Quality Control & Assurance
Neuland believes in providing the quality that the customer wants. Every activity from order processing and procurement of materials to final shipment of the consignment to the customers is monitored to provide the customer the 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. The team has a clear understanding of the possible direction of regulations and standards so that they could be put in place sooner, rather than later.
The manufacturing facilities ensure compliance and care is taken to continuously monitor the cGMP guidelines established by ICH (Q7A) 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.
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. Some of them include:
- 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 & calibration programs
- Stability testing of products
- Microbial limit tests & BET testing on products