Revised Schedule M – Revolutionising pharmaceutical marketing

Short Description

In an effort to bring the nation’s pharmaceutical and biopharmaceutical quality standards up to par with those of other countries, the Union Health Ministry has notified the public of the revised Schedule M norms for good manufacturing practices and requirements of premises, plant, and equipment for pharmaceutical products. These provisions include an annual Product Quality Review (PQR), Quality Risk Management (QRM), Pharmaceutical Quality System (PQM), etc.

Overview

As per the notice dated 28th December 2023, the Ministry of Health and Family Welfare (MoHFW) has released updated regulations under Schedule M of the Drugs and Cosmetics Rules, 1945, marking a major step toward improving adherence to quality standards.

These regulations, which include the good manufacturing practices (GMP) for pharmaceuticals, are intended to change the way that pharmaceuticals are made in India.

Key changes in the Revised Schedule M

The revised Schedule M includes a number of significant adjustments that have the potential to completely alter the operational dynamics of the pharmaceutical sector. These include the incorporation of:

• Pharmaceutical quality system (PQS)
• Quality risk management (QRM)
• Product quality review (PQR)
• Qualification and validation of equipment.
• Implementation of a computerized storage system
• change control management
• Establishing a complaint and product recall procedure

The key aspects of the proposed amendments include the change of the terminology “Good Manufacturing Practices” in Rule 74 (clause o), Rule 76 (clause 8), and Rule 78 (clause p) to “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products.”

Pharmaceutical Quality System

In order to guarantee that pharmaceutical products are safe for the intended purpose, meet license criteria, and do not endanger patients through subpar safety, quality, or efficacy, the producer has the responsibility for the products’ quality. Senior management bears the responsibility for achieving this quality target, which relies on the involvement and dedication of employees across all departments and levels of the business, as well as suppliers and distributors.

Quality Risk Management

Quality risk management is a methodical approach to the assessment, management, review, and communication of risks to the pharmaceutical product’s quality. It can be used in a proactive or retrospective manner.

Quality Risk Management is to guarantee that:

• The risk to quality is evaluated using scientific knowledge and experience with the procedure, and that it ultimately relates to patient protection; and 
• The degree of formality, effort, and documentation of the quality risk management process is commensurate with the degree of the risk

Product Quality Review

Regular, periodic, or rolling quality reviews of all pharmaceutical products, including those intended solely for export, must be carried out in order to identify areas for improvement in both the finished product and starting materials specifications, as well as to confirm that the current process is consistent and appropriate.

Taking into consideration earlier assessments, these evaluations should typically be carried out and recorded once a year.

Qualification and Validation

Each pharmaceutical company must determine what certification and validation work is needed to demonstrate that the crucial components of their specific operation are under control in compliance with GMP.

The purpose of qualification and validation is to prove, through documentation, that:

• Compliance with Good Manufacturing Practices – The buildings, processes, equipment, and supporting utilities have been designed in compliance with good manufacturing practices requirements.
• Construction and Installation to Design Specifications – The buildings, processes, and equipment have been constructed and installed in accordance with their design specifications.
• Functionality of Buildings, Utilities, and Equipment – The buildings, supporting utilities, and equipment function as intended.
• Process Reliability and Product Quality – A particular process will reliably yield a product that satisfies its predetermined specifications and quality attributes.

Computerised Storage System

Computerized systems must have enough controls in place to stop unauthorized users from accessing or altering data. Furthermore, controls must be in place to avoid data omissions (such as when the system is turned off and no data is recorded). Every modification to data must be documented, including with the prior entry, the person making the change, the date it was done, and the details.

To ensure that records are never permanently lost as a result of system failure or breakdown, a backup solution must be offered. Every computerized system must have set methods for guaranteeing data safety.

Implementation Timeline

The timing for the implementation of the Drugs (Amendment) Rules, 2023 is an important point to take into account as they go into effect. The goal of this timeline is to offer an organized method for compliance by classifying pharmaceutical businesses according to their turnover.

Manufacturers are divided into 2 categories concerning their turnover:

How can CliniExperts help?

With more than ten years of experience in the industry, CliniExperts is a comprehensive regulatory solutions provider. The team’s expertise and wide industry networks make it easy to ensure compliance with the latest and revised schedules while diligently following strict timelines enforced. CliniExperts can help to ensure good manufacturing practices and requirements of premises, plant, and equipment for pharmaceutical products.

Conclusion

The revised rules will solve the majority of problems pertaining to documentation, failure investigation, and technically qualified individuals. It will assist the organization in building a strong quality management system, enabling the creation of high-quality medications that are acceptable throughout the world.