Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
- Forms: For Homoeopathy Medicines - December 22, 2024
- Key Notes on Revised Schedule M: Point No. 12 – Premises - December 22, 2024
- Key Notes on Revised Schedule M: Point No. 11 – Personnel - December 21, 2024
Last Updated on December 22, 2024 by The Health Master
Premises
Key considerations for Point No. 12 – Premises compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: Point No. 11 – Personnel
To ensure compliance with Good Manufacturing Practices (GMP) for pharmaceutical products, manufacturers must adhere to the following principles regarding premises:
Premises Design and Maintenance:
Suitability:
Premises must be designed, constructed, and maintained to suit the specific operations, adhering to local regulations like the Factories Act.
Minimizing Risk:
The layout should minimize the risk of errors and facilitate effective cleaning to prevent cross-contamination and product quality issues.
Dust Control:
Measures must be in place to control dust generation and prevent cross-contamination during processes like sampling, weighing, and packaging.
Environmental Protection:
The premises should be located in an environment that minimizes contamination risks.
Sanitation:
Finished product manufacturing areas must be designed for good sanitation.
Maintenance:
Regular maintenance should not compromise product quality.
Cleaning and Disinfection:
Detailed written procedures must be followed for cleaning and disinfection, with records maintained.
Utilities:
Electrical supply, lighting, temperature, humidity, and ventilation should be appropriate and not adversely affect product quality or equipment function.
HVAC Systems:
HVAC systems must be designed, installed, qualified, and maintained to appropriate standards.
Pest Control:
Effective measures must be in place to prevent the entry of pests like insects, birds, and rodents.
Logical Flow:
The premises should be designed to ensure a logical flow of materials and personnel.
Ancillary Areas:
Segregation:
Rest and refreshment rooms, changing facilities, and maintenance workshops should be separate from production and control areas.
Animal Houses:
Animal houses must be well-isolated with separate access and air-handling facilities.
Storage Areas:
Capacity and Segregation:
Sufficient storage capacity should be available for various categories of materials and products, with proper separation and segregation.
Storage Conditions:
Storage areas must be clean, dry, well-lit, and maintained within acceptable temperature and humidity limits.
Receiving and Dispatch:
Receiving and dispatch areas should be separate and protected from the weather.
Quarantine:
Quarantine areas must be clearly marked and access restricted to authorized personnel.
Segregation:
Separate storage should be provided for rejected, recalled, or returned materials or products.
Hazardous Materials:
Highly active, radioactive, narcotic, and dangerous substances must be stored securely.
Packaging Materials:
Printed packaging materials must be stored safely and securely.
Sampling Areas:
Separate sampling areas should be provided for starting materials.
Weighing Areas:
Segregation:
Weighing of starting materials and yield estimation should be carried out in separate, dust-controlled areas.
Production Areas:
Segregation:
Dedicated facilities may be required for highly sensitizing or biological products to minimize cross-contamination risks.
Logical Layout:
Production areas should be laid out logically to minimize the risk of confusion and cross-contamination.
Adequate Space:
Sufficient space should be available for orderly positioning of equipment and materials.
Surface Finish:
Interior surfaces should be smooth, non-shedding, and easily cleanable.
Services:
Pipework, light fittings, ventilation points, and other services should be designed to avoid hard-to-clean areas.
Drainage:
Drains should be adequately sized and designed to prevent backflow.
Ventilation:
Effective ventilation with air filtration and control of temperature and humidity should be provided.
Packaging Areas:
Packaging areas should be designed to avoid mix-ups and contamination.
Lighting:
Adequate lighting should be provided, especially for visual inspections.
Quality Control (QC) Areas:
Segregation:
QC laboratories should be separate from production areas. Biological, microbiological, and radioisotope testing areas should be further segregated.
Design and Space:
QC laboratories should be designed to suit the operations, with sufficient space for samples, reference standards, reagents, and records.
Ventilation:
Separate air supply and air-handling units may be required for QC laboratories.
Instrument Rooms:
Separate rooms may be needed for instruments to protect them from external factors.
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Next: Key Notes on Revised Schedule M: Point No. 13 – Equipment ….coming soon
Key Notes on Revised Schedule M: Must read
Important short notes for Industry and Regulators
CDSCO Guidelines on Drug Recall
Quality Assurance Vs Quality Control in the Pharma Industry
Major FDA audit findings about Equipment and Instruments
Understanding GMP, cGMP, and WHO-GMP
Quality Assurance in the Pharmaceutical Industry
Duties and responsibilities of QA person in Pharma Industry
Difference: Disintegration and Dissolution test in pharma industry
Understanding DQ, IQ, PQ, and OQ in the Pharma Industry
Licensing procedure for manufacturing of Drugs
Procedure to obtain license for manufacturing of Cosmetics
Procedure to obtain license for manufacturing of Homoeopathic Medicines
Procedure to obtain license for manufacturing of Medical Devices
Procedure to obtain License to Manufacture drugs for testing and analysis purposes
Procedure to obtain license for Blood Centre (Blood Bank)
Procedure to obtain license for Commercial Testing Laboratories
Procedure to obtain license for Medical Store / Pharmacy
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