Generic pharmaceuticals from India have flooded the market in recent years. Billions of pills get produced each year, and maintaining and documenting good manufacturing practices is vital to ensure the quality of these drugs.
Generic pharmaceuticals from India should be manufactured in accordance with CGMP (Current Good Manufacturing Practices) standards. These are the same guidelines that brand name manufacturers must follow. Inspections by a 3rd party can help ensure compliance with these regulations. Documentation of proper manufacturing practices is important to maintain in order to show proof of quality control.
Constant monitoring and quality control are vital to ensuring the safety and efficacy of generic pharmaceuticals from India. 3rd party inspections can play an important role in maintaining quality control by providing unbiased reports and documentation of proper manufacturing practices.
The quality of the pharmaceuticals produced is directly correlated with the quality of ingredients used--which needs to be monitored constantly.
This can be done by DUPRO (During Production Inspections), Inspectors who during the production process inspect various stages through sampling, verification and comparisons. DUPRO certifies that the manufacturing has been to the specifications.
Over an above audits and during production inspections the final products need to be verified and inspected before shipping.
When doing a pre-shipment inspection on pharmaceuticals inspectors would look for the following:
- The drug must be manufactured in a facility that is approved by the country of import. (Verified with Audits)
- The drug must meet the quality standards of the country of import. (Verified with DPI)
- The drug must be labeled and packaged correctly and according to regulations of the importing country. ( Verified with Pre-Shipment)
If Generic pharmaceuticals from India meet these quality standards, they can be considered safe and effective for use, and should be able to be processed through customs and sold in the importing countries.
If you are importing generic pharmaceuticals, both DUPRO and Pre-shipment inspections should be a part of your process. Both play vital roles in ensuring your generic pharmaceuticals meet all import regulations.
If you don't have these procedures in place Inspexion can help you. We have experienced QC companies and Freelance inspectors in India ready to be part of your inspection plan. You can request, manage and receive your reports on all your pharmaceutical inspections from one dashboard.
You can request a pharmaceutical inspections ranging from an Audit for Current Good Manufacturing Practices to a Bio-Analysis of the chemical compounds on Inspexion.com, specify your timeline, and have the QC Companies in India quote you immediately.