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