The New Schedule M represents a comprehensive framework introduced by the Central Drugs Standard Control Organization (CDSCO) in India, aimed at regulating and standardizing pharmaceutical manufacturing practices. It encompasses various aspects including facility design, equipment qualification, process validation, documentation, and quality management systems. One of the key objectives of the new schedule is to align with international standards such as Good Manufacturing Practices (GMP) to ensure the production of safe and high-quality pharmaceutical products.
Some of the Key Concepts of New Schedule M:
Quality Management Systems (QMS): Implementing a robust quality management system is essential for ensuring compliance with regulatory requirements and fostering a culture of quality within pharmaceutical organizations. The New Schedule M emphasizes the establishment of QMS frameworks that encompass all aspects of manufacturing operations.
Risk-Based Approach: The new schedule emphasizes the adoption of a risk-based approach towards pharmaceutical manufacturing. This involves identifying potential risks at various stages of production and implementing appropriate controls to mitigate them.
Life Cycle Approach: Adopting a life cycle approach is fundamental to ensuring the continual improvement and sustainability of pharmaceutical manufacturing processes. The New Schedule M encourages manufacturers to consider the entire life cycle of products and processes, from design and development to decommissioning.
Qualification of Utilities: The New Schedule M emphasizes the importance of qualifying utilities such as water systems, HVAC (Heating, Ventilation, and Air Conditioning) systems, and compressed air systems to ensure their reliability and suitability for pharmaceutical manufacturing operations.
Process Validation: Ensuring the consistency and reliability of manufacturing processes is crucial for maintaining product quality. The New Schedule M emphasizes the importance of process validation, requiring manufacturers to validate critical processes and equipment to demonstrate their effectiveness.
Computer System Validation: In today's digital age, the use of computerized systems is pervasive in pharmaceutical manufacturing, ranging from manufacturing execution systems (MES) to laboratory information management systems (LIMS). The New Schedule M emphasizes the validation of computerized systems to ensure data integrity, security, and compliance with regulatory requirements.
Stability Studies: Stability studies are critical for determining the shelf life and storage conditions of pharmaceutical products, ensuring their efficacy and safety throughout their intended lifespan. The New Schedule M outlines requirements for conducting stability studies to assess the stability of finished products under various storage conditions. This includes defining stability protocols, conducting stability testing at different time points, and analyzing the data to establish product shelf life and storage recommendations.
Analytical Instrument Qualification: Accurate and reliable analytical testing is essential for ensuring the quality and consistency of pharmaceutical products. The New Schedule M emphasizes the need for qualifying analytical instruments to demonstrate their accuracy, precision, and reliability for intended use.
ISPE India Foundation A NON-PROFIT ORGANISATION serves as a valuable resource for pharmaceutical professionals seeking guidance and support in implementing the requirements of the New Schedule M.
Here we present webinars by leading experts who present the science behind the concepts and requirements mentioned above. These webinars were hosted in the year 2021 and 2022. many of THESE PRESENTATIONS EXCEED WHAT IS MANDATED BY SCHEDULE M.
However, our purpose is to present the Best Practices so that once these concepts are grasped the professionals can then decide how to implement these concepts in their organisation to meet specific Schedule M Requirements.
We will be conducting Webinars in the Next few months to deal with some of the specific requirements of Schedule M.
STAY TUNED
Karen Ginsbury :
The objective of this webinar is to understand what Quality is and what a QMS is supposed to do and how it should do it. Where the GMPs fit into the QMS and how, with intense and close regulatory scrutiny, is it possible to manage a truly effectiveness and robust system.
Kate Coleman
This webinar will discuss how to get the most benefit from a QRM program so that it delivers its full potential as a powerful tool for decision making, prioritisation, efficiency, continuous improvement, training and knowledge management.”
Tim Fischer
In this webinar, we will explore the basis and development of a good CAPA program including what critical quality oversight and management review should entail. We will also explore the 7 tenants of a good CAPA process.
Nissan Cohen
This webinar delineates the need for creative ideas for the design and operation of water systems during monsoon season.
Stephan Newman
In this webinar various sanitization concepts and why these are necessary to avoid biofilms are discussed. A brief overview on biofilms and some examples of biofilms contamination are also presented.
Nissan Cohen & Nick Haycocks
About the webinar
Water is the most widely used substance, raw material or starting material in the production, processing and formulation of pharmaceutical products. The presentation will provide an overview a process for the Commissioning and Qualification of a WFI system following the approach described in the baseline guide, and discuss how the use of instrumentation can be integrated into the approach.
Norman Goldschmidt
For over a decade India has been a key link in the global supply chain of Pharmaceuticals, supplying not just API’s, but complete dosage forms. As manufacturing becomes more sophisticated and closer to the end user, the patient, regulatory expectations increase. In this class we will discuss how FDA expectations for environmental control compare with EMA – PIC/S, WHO and others.
Aaron Mertens
This Webinar will provide an overview of microbiology principles in steam sterilization and application, as well as autoclave Performance Qualification, regulatory expectations and cGMPs. The presentation will highlight common questions and hot topics in industry to demonstrate the practical application of understanding steam sterilization.
Stephan Neuman will will present an overview on the applicable regulations, norms and guidelines and also some common practices.
Thomas Altman
This webinar summarises the global regulatory guidelines leading to all the changes for cleaning and its validation within the pharmaceutical industry.
Beth Kroeger, Richard Chai and Paul Lopolito
This conference has presentations on "Important Considerations in Cleaning Process Development" and "Biofilm remediation and removal".
Session 1 : Preventive Maintenance on Stainless Steel System by Richard Chai & Paul Lopolito
Session 2 : A Risk Based Contamination Control Strategy by Jim Polarine
Session 3 : Surface decontamination with VHP – Fundamentals & Facility Integrations by Nicholas Tan & Bruno Aze
Sara Levy
In this webinar Sara Levy will explain how to implement a sound Risk Management Programme while validating a computer system.
Joachim Ermer
In this Webinar Learn
Development towards life cycle approaches
Draft: Analytical Target Profile (ATP) and 3-Stage approach
ICH Q12
ICH Q2 Revision and new Q14 Guideline
Tara Scherder & Keyur Doshi:
In this webinar learn how science and risk-based principles can be applied across the process lifecycle.
The information collected when you register for a webinar will not be shared with any organization and will not be used for any commercial purposes. We follow the provisions of Indian Information Technology Act to protect your data.
pbpwindia@gmail.com
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