Last Updated on October 6, 2024 by The Health Master
PADE inspection at Marksans
A leading pharmaceutical company, Marksans, has made a significant announcement regarding its recent post-marketing adverse drug experience (PADE) inspection conducted by the United States Food and Drug Administration (USFDA).
The inspection, which took place at the company’s Goa, Verna manufacturing facilities, concluded with noteworthy observations.
This development underscores Marksans‘ ongoing commitment to ensuring the safety and quality of its marketed products.
Thorough PADE Inspection
From July 31, 2023, to August 4, 2023, the USFDA conducted a meticulous post-marketing adverse drug experience (PADE) inspection at Marksans‘ Goa, Verna manufacturing facility.
This inspection was geared towards evaluating the company’s practices and procedures related to the reporting of adverse events associated with its marketed products.
The goal was to ensure that any potential issues or concerns were identified and addressed promptly, thus upholding the highest standards of safety and quality.
Observations Arising from Inspection
Following the comprehensive inspection, the USFDA has highlighted two observations.
These observations serve as crucial insights that will guide Marksans in further enhancing its operational protocols and compliance measures.
It’s important to note that observations made by regulatory authorities are valuable opportunities for companies to fine-tune their processes and systems, ultimately resulting in better product safety and patient outcomes.
Commitment to Corrective and Preventive Actions (CAPA)
Marksans is taking a proactive approach in response to the observations made during the PADE inspection.
The company is dedicated to swiftly addressing these observations by developing a comprehensive Corrective and Preventive Action (CAPA) plan.
This plan will outline specific steps and strategies to rectify the identified issues, prevent their recurrence, and bolster the overall quality of its operations.
Also read: NSQ Drug: Route cause analysis and CAPA
Submission to USFDA
The CAPA plan will be meticulously prepared within the stipulated time frame and subsequently submitted to the USFDA.
This submission demonstrates Marksans‘ transparent commitment to collaboration with regulatory authorities and its resolute dedication to continuous improvement.
By submitting a robust CAPA plan, Marksans aims to showcase its accountability and proactive stance in upholding the highest industry standards.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.
NSQ Drug: Route cause analysis and CAPA
Key Notes on Revised Schedule M: Compilation
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
USFDA concludes inspection at Solara with Zero observations: Tamil Nadu
USFDA concludes inspection at Granules Pharma with zero observations
USFDA concludes inspection at Gland Pharma with zero observation
USFDA Warning Letter resolved: Lupin, Goa, Pithampur
USFDA concludes inspection at Eugia Pharma with zero observation
USFDA issues Form 483 with 3 observations to Aurobindo: Hyderabad
32 MSMEs selected for pharma PLI schemes: Govt
Pharma Industry under scrutiny: Key regulatory steps by CDSCO and State Authorities
Drug recall: Lupin Pharma recalled these Birth Control Pills
India became “Aatmanirbhar: in 38 APIs: HM
Pharma Industry seeks faster export of Cough Syrups to Counter China’s Growing Dominance
USFDA issues warning letter to Intas Pharmaceuticals
Tax Dept uncovers Rs 6 Crore Tax Evasion in Pharma Companies: Uttrakhand
Gujarat FDCA takes stringent actions against Non-Compliant Pharma Companies
Major Crackdown: Rs 2 Crore-worth counterfeit drugs seized in Kolkata
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: