PROCESS VALIDATION

Process validation, according to the FDA, is “…the gathering and evaluation of data, from the stage of process design to commercial production, which establishes scientific evidence that a process is capable of reliably providing quality output.”

The lifecycle idea is a cornerstone of this FDA guidance statement. The lifecycle approach takes into account not only the earliest stages of medication research but also the creation of commercial manufacturing and ongoing commercial production up until the product is discontinued.

The need for quality assurance measures to be incorporated into each stage of the medication manufacturing process is another fundamental idea behind validation.

The 3 stages of process validation are:

• Process Design – The commercial manufacturing process is defined.
• Process Qualification – The design is evaluated to determine whether the processes meet demands of reproducibility.
• Continued Process Verification – Ongoing assurances that all processes remain in a state of control.

1. PV Protocol (Uncoated Tablets)
2. PV Report (Uncoated Tablets)
3. PV Protocol (Coated Tablets)
4. PV Report (Coated Tablets)
5. Process Validation Protocol of Pyridoxine Sustained Release Tablets
6. Process Validation Report of Pyridoxine Sustained Release Tablets
7. Packing Process Validation Protocol for Strip (Ferrous Ascorbate, Folic Acid and Cyanocobalamin Tablets)
8. Process Validation Protocol for Acyclovir (Sterile)
9. Process Validation Report for Acyclovir (Sterile)
10. Process Validation Protocol for Pantoprazole Sodium (Sterile)
11. Process Validation Report for Pantoprazole Sodium (Sterile)
12. Process Validation Protocol for Calcitriol & Multivitamin Softgel Capsules
13. Process Validation Report for Calcitriol & Multivitamin Softgel Capsules
14. Process Validation Protocol for Ciprofloxacin Ophthalmic Solution BP 0.3% (5 ml)
15. Process Validation Report for for Ciprofloxacin Ophthalmic Solution BP 0.3% (5 ml)
16. Process Validation Protocol for Lidocaine Injection BP 2% w/v, 20 ml
17. Process Validation Report for Lidocaine Injection BP 2% w/v, 20 ml
18. Process Validation Protocol for Tranexamic Acid Injection BP 100 mg per ml (500 mg in 5 ml) Ampoule Section
19. Process Validation Report for Tranexamic Acid Injection BP 100 mg per ml (500 mg in 5 ml) Ampoule Section
20. Process Validation Protocol for Sugar Sphere
21. Process Validation Report for Sugar Sphere
22. Process Validation Protocol for Levocetirizine Dihydrochloride Syrup
23. Process Validation Report for Levocetirizine Dihydrochloride Syrup
24. Process Validation Protocol for Prebiotic and Probiotic Hardgel Capsules
25. Process Validation Report for Prebiotic and Probiotic Hardgel Capsules
26. Process Validation Protocol for Dutasteride Pellets (0.5%)
27. Process Validation Report for Dutasteride Pellets (0.5%)