Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on January 20, 2025 by The Health Master
Sex Hormones
Key considerations for Hazardous Substances Such as Sex Hormones, Steroids (Anabolic, Androgenic) or Cytotoxic Substances for compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: Sterile products
Key points on specific requirements for Manufacture of Hazardous Substances Such as:
- Sex Hormones,
- Steroids (Anabolic, Androgenic) or
- Cytotoxic Substances.
Good Manufacturing Practices for Pharmaceutical Products
This detailed breakdown provides a comprehensive overview of the requirements for:
Hazardous Substances Such as Sex Hormones, Steroids (Anabolic, Androgenic) or Cytotoxic Substances outlined in Schedule M.
Here’s a breakdown of what pharmaceutical manufacturers must do to comply with the above regulations, presented pointwise:
Requirements
Facilities shall be designed and operated in accordance with Good Manufacturing Practice (GMP) principles to:
- Ensure product quality
- Protect operators from harmful effects of hazardous substances
- Protect the environment from contamination
Production of certain hazardous substances shall be conducted in separate, dedicated facilities.
These facilities may be in the same building as another facility but must be separated by a physical barrier and have separate entrances, staff facilities, and air handling systems.
The extent of separation from adjacent facilities and the sharing of common services shall be determined by a risk assessment.
Manufacturing facilities shall be regarded as containment facilities.
The effective operation of a facility may require a combination of some or all of the following:
- Appropriate facility design and layout
- Manufacturing process controls
- Properly designed Environmental Control Systems (ECS) or HVAC
- Extraction systems
- Personal Protective Equipment (PPE)
- Decontamination procedures
- Industrial hygiene (monitoring staff exposure levels)
- Medical surveillance (monitoring staff exposure levels)
- Administrative controls
Risk Assessment
Not all products containing hazardous substances are equally potent, and risk assessments shall be carried out to determine the potential hazards to operators and the environment.
The risk assessment shall also determine which phases of the product production and control cycle, from manufacture of the API to distribution of the finished product, would fall under the requirements of these guidelines.
Risk assessments applicable to the environment shall include airborne contamination as well as liquid effluent contamination.
The design and operation of the facility shall follow the guidelines if the risk assessment determines that the products or materials being handled pose a risk to the operators, the public, or the environment.
The toxicological data available, such as permissible occupational exposure levels (OEL) for the product, shall be taken into account when conducting the risk assessment.
The risk assessment shall take into account occupational health and safety requirements for OELs in the work environment.
Product Protection
The requirements for producing quality products, with respect to protection from contamination and cross-contamination, clean room class of air, temperature, and humidity shall be the same as for other pharmaceutical products.
Personal Protective Equipment and Breathing Air Systems
The fundamental design principle for a facility and its production equipment is to provide product containment and operator protection.
If the facility and equipment design is not providing adequate product containment, operator protection shall be provided.
If facility and equipment design are adequate, a spillage or non-routine incident could cause a hazardous situation, in which case PPE shall be available.
Unless otherwise specified in the material safety data sheet, operators shall be protected from exposure with an appropriate method, such as by wearing:
- Flash-spun, high-density polyethylene fibre material suits or impervious washable protective suits.
- Integral hoods may be required depending on the respirator type used.
- Flash-spun, high-density polyethylene fibre material shoes, lower leg covers, or cleanable boots.
- Suitable single-use, disposable gloves.
- Double gloves shall be worn where direct active contact with the product cannot be avoided.
- Gloves shall be taped or sealed on to the protective suit sleeves.
- Respirator eye and face protection with associated breathing air systems.
Where breathing air systems are used, these shall be provided to supply safe breathing air to the operators to prevent them from inhaling air from within the facility.
Personnel shall be appropriately trained and assessed in the use of these systems before they enter the area.
The breathing air systems shall comprise a protective face mask, which shall form an integral part of a protective suit.
The breathing air systems could be any of the following:
- A central air supply system which connects to the operator’s facemask by means of flexible hoses and quick coupling sockets, also called an Airline Respirator (AR).
- The air connection shall incorporate a one-way air system to prevent contaminated air entering the face mask during connection or disconnection.
- The air supply shall be treated to ensure a temperature and level of humidity that are comfortable for the operator.
- The air source could be a high-pressure fan or an air compressor.
- If an air compressor is used, it shall be of the oil-free type or have suitable oil removal filters fitted.
- A Self-Contained Breathing Apparatus (SCBA) or Powered Air Purifying Respirator (PAPR) that is securely attached to the operator’s belt and connects to the operator’s face mask.
- This system draws air from the room in which the operator is working and the air supply is delivered to the face mask by means of a battery-driven fan. The AR provides superior protection.
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 Dahiya, SDCO cum Licensing Authority, FDA Haryana
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