Key Notes on Revised Schedule M: Point No. 3 – Good Manufacturing Practice (GMP)

Pharmaceutical manufacturers must adhere to these guidelines to ensure Good Manufacturing Practice (GMP) and produce high-quality drugs.

Rakesh Dahiya

December 7, 2024

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Rakesh Dahiya

SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com

Good Manufacturing Practice

Key considerations for Point No. 3 – Good Manufacturing Practice for Pharmaceutical Products compliance under revised Schedule M are outlined below.

Continued from: Key Notes on Revised Schedule M: Point No. 2 – Quality Risk Management

Good Manufacturing Practice for Pharmaceutical Products

Pharmaceutical manufacturers must adhere to these guidelines to ensure Good Manufacturing Practice (GMP) and produce high-quality drugs.

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Key Principles:

Quality Assurance: Implement a robust quality management system to ensure consistent production and control of products according to established quality standards.
Risk Management: Identify, assess, and minimize risks associated with pharmaceutical manufacturing processes to safeguard product quality, safety, and efficacy.

Specific Requirements:

Process Definition and Review:

Clearly define manufacturing processes, conduct regular reviews, and ensure they are capable of consistently producing products that meet specifications.

Qualification and Validation:

Perform necessary qualification and validation activities to verify the suitability of equipment, systems, and processes.

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Resource Provision:

Allocate adequate resources, including:

Qualified and trained personnel
Suitable premises and space
Appropriate equipment and services
Quality materials, containers, and labels
Approved procedures and instructions
Proper storage and transport facilities
Sufficient personnel, laboratories, and equipment for in-process control
Relevant records and documentation

Clear and Specific Procedures:

Develop clear and unambiguous procedures tailored to the specific facilities and operations.

Correct Execution and Training:

Ensure that procedures are followed correctly and that personnel are adequately trained.

Record Keeping:

Maintain comprehensive records to document all manufacturing steps, deviations, investigations, and corrective actions.

Traceability:

Establish a system to track the complete history of each batch of product.

Storage and Distribution:

Implement proper storage and distribution practices to minimize quality risks.

Recall System:

Have a system in place to recall products from the market if necessary.

Complaint Handling:

Investigate product complaints, identify root causes, and take corrective actions to prevent recurrence.

Regulatory Compliance:

Adhere to all relevant regulatory requirements, including the Drugs and Cosmetics Act, 1940, Drugs Rules, 1945, Indian Pharmacopoeia, and other applicable guidelines.

Read or Download Revised Schedule M

Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana

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Next: Key Notes on Revised Schedule M: Point No. 4 – Sanitation and Hygiene

Click below links for more articles on Revised Schedule M

Schedule M

Gist of 31 Chapters on Schedule M

Revised Schedule M Guidelines: Drug Recall and Ensuring Pharma Quality

Pharmaceutical Quality: Key Amendments in Revised Schedule M

Revised Schedule M: The Role of Pharmaceutical Waste Management

Guidance documents for industry

Key Notes on Revised Schedule M: Must read