
Continuous Process Verification (CPV) and Evaluation Templates
Author: Venkiteswaran.T.K The USFDA’s 2011 guidance on process validation advocates a life cycle approach and defines process validation activities in
Warning letters, 483s, Recalls, Import Alerts, Audit observations
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Popular: Warning Letters, Recalls
The Drugs Technical Advisory Board (DTAB) in India has recommended for amendment of Drug Rules for suspension of Product License of drugs declared Not of Standard Quality (NSQ) by a Government Testing Laboratory. In its 92nd meeting held on 24...
Indian drug regulator CDSCO (Central Drugs Standards Control Organisation) has published the Not of Standard Quality (NSQ) drugs list for March 2025. CDSCO has published two lists - one for the NSQ Alerts reported by the Central / CDSCO laboratories...
Cronus Pharma LLC on behalf of Cronus Pharma Specialties, Hyderabad, India initiated a recall of Dexmedetomidine Hydrochloride Injection 0.5 mg/mL due to particulates matter in the product. Two lots of the product, Dexased (Aspen Veterinary Resources, LTD) & DexmedVet (Cronus...
Author: Venkiteswaran.T.K The USFDA’s 2011 guidance on process validation advocates a life cycle approach and defines process validation activities in
In March 2025, Glenmark initiated recall of 23 products (148 lots) in US for cGMP deviations. The recall cover a
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
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
The Drugs Technical Advisory Board (DTAB) in India has recommended for amendment of Drug Rules for suspension of Product License of drugs declared Not of Standard Quality (NSQ) by a Government Testing Laboratory. In its 92nd meeting held on 24...
Indian drug regulator CDSCO (Central Drugs Standards Control Organisation) has published the Not of Standard Quality (NSQ) drugs list for March 2025. CDSCO has published two lists - one for the NSQ Alerts reported by the Central / CDSCO laboratories...
Syngene
Sun Pharmaceutical Industries Ltd
Sun Pharmaceutical Industries Ltd
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
The Drugs Technical Advisory Board (DTAB) in India has recommended for amendment of Drug Rules for suspension of Product License of drugs declared Not of Standard Quality (NSQ) by a Government Testing Laboratory. In its 92nd meeting held on 24...
Indian drug regulator CDSCO (Central Drugs Standards Control Organisation) has published the Not of Standard Quality (NSQ) drugs list for March 2025. CDSCO has published two lists - one for the NSQ Alerts reported by the Central / CDSCO laboratories...
Syngene
Sun Pharmaceutical Industries Ltd
Sun Pharmaceutical Industries Ltd
Author: Venkiteswaran.T.K The USFDA’s 2011 guidance on process validation advocates a life cycle approach and defines process validation activities in
In March 2025, Glenmark initiated recall of 23 products (148 lots) in US for cGMP deviations. The recall cover a
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
Popular: Warning Letters, Recalls
The Drugs Technical Advisory Board (DTAB) in India has recommended for amendment of Drug Rules for suspension of Product License of drugs declared Not of Standard Quality (NSQ) by a Government Testing Laboratory. In its 92nd meeting held on 24...
Indian drug regulator CDSCO (Central Drugs Standards Control Organisation) has published the Not of Standard Quality (NSQ) drugs list for March 2025. CDSCO has published two lists - one for the NSQ Alerts reported by the Central / CDSCO laboratories...
Cronus Pharma LLC on behalf of Cronus Pharma Specialties, Hyderabad, India initiated a recall of Dexmedetomidine Hydrochloride Injection 0.5 mg/mL due to particulates matter in the product. Two lots of the product, Dexased (Aspen Veterinary Resources, LTD) & DexmedVet (Cronus...