Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
- Key Notes on Revised Schedule M: Point No. 13 – Equipment - December 24, 2024
- Forms: For Homoeopathy Medicines - December 22, 2024
- Key Notes on Revised Schedule M: Point No. 12 – Premises - December 22, 2024
Last Updated on December 24, 2024 by The Health Master
Equipment
Key considerations for Point No. 13 – Equipment compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: Point No. 12 – Premises
To ensure compliance with Good Manufacturing Practices (GMP) for pharmaceutical products, manufacturers must adhere to the following principles regarding Equipment:
Equipment Requirements for Pharmaceutical Manufacturers
To comply with Good Manufacturing Practices (GMP) for pharmaceutical products, manufacturers must adhere to the following equipment-related principles:
Design and Installation:
- Equipment should be designed and installed to minimize errors and contamination risks.
- The layout should facilitate effective cleaning and maintenance.
Piping and Connections:
- Fixed pipework must be clearly labeled to indicate contents and flow direction.
- Service pipework and devices should be adequately marked.
- Non-interchangeable connections or adapters must be used for hazardous substances.
Measurement Equipment:
Balances and other measuring equipment should be:
- Of appropriate range and precision.
- Calibrated regularly.
Cleaning and Maintenance:
- Production equipment should be cleaned according to a fixed schedule.
- Laboratory equipment and instruments should be suitable for testing procedures.
- Washing, cleaning, and drying equipment should not be a source of contamination.
Product Quality:
- Production equipment should not pose a hazard to products.
- Equipment parts in contact with products should be non-reactive, non-additive, and non-absorptive.
Defective Equipment:
- Defective equipment must be removed from production and QC areas or clearly labeled.
Minimizing Contamination:
- Closed equipment should be used whenever possible.
- When open equipment is used, precautions should be taken to minimize contamination.
Cross-Contamination Prevention:
- Non-dedicated equipment should be cleaned according to validated procedures between different product runs.
Documentation:
- Current drawings of critical equipment and support systems must be maintained.
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Next: Key Notes on Revised Schedule M: Point No. 14 – Materials ….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
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