Revised Schedule M Implementation: Contact MedDev Experts for a Seamless Transition
Experienced Consultant for Implementation of Revised Schedule M
Struggling with revised Schedule M compliance? MedDev Experts offers expert consultancy for implementing the revised Schedule M in pharmaceutical industries. Our experienced team provides gap analysis, compliant layouts, documentation, and training for CDSCO and WHO GMP compliance. Contact us today.
What's New in the Revised Schedule M?
The revised Schedule M introduces several significant changes aimed at enhancing the quality and safety of pharmaceutical products in India. These changes are intended to improve the overall quality and safety of pharmaceutical products manufactured in India and to enhance the country’s reputation as a reliable supplier of pharmaceuticals to the global market. Here are some key highlights:
Pharmaceutical Quality System (PQS):
Implementing a comprehensive system that ensures consistent product quality throughout the manufacturing process and to prevent defects, ensure product safety, and meet regulatory requirements.
Quality Risk Management:
A systematic process to identify, assess, and control risks that could affect product quality through Failure Mode and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), and risk assessment matrices
Product Quality Review:
Regularly reviewing product quality data to identify trends, deviations, potential issues, and areas for improvement.
Qualification and Validation:
Ensuring that the validated processes and qualified equipment, and facilities are used to ensure that products are manufactured consistently and meet quality standards. It includes Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
Change Control:
A systematic process for managing changes to manufacturing processes, facilities, or documentation in a controlled manner. It helps to minimize risks associated with changes and ensure that product quality is maintained.
Production under Loan License or Contract:
Overseeing production activities conducted under loan licenses or contracts.
Contract Analysis and Other Activities:
Managing contracts, conducting market research, and engaging in other relevant activities.
Self-Inspection:
Conducting regular self-inspections to identify and address non-compliances.
Quality Audits and Suppliers' Audits and Approval:
Conducting audits of internal and external suppliers to assess their quality systems.
Good Manufacturing Practices (GMP) for Production:
Adhering to GMP guidelines for production processes.
Good Manufacturing Practices (GMP) for Quality Control:
Implementing GMP standards for quality control activities.
Computerized Systems:
Ensuring the validation and security of computerized systems used in pharmaceutical manufacturing.
Deadline for Implementing Revised Schedule M
Large pharmaceutical companies (turnover > ₹250 crore) must comply with Revised Schedule M by January 1st, 2024. Smaller companies have until June 1st, 2024. This deadline ensures alignment with global standards, improving product quality and export potential.
Seeking a Revised Schedule M Consultant?
Let MedDev Experts guide you through the complexities of Revised Schedule M. Ensure seamless compliance, optimize processes, and mitigate risks. Don’t let it be a burden. Partner with us for expert support.
Contact us for a free consultation
How MedDev Experts can help you to implement the Revised Schedule M?
- Deep-rooted Expertise: With over 30 years of experience in the pharmaceutical industry, we have a proven track record of delivering successful solutions to implement the rules.
- Customized Approach: We tailor our services to meet your unique needs, providing practical guidance and support at every stage.
- MNC Collaboration: Our experience working with multinational pharmaceutical companies ensures that we understand the challenges and complexities of the industry.
- Comprehensive Solutions: From regulatory compliance to process optimization, we offer a holistic approach to Schedule M implementation.
Benefits of Working with Us
- Regulatory Compliance: Ensure adherence to the revised Schedule M requirements, including documentation, record-keeping, and quality control.
- Process Optimization: Streamline your operations to improve efficiency, reduce costs, and enhance product quality.
- Risk Assessment: Identify and mitigate potential risks associated with Schedule M implementation, ensuring a smooth transition.
- Training and Development: Provide your staff with the necessary knowledge and skills to effectively implement and maintain compliance with the revised Schedule M.
Looking for Comprehensive Revised Schedule M Solutions?
Contact MedDev Experts for:
- Plant Upgrades
- Layout Optimization
- Standard Operating Procedures (SOPs)
- Analytical Method Validation
- Process Validation
- Pharmaceutical Product Development
- Dossier Preparation
- Common Technical Document (CTD)
- Product Dossier
- Pharmaceutical Quality System (PQS) Implementation
- Water System Validation
- Equipment Qualification (DQ, IQ, OQ, PQ)
- Cleanroom Setup
- Software Validation
- Training
- Vendor Qualification
Ready to partner with MedDev Experts? Contact us today to schedule a consultation and learn how we can help you navigate the revised Schedule M landscape.