Quality Control
Non-Negotiable QUALITY CONTROL
C2C Pharma has established the Quality Control & Quality Management System (QMS) to comply with international standards and regulatory authorities
The Quality Control and Microbiology Department at C2C Pharma Ltd. is a crucial pillar of assurance, ensuring pharmaceutical products meet and exceed the highest standards of quality, safety, and efficacy. QC department completely analysis by performing on input materials, intermediates, bulks and finished products using classical analytical “wet chemistry” techniques as well as sophisticated instrumentation such as HPLC, FTIR, UV-VIS Spectro-photometer, Karl Fisher Titrator, Potentiometric titrator, dissolution tester, to name a few. The laboratory is also equipped with the necessary equipment including Autoclave, Incubators Bio-safety Cabinets Class II for microbiological work.
Validation & Qualification
In the pharmaceutical industry, validations play a paramount role in ensuring the safety, efficacy, and quality of drug products and processes. C2C Pharma Ltd. is renowned for its robust validation activities. With a steadfast commitment to adhering to rigorous regulatory standards and ensuring product excellence, the company excels in a range of validation processes.
Cleaning Validation
Ensures that equipment, facilities, and utensils used in drug manufacturing are free from residues of previously manufactured products, cleaning agents, and microbial contaminants. This is crucial to prevent cross-contamination and ensure the purity of subsequent batches.
Process Validation
Confirms manufacturing process consistently produces drugs with the desired quality. It involves demonstrating control over critical process parameters
and ensuring that the process remains within established limits.
Analytical Method Validation
Demonstrates that analytical methods used for testing the products are accurate, precise, specific, and reliable. It ensures that the analytical results obtained are meaningful and can be used to make informed decisions about product quality.
Shimadzu’s Network-Enabled Data System
LabSolutions CS
LabSolutions features an innovative operating environment and provides complete data management to ensure secure information in networked laboratories. C2C Pharma has installed world renowned Lab Solution from Shimadzu Japan.
- Network system comply with Regulations
- Unified data management of Laboratory
- Efficient Operation and System Management
- Cooperation with other systems likes LIMS
- Total support for Regulatory Compliance
- Safe and secure data management
- No chance of data manipulation
- Complies with 21 CFR Part 11, as required by the US FDA