Key Notes on Revised Schedule M: Radiopharmaceutical Products

The manufacturing of radiopharmaceutical products must follow the core principles of GMP, which are mentioned in Part I of Schedule M.

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Key Notes on Revised Schedule M: Radiopharmaceutical Products
Revised Schedule M: Radiopharmaceutical Products
Rakesh Dahiya

Last Updated on January 20, 2025 by The Health Master

Radiopharmaceutical Products

Key considerations for Radiopharmaceutical Products for compliance under revised Schedule M are outlined below.

Continued from: Key Notes on Revised Schedule M: Site Master File

Good Manufacturing Practices for Pharmaceutical Products

Revised Schedule M: Essential GMP Guidelines for Radiopharmaceutical poducts Manufacturers in India

Specific Good Manufacturing Practices (GMP) requirements have been mentioned in the revised Schedule M for the manufacturing of radiopharmaceutical products.

The aim of these guidelines is to ensure the quality, safety, and efficacy of these radiopharmaceutical products.

Key Points:

GMP Principles:

  • The manufacturing of radiopharmaceutical products must follow the core principles of GMP, which are mentioned in Part I of Schedule M.
  • It is very important to follow GMP as the shelf-lives of many radiopharmaceuticals are evry short, often necessitating retrospective quality control.

Personnel:

  • The manufacturing process of radiopharmaceutical products must be under the personal supervision of a qualified technical staff who has expertise in radiopharmacy and radiation hygiene.
  • These technical staff must undergo rigorous health checks and gain training in GMP, handling radioactive materials, and radiation safety.
  • All the records regarding the training of technical staff must be maintained clearly and reviewed regularly.

Premises and Equipment:

  • To ensure radiation protection, cleanliness, and sterility, the manufacturing facilities must be designed accordingly.
  • Dedicated facilities and equipment must be provided for the handling of these radioactive materials and for processing the sterile products.
  • Specially designed ventilation systems must be provided to prevent the contamination and protect the technical staff from radiation exposure.

Manufacturing Processes:

  • Standard Operating Procedures (SOPs) must be prepared and followed for all manufacturing activities in the facility.
  • Starting materials must be tested and evaluated, which must meet all the quality specifications.
  • Calibration and maintenance of all the critical equipment must be done regularly to get accurate test results.

Labelling and Packaging:

  • Proper and clear labeling must be done on the radiopharmaceutical products, having all the essential details, e.g., name of the drug, radionuclide, name of manufacturer, radioactivity, and expiry date of the product.
  • Packaging of the radiopharmaceutical products must be done according to the transport regulations.
  • All leaflets having information for the patients must be provided with instructions of use, method for preparation, dosage, and all safety precautions.

Production and Distribution Records:

  • All records pertaining to the manufacturing, testing, and distribution activities of radiopharmaceutical products must be maintained.
  • Separate records must be maintained for receipt, storage, use, and disposal of radiopharmaceutical products.

Quality Control & Quality Assurance:

  • A proper quality assurance system is must to ensure the quality, safety, and efficacy of radiopharmaceutical products.
  • Quality control activities, i.e., testing of starting materials, intermediate products, and finished products, must be done properly.
  • Samples of radiopharmaceutical products must be retained for testing and analysis in the future to access the quality and efficacy.

Please note: This information is for general guidance only and may not be exhaustive. Refer to the official regulations and any applicable guidance documents for specific requirements and interpretations.


Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana


Next: Key Notes on Revised Schedule M: Phytopharmaceuticals ….coming soon

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