Last Updated on April 20, 2024 by The Health Master
USFDA Inspection
Strides Pharma Science Limited, a prominent Indian pharmaceutical company focused on developing and manufacturing niche pharmaceutical products, recently announced the results of a routine US Food and Drug Administration inspection (USFDA inspection) at its formulations facility located in Alathur, Chennai.
The inspection, which took place from April 1st to April 5th, 2024, focused on evaluating the company’s adherence to Current Good Manufacturing Practices (cGMP) regulations.
Inspection Findings and Next Steps
The USFDA inspection concluded with two observations noted for Strides Alathur’s formulations facility.
While the specific details of these observations haven’t been publicly disclosed, it’s important to understand that observations are a common outcome of USFDA inspections.
They highlight areas where a manufacturing facility might need to improve its processes or documentation to ensure continued compliance with cGMP regulations.
Strides Pharma Science has assured the public that they will provide a comprehensive response to the USFDA’s observations within the stipulated timeframe.
The company is committed to maintaining the highest quality standards in its manufacturing practices and will work diligently to address the identified areas.
Importance of cGMP Compliance in Pharmaceutical Manufacturing
Current Good Manufacturing Practices (cGMP) are a set of regulations enforced by the USFDA to ensure the quality, safety, and efficacy of drugs manufactured for the US market.
These regulations encompass various aspects of pharmaceutical manufacturing, including:
- Quality control procedures
- Equipment maintenance
- Documentation practices
- Personnel training
- Facilities and environment
Regular USFDA inspections play a crucial role in verifying that pharmaceutical manufacturing facilities comply with these cGMP regulations.
This helps to safeguard public health by minimizing the risk of contamination, errors, or inconsistencies in the production of medications.
Looking Ahead for Strides Pharma Science
Despite receiving two observations, it’s important to remember that such findings are a normal part of the USFDA inspection process. Strides Pharma Science’s prompt response demonstrates their commitment to maintaining cGMP compliance.
The company’s strong track record in developing and manufacturing high-quality pharmaceutical products positions them well to address the USFDA’s observations and continue supplying patients with safe and effective medications.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
USFDA completes inspection at Aurobindo with 3 observations
USFDA issued Form 483 with 6 observations to Cipla
USFDA grants VAI classification to Granules India
USFDA issued Form 483 with 4 observations to Alembic Pharma
Drug recall: Drugs recalled by these Indian Pharma Companies
PCI to conduct GPAT exams on June 8
USFDA approval granted for First Generic Injection for Breast Cancer
CDSCO Seeks More Medical Device Testing Laboratory Registrations
USFDA issues Warning Letter to Natco Pharma for Telangana Plant
USFDA completes inspection at Aurobindo with 3 observations
CDSCO Approval granted for Early Cancer Detection Test
DTAB: Pain Relief Combo Faces New Ban Recommendation
Chemists Association approaches Govt on Discount Pharmacies: Kerala
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:
