Quality Control

Neuland believes in meeting or exceeding the quality levels set by the customer, and always obeys stringent international standards. Every activity, from order processing and procurement of materials to final shipment of the consignment to the customers, is monitored to provide the customer with assured quality.

Continuous improvement of products and process and commitment to quality has led to enhanced attention to detail for products sold in all markets. Our team has a clear understanding of the possible direction of regulations and standards so that we are implementing policy ahead of legislation. The manufacturing facilities ensure compliance and care is taken to continuously monitor the cGMP guidelines established by ICH (Q7) and relevant requirements of FDA, ICH, EMEA and EDQM. Stringent controls are built in to ensure that every single product meets the specification of all pharmacopeias and our customer requirements.

Processes

The systems and processes are supervised on on-going basis to ensure the products meet the needs of the customers. There are several steps the Company takes to achieve its standards. This is a snap shot of some of the processes:

• Sampling and analyzing products and impurities
• In-process tests for production
• Microbiology laboratory in line with international standards
• Sampling, test and decision of starting materials as well as all subsequent inputs, intermediates, and finished products support full cGMP operations
• Analytical methods development & validations
• In-process control of production operations
• Maintain internal instrument qualification and calibration programs
• Stability testing of products
• Microbial limit tests & BET testing on products

The R&D facility is USFDA approved as a testing facility for Unit I and Unit II.