GMP and Schedule M Audit Service for Pharmaceutical Facilities

All pharmaceutical manufacturing facilities in India are required to comply with the Schedule M guidelines. The guidelines are intended to change the way pharmaceuticals are manufactured in India bringing them at par with global standards. However, ensuring compliance with all the clauses and requirements of the Schedule M guidelines can be cumbersome. Hence, opting for a GMP and Schedule M audit service can help pharma companies easily comply with Schedule M guidelines. Furthermore, it can help them avoid the hassles associated with regulatory non-compliances.

Our audit service has been developed to provide insights and guidance required to navigate the complexities of Schedule M guidelines. Additionally, it will help you mitigate risks and achieve operational excellence. Our team has extensive expertise in GMP and Revised Schedule M guidelines. Additionally, we have in-depth knowledge of the pharmaceutical industry and CDSCO regulatory guidelines. We have conducted more than 60 GMP and Revised Schedule M audits helping pharma companies easily achieve Revised Schedule M compliance.

What is Schedule M?

Schedule M is a set of guidelines that pharmaceutical companies in India must abide by. The guidelines have been developed to ensure the highest quality pharmaceutical products are being consistently manufactured in India. It specifies the Good Manufacturing Practices (GMP) for pharmaceuticals being manufactured in India. Schedule M is aimed at improving drug quality, safety, and efficacy as well as the global competitiveness of the Indian pharma market.

6 key benefits of mandatory Schedule M implementation

1. Improved drug quality: Guidelines have been laid down for better quality control measures, thereby leading to production of safe and effective drugs. Manufacturers are required to market drugs only after satisfactory quality test results.
2. Improved patient safety and outcome: Strict quality control regulations mentioned in Schedule M guidelines will reduce the risk of counterfeit and substandard drugs entering the Indian market. Hence, Schedule M guidelines improve patient safety and outcome, thereby protecting public health. 
3. Improved trust and reputation: Compliance with Schedule M guidelines demonstrates the commitment of the pharma company to product quality and patient safety. Thus, Schedule M compliance builds trust among consumers and healthcare professionals.
4. Increased global competitiveness: Schedule M implementation is aimed at ensuring Indian pharma guidelines are at par with global standards. Hence, the Indian pharmaceutical industry will become a reliable supplier of quality medicines, thereby making India a global pharmaceutical manufacturing hub.
5. New business opportunities: By bringing the Indian pharmaceutical industry up to global standards, Schedule M guidelines will open new business avenues and expand its global footprint. 
6. Continuous improvement: Pharma companies will aim to continuously improve their pharmaceutical manufacturing process to deliver highest quality pharmaceutical products.

What is Revised Schedule M?

Significant changes have been made in the existing Schedule M guidelines to safeguard patients and improve the quality of healthcare delivered. Notably, the changes mainly include incorporation of additional requirements in addition to the existing GMP guidelines mentioned in Schedule M. The Revised Schedule M has placed special focus on risk management and qualification and validation of equipment. Furthermore, guidelines for premises, plant, and equipment for manufacturing pharmaceutical products have been introduced. Additionally, the provision for self-inspection has been enhanced. Moreover, the accountability of pharmaceutical manufacturers has been increased.

8 key changes introduced in Revised Schedule M

1. Special emphasis on pharmaceutical manufacturing premises, plant, and equipment
2. Product quality review (PQR)
3. Pharmaceutical quality system (PQS)
4. Quality risk management (QRM)
5. Qualification and validation of equipment
6. Computerised storage system for all products
7. Change control management
8. Product complaint and recall procedure

We understand the challenges commonly faced while complying with the newly implemented Revised Schedule M guidelines. The guidelines are difficult to comprehend and navigate. Hence, we have introduced a comprehensive GMP and Revised Schedule M audit service for pharmaceutical companies. Our audit service will help your pharma company effectively comply with the new Revised Schedule M regulations in a timely and hassle-free manner. As a leading consultant for Revised Schedule M, we will streamline and simplify the compliance process for you.

Pharmadocx Consultants: Comprehensive GMP and Revised Schedule M audit service

Pharmaceutical companies face numerous challenges in achieving and maintaining GMP and Revised Schedule compliance. Failing to meet these guidelines can lead to severe consequences, such as regulatory sanctions, product recalls, market bans, legal actions. Moreover, these will tarnish the company’s reputation in the market. Our GMP and Revised Schedule M audit service will help mitigate these risks and ensure compliance. Having conducted more than 60 GMP and Revised Schedule M audits, we provide the best-in-class service.

Key focus areas of GMP and Revised Schedule M audit service

A GMP and Revised Schedule M audit service performs a thorough evaluation of various components of the pharma manufacturing facility. These audits provide insights into the company’s compliance status and highlight areas of improvement. We have highlighted certain parameters that are specifically analysed.

1. Pharma manufacturing facility and equipment: The audits assess thecleanliness, layout, and design as well as regulatory compliance of the facility. Additionally, the calibration and maintenance status of the manufacturing equipment and machinery are checked.
2. Manufacturing process validation: Validation of the manufacturing and production processes to ensure consistent product quality.
3. Quality system evaluation: The robustness and effectiveness of the quality management systems in place is thoroughly evaluated. The implementation of the standard operating procedures (SOPs) is checked.
4. Supply chain integrity: The compliance of the raw material supplier and contractor with GMP and good distribution practices (GDP) is evaluated.
5. Documentation and record management system: Audits will evaluate batch records, validation reports, and deviation logs. Furthermore, whether the documentation complies with data integrity principles is evaluated. Additionally, the record management system is assessed.
6. Personnel training and qualification: The competency and qualification of the staff are evaluated. Furthermore, the employee training on GMP principles and guidelines is verified. The staff hygiene level and whether the practices meet regulatory standards is assessed.

Why should you opt for our Revised Schedule M audit service?

• Compliance with all clause of Revised Schedule M:  We will identify Revised Schedule M compliance gap sand shortcomings. Then, take proactive steps to ensure compliance with all the clauses.
• Avoid product recalls: Our Revised Schedule M audit service will help you avoid mistakes that usually lead to product recalls. 
• Enhanced operational efficiency: Our audit service will provide insights into your facility’s operational performance. We will identify any inefficiencies, redundancies, and risks. Then, we will help you optimise resource utilisation and avoid disruptions caused by regulatory non-compliances. Furthermore, we will provide suggestions to streamline processes and reduce waste. Moreover, operational improvements will ultimately translate to improved productivity and cost savings.
• Reduced costs and risks: Non-compliance is associated with various expenditures owing to product recalls, fines, and regulatory sanctions. With our support, costs and risks associated with non-compliance can be avoided. 
• Consistent product quality standards: Non-compliance with GMP and Revised Schedule M guidelines can lead to production of substandard drugs. We will validate your pharmaceutical production processes to ensure consistent product quality. Additionally, we will identify risks that could compromise the safety of your products. Furthermore, we will help you implement a robust quality assurance system to avoid quality errors.
• Improved performance: Based on our findings, we will provide suggestions to improve the performance of your manufacturing, quality control, and packaging systems.
• Improved market access: Compliance with GMP and Revised Schedule M guidelines will improve the credibility of your pharma company. Additionally, your products will be at par with global standards. Hence, you will have improved market access.
• Detailed audit report: We prepare in-depth and detailed audit reports highlighting shortcomings and areas of non-compliance. Additionally, we not only identify the lapses but also provide targeted recommendations and actionable next steps for mitigating these issues. Furthermore, we will highlight areas of improvement.

Choose Pharmadocx Consultants’ Schedule M audit service to avoid regulatory hassles

Having more than 27 years of experience, we have helped over 600 clients achieve regulatory excellence. Now it is your turn to achieve Revised Schedule M compliance in a hassle-free manner. We prepare in-depth Schedule M audit service reports highlighting lapses and areas of non-compliance. Additionally, we provide solutions on how to fix the shortcomings and mitigate potential risks. To get your pharmaceutical facility evaluated by industry experts, call/Whatsapp on 9996859227 or email at [email protected].