Regulatory Compliance
At Talwar Pharma, regulatory compliance is not just a requirement—it is a commitment to excellence and ethical responsibility. As a GMP-certified pharmaceutical company, Talwar Pharma strictly adheres to national and international pharmaceutical regulations and standards. The goal is to ensure every product that leaves the facility is safe, effective, and of the highest quality, fostering trust with consumers, regulators, and partners alike.
1. Regulatory Framework
Talwar Pharma’s regulatory compliance is guided by frameworks such as:
Good Manufacturing Practices (GMP)
World Health Organization (WHO) Guidelines
Indian Pharmacopoeia (IP)
U.S. FDA and EMA (for export markets)
This ensures products meet stringent safety, efficacy, and quality parameters.
2. Licensing and Certifications
Talwar Pharma holds all required manufacturing and operational licenses under the Drugs and Cosmetics Act. These include:
GMP Certification
Drug Manufacturing License
Pollution Control Compliance
Fire and Safety Certifications
Each document is reviewed and renewed in compliance with state and central regulatory bodies.
3. Standard Operating Procedures (SOPs)
Regulatory compliance at Talwar Pharma is implemented through a robust set of SOPs that govern every process, from raw material procurement to final product dispatch. These SOPs are:
Reviewed periodically
Aligned with latest industry regulations
Approved by QA/QC departments
4. Documentation and Records
Meticulous documentation is a cornerstone of Talwar Pharma’s compliance culture. Records are maintained for:
Batch manufacturing and packaging
In-process and finished product testing
Equipment calibration and maintenance
Training and audits
Every action is traceable, ensuring full transparency.
5. Audits and Inspections
Internal audits are conducted regularly to identify potential gaps and address them proactively. External audits include:
Regulatory body inspections
Client and third-party audits
Certification renewals
All audit findings are followed up with corrective and preventive actions (CAPA).
6. Quality Agreements and Compliance Contracts
Talwar Pharma enters into detailed quality agreements with its partners and clients. These agreements outline:
Responsibility matrices
Testing protocols
Compliance benchmarks
Data integrity standards
This approach ensures clear accountability and standardization.
7. Change Control System
Any change in manufacturing, testing, or packaging processes is controlled through a documented change control system. The process involves:
Risk assessment
QA approval
Regulatory impact evaluation
Documentation update
This ensures no change compromises product quality or compliance.
8. CAPA (Corrective and Preventive Action)
When deviations or non-conformities are identified, Talwar Pharma initiates CAPA protocols. Steps include:
Root cause analysis
Immediate containment
Corrective measures
Preventive strategies
Each CAPA is logged and tracked until resolution.
9. Training and Competency Development
Continuous training programs ensure that all employees understand their compliance responsibilities. Training includes:
GMP practices
Data integrity and documentation
Regulatory updates
Audit preparedness
Regular assessments are conducted to validate understanding and skill retention.
10. Regulatory Submissions and Dossiers
Talwar Pharma’s Regulatory Affairs team compiles and submits dossiers for new product approvals, license renewals, and export compliance. Submissions include:
CTD (Common Technical Document) format
Safety and efficacy data
Stability studies
The team ensures on-time and error-free submissions to authorities.
11. Environmental and Safety Compliance
Talwar Pharma complies with all environmental and occupational health standards. Practices include:
Safe waste disposal
Use of eco-friendly materials
Fire drills and equipment maintenance
Safety training for all staff
This holistic approach enhances the company’s credibility.
12. Digital Compliance and Data Integrity
All data systems are validated and access-controlled to ensure:
Data security
Backup and recovery protocols
Tamper-proof audit trails