out best probable formulation.

9. Based on the information collected in preformulation study and considering trial batch formulation confirm, prepare BMR and take three batches by using same formulation and procedure.

10. Submit the sample for analysis and compare the results with specification previously set by the QC Department.