Quality Systems
Quality is of utmost importance in the pharmaceutical field. We ensure that all the products that are manufactured by our company meet the standard and intended specifications of quality and purity.
Quality Control (QC)
The main aim of Quality control is to check whether the products meet the specifications and requirements of the client. We ensure that all the products that are manufactured by our company meet the standard and intended specifications of quality and purity.
Our dedicated, hard working Quality Control (QC) team works round the clock to ensure that every product manufactured by us complies with all international standards of quality, purity and efficacy. Our team performs comprehensive tests according to pharmacopeias (Ph.Eur., USP, IP) for inhouse developed as well as validated analytical methods as per client requirements. The team also reviews the tests that are in compliance with ICH guidelines.
Our QC department is equipped with the following machines/apparatus of top-notch manufacturers:
- HPLC with PDA detector | Shimadzu
- HPLC with UV detector | Shimadzu
- HPLC with PDA detector | Waters
- UV Spectrophotometer | Shimadzu
- Gas Chromatograph (GC) | Perkin Elmer
- IR Spectrophotometer | Perkin Elmer
- Stability Chamber (25+2°C/60+5% RH) 1000 Lit | Newtronic
- Stability Chamber (30+2°C/65+5% RH) 1000 Lit | Newtronic
- Stability Chamber (40+2°C/75+5% RH) 1000 Lit | Newtronic
- Cooling cabinet (Temp 5+3°C) | Newtronic
- Analytical Balance | Radwag
- KF Titrator | Melting point apparatus | pH Meter | Polmon Instruments
- Conductivity/TDS meter | Polmon Instruments
- 1 Weighing Balance
We plan to enhance our QC department with further equipment in the near future as per our client demands and requirements. We have established stringent Quality Compliance as per ICH Q7 for the production of APIs as per cGMP.
The Company is committed to achieving customer satisfaction by the use of quality procedures which will be operated to meet or exceed the requirements of ISO 9001.
Quality Assurance (QA)
Our Quality assurance team assesses client’s requirements and ensures that these requirements are met. QA systems at Maithili Life Sciences are ICH and ISO compliant.
The QA systems are independent from production.
The many responsibilities of the QA team include, but are not limited to:
- Ensuring cGMP across the Manufacturing area
- Conducting Vendor qualification
- Compliance of In-process monitoring
- Review of Process and method validations
- Maintaining and tracking Change control procedure
- Conducting Annual product review
- Conducting self audit and compliance of audit observations
- Maintaining and tracking Deviation control procedure
- Coordinating the handling of complaints
- Reducing the risk of Product recalls and returns
- Ensuring compliance of various quality measures by appropriate requisite documentation
- Reviewing of Batch records
- Handling OOS (Out of Specifications) results
- Tracking Water/HVAC monitoring
- Reviewing of Stability study as per ICH guidelines
- Conducting Training programs
The Quality assurance team ensures that API’s and advanced intermediates produced during the various stages of manufacture comply with the cGMP Requirements. Further, the QA team is responsible for site specific, maintenance, compliance, realization and advanced development of internal Quality Management Systems (QMS). They plan, direct or coordinate quality assurance programs and formulate quality control policies.
Our Regulatory Affairs team works with project teams and interacts with the regulatory health agencies, such as the Food and Drug Administration (FDA) or the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and anticipates what the regulatory authority will require before approving the product.
Our Regulatory Affairs personnel are responsible for tasks involving evaluating dossiers/queries and compilation of critical dossiers and queries, as and when required. They are also responsible for registration of products in various countries abroad as per the registration guidelines as well as filing of DMF’s in regulated markets.
Quality Systems
QA Systems at Maithili Life Sciences are ICH & ISO compliant and are independent from production.
- Vendor Qualification
- In-process monitoring
- Change Control Procedure
- Annual Product Review
- •Self Inspections
- Deviation Control Procedure
- Complaint Handling
- Product Recall and Returns
- Document Control
- Review of Batch Record before Release
- Training and Development
- Handling Out of Specifications
- Water/HVAC system monitoring
- Stability Study Program as per ICH
- Process and Method Validations
Environment, Health and Safety (EHS)
