HANDLING OF POTENT MOLECULES (CATEGORY-IV)

OBJECTIVE:

To lay down the handling procedure of potent molecules (Category-IV).

SCOPE:

This SOP is applicable to the handling procedure of potent molecules (Category-IV).

RESPONSIBILITY:

Initiator Officer/Designee: Production shall perform the operation activity as per SOP.

Initiator Executive/Designee: Production shall ensure the compliance of the SOP.

ACCOUNTABILITY:

QA Head shall be Accountable for implementation of SOP.

ABOUT POTENT MOLECULE:

Potent molecules in pharmaceuticals refer to highly active compounds that elicit significant biological effects at low doses. These molecules are integral to drug development, particularly for targeted therapies like cancer treatments, immunomodulators, and hormonal agents. Their high potency enables smaller dosages, reducing potential side effects and improving patient compliance. However, their powerful nature demands stringent handling protocols during manufacturing to ensure safety for workers and prevent cross-contamination. Advanced technologies, such as high-containment facilities and closed-system operations, are critical in processing these compounds. The rise of potent molecules underscores the shift toward precision medicine, focusing on efficacy and tailored patient care.

PROCEDURE:

Adequate precautions to be taken for personnel protection while handling potent molecules from dispensing to packing stage.

From dispensing to primary packing activity PAPR, Jupiter mask and 3M mask should be used to avoid/minimize the inhalation.

Tyvek (full body disposable suit) must be used from dispensing to primary packing stage.

Gloves and goggles should be used to carry out the all manufacturing activity from dispensing to packing.

Re useable PAPR items need to be de dusted and cleaned with dry lint free cloth before usage.

From storage of API to Primary packing the potent molecules should be stored in segregated area which is free from dust.

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Operational facility require, Close operations with split butterfly valve (Sifting, Milling, RMG, Compression) with Local Exhaust/Point Exhaust ventilation.

The cleaning of the process equipments and accessories should be done as per the cleaning validation specific to product/ matrix.

All the Personnel protective equipment of single time use such as Jupiter mask/3M mask, Tyvek (full body disposable suit), gloves to be discarded after each and every use.

Only Male employees are allowed to handle the product at any point of mfg. process & packaging, exception would be for secondary where there is no open product exposure.

Note:

• Female and pregnant women are not allowed to work, analysis/In process quality testing as the drug may cause birth defects and the developing fetus as per MSDS.
• Potent molecules are limited toxic drug substance and potential teratogen and limited carcinogen in humans.
• If required, we may have to take scan the operating personnel blood / serum levels for the active ingredient exposure level at Pre and Post exposure of process / operations.

REFERENCES:

Not Applicable

ANNEXURES: 

Not Applicable

ENCLOSURES: SOP Training Record.

DISTRIBUTION:

• Controlled Copy No. 01  :          Head Quality Assurance
• Controlled Copy No. 02  :         Head Production
• Master Copy                    :          Quality Assurance Department

ABBREVIATIONS:

REVISION HISTORY:             

CHANGE HISTORY LOG

Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/handiling-of-potent-molecules-category-iv/