
Excipient Risk Assessment: Approach, Templates
According to the EU GMP guidance—“Guidance for Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal
Warning letters, 483s, Recalls, Import Alerts, Audit observations
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Popular: Warning Letters, Recalls
Breckenridge Pharmaceutical Inc. has announced the recall of over 360,000 bottles of Duloxetine Delayed-Release Capsules across various strengths in the U.S., citing the detection of Nitrosamine Drug Substance-Related Impurity (NDSRI) above FDA acceptable limits. The drug product is manufactured by...
USFDA has announced the Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program for the second year. It provides opportunity for a limited number of drug manufacturers to participate in the programme to evaluate Quality Management Maturity. CDER will accept...
WHO has published a comprehensive and easy to understand guideline for control of nitrosamines in pharmaceutical products. The TRS 1060 - Annex 2: WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products is applicable for...
According to the EU GMP guidance—“Guidance for Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal
With timelines closing in for drug product manufacturers to finalize their nitrosamine risk assessments, recalls due to Nitrosamine Drug Substance-Related
Authored by: Srinivas Churya This Quality Insight post presents a concise approach for selection and qualification of Inhouse Reference Standards
Authored by: Venkiteswaran.T.K Nitrosamine impurities in pharmaceutical products are a significant concern due to their potential carcinogenicity and the strict
Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with six observations after an audit
Granules India received a warning letter from the USFDA in February 2025. This was along expected lines after significant violations
Please subscribe for latest posts and news with your email address.
Please subscribe for latest posts and news with your email address.
Be informed about current concerns and focus areas of regulators and auditors; Share your views, comments, hear from industry peers….
List your Job Openings with Qvents; Search for profiles matching the jobs requirements; View profiles, Connect with candidates.
Popular: Warning Letters, Recalls
Breckenridge Pharmaceutical Inc. has announced the recall of over 360,000 bottles of Duloxetine Delayed-Release Capsules across various strengths in the U.S., citing the detection of Nitrosamine Drug Substance-Related Impurity (NDSRI) above FDA acceptable limits. The drug product is manufactured by...
USFDA has announced the Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program for the second year. It provides opportunity for a limited number of drug manufacturers to participate in the programme to evaluate Quality Management Maturity. CDER will accept...
Lupin Limited
Lupin Limited
Be informed about current concerns and focus areas of regulators and auditors; Share your views, comments, hear from industry peers….
List your Job Openings with Qvents; Search for profiles matching the jobs requirements; View profiles, Connect with candidates.
Popular: Warning Letters, Recalls
Breckenridge Pharmaceutical Inc. has announced the recall of over 360,000 bottles of Duloxetine Delayed-Release Capsules across various strengths in the U.S., citing the detection of Nitrosamine Drug Substance-Related Impurity (NDSRI) above FDA acceptable limits. The drug product is manufactured by...
USFDA has announced the Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program for the second year. It provides opportunity for a limited number of drug manufacturers to participate in the programme to evaluate Quality Management Maturity. CDER will accept...
Lupin Limited
Lupin Limited
According to the EU GMP guidance—“Guidance for Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal
With timelines closing in for drug product manufacturers to finalize their nitrosamine risk assessments, recalls due to Nitrosamine Drug Substance-Related
Authored by: Srinivas Churya This Quality Insight post presents a concise approach for selection and qualification of Inhouse Reference Standards
Authored by: Venkiteswaran.T.K Nitrosamine impurities in pharmaceutical products are a significant concern due to their potential carcinogenicity and the strict
Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with six observations after an audit
Granules India received a warning letter from the USFDA in February 2025. This was along expected lines after significant violations
Popular: Warning Letters, Recalls
Breckenridge Pharmaceutical Inc. has announced the recall of over 360,000 bottles of Duloxetine Delayed-Release Capsules across various strengths in the U.S., citing the detection of Nitrosamine Drug Substance-Related Impurity (NDSRI) above FDA acceptable limits. The drug product is manufactured by...
USFDA has announced the Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program for the second year. It provides opportunity for a limited number of drug manufacturers to participate in the programme to evaluate Quality Management Maturity. CDER will accept...
WHO has published a comprehensive and easy to understand guideline for control of nitrosamines in pharmaceutical products. The TRS 1060 - Annex 2: WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products is applicable for...