Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
- Key Notes on Revised Schedule M: Point No. 8 – Change Control - December 15, 2024
- Forms: All types for Hospital RMI - December 14, 2024
- Key Notes on Revised Schedule M: Point No. 7 – Product Recall - December 14, 2024
Last Updated on December 16, 2024 by The Health Master
Qualification and validation
Key considerations for Point No. 5 – Qualification and validation compliance under revised Schedule M are outlined below.
Continued from: Key Notes on Revised Schedule M: Point No. 4 – Sanitation and Hygiene
Qualification and validation
To comply with Good Manufacturing Practices (GMP), pharmaceutical manufacturers must:
Identify and Document Qualification and Validation Requirements:
- Determine the specific qualification and validation activities necessary to control critical aspects of their operations.
- Develop and document a comprehensive validation master plan outlining the key elements of their qualification and validation program.
Establish and Document Qualification and Validation:
- Design Qualification (DQ): Ensure that premises, utilities, equipment, and processes are designed according to GMP requirements.
- Installation Qualification (IQ): Verify that premises, utilities, and equipment are built and installed in compliance with design specifications.
- Operational Qualification (OQ): Confirm that premises, utilities, and equipment operate as intended according to design specifications.
- Process Validation (PV) or Performance Qualification (PQ): Demonstrate that a specific process consistently produces a product meeting predefined specifications and quality attributes.
Must read article: Understanding DQ, IQ, OQ, and PQ in the Pharma Industry
Validate Significant Changes:
- Qualify and validate any changes to premises, facilities, equipment, or processes that may impact product quality, directly or indirectly.
Maintain Ongoing Validation:
- Establish a continuous validation program to review and update validation activities periodically.
- Document the commitment to maintaining validation status in relevant company documents.
Assign Validation Responsibilities:
- Clearly define responsibilities for performing validation activities.
Conduct Validations According to Protocols:
- Perform validation studies in accordance with predefined and approved protocols.
- Prepare and store written reports summarizing results and conclusions.
Establish Processes and Procedures Based on Validation Results:
- Develop and implement processes and procedures based on the outcomes of validation studies.
Prioritize Validation of Critical Areas:
- Pay particular attention to the validation of analytical test methods, automated systems, and cleaning procedures.
Ensure Comprehensive Qualification and Validation:
- Conduct qualification and validation for premises, equipment, process systems, and facilities.
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Next: Key Notes on Revised Schedule M: Point No. 6 – Complaints and adverse reaction
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
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
