Quality Control & Assurance
Hermes recognizes that quality is the most important attribute and is committed to total quality management that confirms to National and International Regulations. The manufacturing process is carried out under strict supervision of our technically competent staff as per the predefined processes and procedures. To ensure that the cGMP standards are met and products comply with international quality standards, quality control measures have been implemented at various stages of production starting from approval of raw materials, in-process materials and extend to checking of finished products.
The Batch Manufacturing Records and Batch Packaging Records are maintained for all manufactured products. The final products are tested to the strictest of the available international pharmacopeias standards and norms. Stability studies are conducted on all our manufactured products.
We have the requisite Infrastructure and expertise to ensure proper regulatory approvals by our clients and international regulatory bodies such as USFDA, TGA, KFDA, EDQM, COFEPRIS, ANVISA, UKMHRA etc.
The QA department ensures that all activities associated with the design, development and manufacturing (Purchase, Warehouse, Production, Quality Control, Release and Distribution) of Active Pharmaceutical Ingredients and Intermediates are carried out in a systematic and approved manner in the compliance with the regulatory and the Good Manufacturing Practices (cGMP) requirements which has ensured a zero rejection rate.
Some of the functions performed by our Quality team are:
- Raw material analysis and approval
- Batch Analysis and Approval
- Stability Studies
- Stressed and Forced Degradation Studies
- Control Samples
- Wet and Thermal Analysis
- Preparation, Implementation and the Period Review of the Standard Operation Procedures (SOP’s)
- Instrument and Equipment Qualifications and its periodic calibrations
- Qualification of Air quality, Water quality and machinery along with periodic calibration of gauges etc.
- Process Validation and Method Validation.
- In Process Controls
- Technology Transfer
- Documentation Control
- Audit of manufacturing facilities and auditing suppliers of the critical raw materials
- Personnel training programs
- Surprise Audits
- Change Control
- Handling deviations, customer complaints, implementation of the corrective and preventive actions.
- Capability to develop and file CTD DMF, US DMFs, CEP and other registrations required in the various markets which is supported by our well equipped QC.