USFDA
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USFDA
Sathyanarayana M.Sc.
November 14, 2022
What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products?
![Sathyanarayana M.Sc.](http://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpEGiHgao13-NNSAw3snTKCiEIdXQk__fZFY4TBHQlFqmxBPNMiEkat4BC0LsUcOUeYx0q6ayORly_2NFM_7zjfJzDvz_R7bJ_ZTz51qyjZrc2DYH3_wX8Xfup2KXRdLw/w70/Logo.png)
![Does CGMP regulations require three successful process validation batches before a new API or a finished drug product is released for distribution?](https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhyr9bvNFF5_P3_nApDEsXqmH6fjZ_DH8z_enteilYCF6UduqfoPWFbwrrEIxhCsXkERFtUvSVzrRUJ3DeTGEgOpD-oD00Q9rZJ7tIQXG__eLSKIUQS5tcM2PUtzq6t44umH1rc8rXxt96158_E0k5e-BtD1oVeOmEYxFDk9Z499kr2h9worFcIAYW6/w72-h72-p-k-no-nu/process%20validation%20batches%20(1).jpg)
USFDA
Sathyanarayana M.Sc.
November 04, 2022
Does CGMP regulations require three successful process validation batches before a new API or a finished drug product is released for distribution?
![Sathyanarayana M.Sc.](http://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpEGiHgao13-NNSAw3snTKCiEIdXQk__fZFY4TBHQlFqmxBPNMiEkat4BC0LsUcOUeYx0q6ayORly_2NFM_7zjfJzDvz_R7bJ_ZTz51qyjZrc2DYH3_wX8Xfup2KXRdLw/w70/Logo.png)
![FDA Process Validation Guidance 2011: General Principles and Practices](https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhNkC7IWRMuCe4IhtZCfRuLmA4mJG6yTgY83VMqZXs3un834DsXQG2nMoGqUHxR2jQmTlR7ZF4z4Y0iT67nVP5b6nujUhTl9Ah-0T4243oxvJ5H-rXlDwyG-WZ9VSoXhfpwLNawhZQPNQdHBz5zn2AshD87sXrzLX9vdlP5bK_Nojr1bh_hVc4hsRcz/w72-h72-p-k-no-nu/FDA%20(2)%20(1).jpg)
USFDA
Sathyanarayana M.Sc.
November 04, 2022
FDA Process Validation Guidance 2011: General Principles and Practices
![Sathyanarayana M.Sc.](http://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpEGiHgao13-NNSAw3snTKCiEIdXQk__fZFY4TBHQlFqmxBPNMiEkat4BC0LsUcOUeYx0q6ayORly_2NFM_7zjfJzDvz_R7bJ_ZTz51qyjZrc2DYH3_wX8Xfup2KXRdLw/w70/Logo.png)
![Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse?](https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjv6Ts3ldzxFmtaQS9HMVXGE0nqZU8Lk3UPF47hRQ2mBzHvlYVF8hc5KZINfBh3TD8-hG9EDRUyNSXaN4mAnhbDFbQvk1d94WTwhmOfowPFQ3hOCOVLm5QlFcrv_poVBOcnYwtY622W9SN8MV1U2hH1tQS5WRb5emTWHi1YsJPCnHW_IVFT2vk03SDDkeI/w72-h72-p-k-no-nu/warehouse.jpg)
USFDA
Sathyanarayana M.Sc.
September 09, 2022
Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse?
![Sathyanarayana M.Sc.](http://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpEGiHgao13-NNSAw3snTKCiEIdXQk__fZFY4TBHQlFqmxBPNMiEkat4BC0LsUcOUeYx0q6ayORly_2NFM_7zjfJzDvz_R7bJ_ZTz51qyjZrc2DYH3_wX8Xfup2KXRdLw/w70/Logo.png)
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USFDA
Sathyanarayana M.Sc.
September 05, 2022
Do CGMPs require a firm to retain equipment status identification labels with batch record or logs?
![Sathyanarayana M.Sc.](http://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpEGiHgao13-NNSAw3snTKCiEIdXQk__fZFY4TBHQlFqmxBPNMiEkat4BC0LsUcOUeYx0q6ayORly_2NFM_7zjfJzDvz_R7bJ_ZTz51qyjZrc2DYH3_wX8Xfup2KXRdLw/w70/Logo.png)
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USFDA
Sathyanarayana M.Sc.
August 10, 2022
FDA issued warning letters to 3 companies for selling unapproved new drugs
![Sathyanarayana M.Sc.](http://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpEGiHgao13-NNSAw3snTKCiEIdXQk__fZFY4TBHQlFqmxBPNMiEkat4BC0LsUcOUeYx0q6ayORly_2NFM_7zjfJzDvz_R7bJ_ZTz51qyjZrc2DYH3_wX8Xfup2KXRdLw/w70/Logo.png)
![How many titles are there in the FDA CFR (Code of Federal Regulations)?](https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjtckJ0SBZEg37ZdBxfpA02vDETWzFTBWqykApIW3s8scVAAbMYcbbDtEQ0Nwv30eSUtZC5WS1XpokkWLY2Fk59o7ASU3ByWMPJJ25D1K9kjlVoXguHNnROf89BQVZm85AANNOMQLBEsj4-2BRrHKV6BrPSFRJOsEMh9EfFbBvXY4HcUFUuFICHQTokSMI/w72-h72-p-k-no-nu/FDA.jpg)
USFDA
Sathyanarayana M.Sc.
August 07, 2022
How many titles are there in the FDA CFR (Code of Federal Regulations)?
![Sathyanarayana M.Sc.](http://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpEGiHgao13-NNSAw3snTKCiEIdXQk__fZFY4TBHQlFqmxBPNMiEkat4BC0LsUcOUeYx0q6ayORly_2NFM_7zjfJzDvz_R7bJ_ZTz51qyjZrc2DYH3_wX8Xfup2KXRdLw/w70/Logo.png)