Review of FDA Warning Letters to Pharmaceuticals: Cause and Effect Analysis

[...]CGMP rules in essence ensure the safety of a product3. Pareto analysis of poor quality system (Fig 7) revealed that cause of 80% of this category of the observation is due to Inadequate investigation, Role of Quality unit is not defined as required by CFR part 210, SOP not available / Inadequat...

Full description

Saved in:
Bibliographic Details
Published in:Research journal of pharmacy and technology 2018-07, Vol.11 (7), p.3219-3226
Main Authors: Jain, Sanjay Kumar, Jain, Rajesh Kumar
Format: Article
Language:English
Subjects:
Good Manufacturing Practice
Investigations
Manufacturing
Patient safety
Quality standards
Citations: Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
cited_by cdi_FETCH-LOGICAL-c198t-fa22354842245a86daf24ac0d463daad8a9c46f57ba2de5391e3d07b861df6d93
cites
container_end_page 3226
container_issue 7
container_start_page 3219
container_title Research journal of pharmacy and technology
container_volume 11
creator Jain, Sanjay Kumar
Jain, Rajesh Kumar
description [...]CGMP rules in essence ensure the safety of a product3. Pareto analysis of poor quality system (Fig 7) revealed that cause of 80% of this category of the observation is due to Inadequate investigation, Role of Quality unit is not defined as required by CFR part 210, SOP not available / Inadequate SOP, Inadequate stability program testing of finished product not performed and Poor documentation practice. 4.2 DATA INTEGRITY BREACH: Following steps shall be taken to build quality culture in the organization, suggested by senior industry person during the interview - * Emphasis on quality by senior leaders * Increasing employee oversight and empowerment * Reward and recognise quality excellence * Establish environment of Trust and collaboration * Science based decision making His message to other industry friends to ensure compliance and avoid such notices (Warning letter and import alert) were as below - * Do automations to the extent positive to avoid human errors and ensure reproducibility (less variation) of the process * Recruitment of right people, their training and engagement to retain. * Focus about data integrity issues in all the functions like laboratory, production, engineering, warehouse etc. * Facilitate continual improvement * Science based decisions FDA warning letters are available on FDA website as electronic data and can be accessed by anyone. Guidance for Industry, Data Integrity and Compliance With CGM, Draft Guidance, U.S. Department of Health and Human Services Food and Drug Administration, April 2016, Pharmaceutical Quality/Manufacturing Standards (CGMP)
doi_str_mv 10.5958/0974-360X.2018.00592.9
format article
fullrecord <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_2191753631</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2191753631</sourcerecordid><originalsourceid>FETCH-LOGICAL-c198t-fa22354842245a86daf24ac0d463daad8a9c46f57ba2de5391e3d07b861df6d93</originalsourceid><addsrcrecordid>eNo9kF1LwzAUhoMoOOb-ggS8bs13E-_GnB84UETRu3DWJNqxtTNplf17Wyc7N-fAeXh5eRA6pySXRupLYgqRcUXec0aozgmRhuXmCI0Oj-PDTfUpmqS0Iv0oLZnQI_Tw7L8r_4ObgG-up_gNYl3VH3jh29bHhNsGP31C3EDpu7YqYZ2u8Ay65DHUDs9D8GWLpzWsd6lKZ-gk9ISf_O8xer2Zv8zussXj7f1sushKanSbBWCMS6EFY0KCVg4CE1ASJxR3AE6DKYUKslgCc15yQz13pFhqRV1QzvAxutjnbmPz1fnU2lXTxb5EsowaWkiuOO0ptafK2KQUfbDbWG0g7iwldnBnBy12UGQHd_bPnTX8Fy52YPQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2191753631</pqid></control><display><type>article</type><title>Review of FDA Warning Letters to Pharmaceuticals: Cause and Effect Analysis</title><source>Alma/SFX Local Collection</source><creator>Jain, Sanjay Kumar ; Jain, Rajesh Kumar</creator><creatorcontrib>Jain, Sanjay Kumar ; Jain, Rajesh Kumar</creatorcontrib><description>[...]CGMP rules in essence ensure the safety of a product3. Pareto analysis of poor quality system (Fig 7) revealed that cause of 80% of this category of the observation is due to Inadequate investigation, Role of Quality unit is not defined as required by CFR part 210, SOP not available / Inadequate SOP, Inadequate stability program testing of finished product not performed and Poor documentation practice. 4.2 DATA INTEGRITY BREACH: Following steps shall be taken to build quality culture in the organization, suggested by senior industry person during the interview - * Emphasis on quality by senior leaders * Increasing employee oversight and empowerment * Reward and recognise quality excellence * Establish environment of Trust and collaboration * Science based decision making His message to other industry friends to ensure compliance and avoid such notices (Warning letter and import alert) were as below - * Do automations to the extent positive to avoid human errors and ensure reproducibility (less variation) of the process * Recruitment of right people, their training and engagement to retain. * Focus about data integrity issues in all the functions like laboratory, production, engineering, warehouse etc. * Facilitate continual improvement * Science based decisions FDA warning letters are available on FDA website as electronic data and can be accessed by anyone. Guidance for Industry, Data Integrity and Compliance With CGM, Draft Guidance, U.S. Department of Health and Human Services Food and Drug Administration, April 2016, Pharmaceutical Quality/Manufacturing Standards (CGMP)</description><identifier>ISSN: 0974-3618</identifier><identifier>EISSN: 0974-360X</identifier><identifier>EISSN: 0974-306X</identifier><identifier>DOI: 10.5958/0974-360X.2018.00592.9</identifier><language>eng</language><publisher>Raipur: A&amp;V Publications</publisher><subject>Good Manufacturing Practice ; Investigations ; Manufacturing ; Patient safety ; Quality standards</subject><ispartof>Research journal of pharmacy and technology, 2018-07, Vol.11 (7), p.3219-3226</ispartof><rights>Copyright A&amp;V Publications Jul 2018</rights><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c198t-fa22354842245a86daf24ac0d463daad8a9c46f57ba2de5391e3d07b861df6d93</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790,27957,27958</link.rule.ids></links><search><creatorcontrib>Jain, Sanjay Kumar</creatorcontrib><creatorcontrib>Jain, Rajesh Kumar</creatorcontrib><title>Review of FDA Warning Letters to Pharmaceuticals: Cause and Effect Analysis</title><title>Research journal of pharmacy and technology</title><description>[...]CGMP rules in essence ensure the safety of a product3. Pareto analysis of poor quality system (Fig 7) revealed that cause of 80% of this category of the observation is due to Inadequate investigation, Role of Quality unit is not defined as required by CFR part 210, SOP not available / Inadequate SOP, Inadequate stability program testing of finished product not performed and Poor documentation practice. 4.2 DATA INTEGRITY BREACH: Following steps shall be taken to build quality culture in the organization, suggested by senior industry person during the interview - * Emphasis on quality by senior leaders * Increasing employee oversight and empowerment * Reward and recognise quality excellence * Establish environment of Trust and collaboration * Science based decision making His message to other industry friends to ensure compliance and avoid such notices (Warning letter and import alert) were as below - * Do automations to the extent positive to avoid human errors and ensure reproducibility (less variation) of the process * Recruitment of right people, their training and engagement to retain. * Focus about data integrity issues in all the functions like laboratory, production, engineering, warehouse etc. * Facilitate continual improvement * Science based decisions FDA warning letters are available on FDA website as electronic data and can be accessed by anyone. Guidance for Industry, Data Integrity and Compliance With CGM, Draft Guidance, U.S. Department of Health and Human Services Food and Drug Administration, April 2016, Pharmaceutical Quality/Manufacturing Standards (CGMP)</description><subject>Good Manufacturing Practice</subject><subject>Investigations</subject><subject>Manufacturing</subject><subject>Patient safety</subject><subject>Quality standards</subject><issn>0974-3618</issn><issn>0974-360X</issn><issn>0974-306X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><recordid>eNo9kF1LwzAUhoMoOOb-ggS8bs13E-_GnB84UETRu3DWJNqxtTNplf17Wyc7N-fAeXh5eRA6pySXRupLYgqRcUXec0aozgmRhuXmCI0Oj-PDTfUpmqS0Iv0oLZnQI_Tw7L8r_4ObgG-up_gNYl3VH3jh29bHhNsGP31C3EDpu7YqYZ2u8Ay65DHUDs9D8GWLpzWsd6lKZ-gk9ISf_O8xer2Zv8zussXj7f1sushKanSbBWCMS6EFY0KCVg4CE1ASJxR3AE6DKYUKslgCc15yQz13pFhqRV1QzvAxutjnbmPz1fnU2lXTxb5EsowaWkiuOO0ptafK2KQUfbDbWG0g7iwldnBnBy12UGQHd_bPnTX8Fy52YPQ</recordid><startdate>20180701</startdate><enddate>20180701</enddate><creator>Jain, Sanjay Kumar</creator><creator>Jain, Rajesh Kumar</creator><general>A&amp;V Publications</general><scope>AAYXX</scope><scope>CITATION</scope><scope>04Q</scope><scope>04S</scope><scope>04W</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20180701</creationdate><title>Review of FDA Warning Letters to Pharmaceuticals: Cause and Effect Analysis</title><author>Jain, Sanjay Kumar ; Jain, Rajesh Kumar</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c198t-fa22354842245a86daf24ac0d463daad8a9c46f57ba2de5391e3d07b861df6d93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Good Manufacturing Practice</topic><topic>Investigations</topic><topic>Manufacturing</topic><topic>Patient safety</topic><topic>Quality standards</topic><toplevel>online_resources</toplevel><creatorcontrib>Jain, Sanjay Kumar</creatorcontrib><creatorcontrib>Jain, Rajesh Kumar</creatorcontrib><collection>CrossRef</collection><collection>India Database</collection><collection>India Database: Business</collection><collection>India Database: Science &amp; Technology</collection><collection>ProQuest Central (Corporate)</collection><collection>Health &amp; Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><jtitle>Research journal of pharmacy and technology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jain, Sanjay Kumar</au><au>Jain, Rajesh Kumar</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Review of FDA Warning Letters to Pharmaceuticals: Cause and Effect Analysis</atitle><jtitle>Research journal of pharmacy and technology</jtitle><date>2018-07-01</date><risdate>2018</risdate><volume>11</volume><issue>7</issue><spage>3219</spage><epage>3226</epage><pages>3219-3226</pages><issn>0974-3618</issn><eissn>0974-360X</eissn><eissn>0974-306X</eissn><abstract>[...]CGMP rules in essence ensure the safety of a product3. Pareto analysis of poor quality system (Fig 7) revealed that cause of 80% of this category of the observation is due to Inadequate investigation, Role of Quality unit is not defined as required by CFR part 210, SOP not available / Inadequate SOP, Inadequate stability program testing of finished product not performed and Poor documentation practice. 4.2 DATA INTEGRITY BREACH: Following steps shall be taken to build quality culture in the organization, suggested by senior industry person during the interview - * Emphasis on quality by senior leaders * Increasing employee oversight and empowerment * Reward and recognise quality excellence * Establish environment of Trust and collaboration * Science based decision making His message to other industry friends to ensure compliance and avoid such notices (Warning letter and import alert) were as below - * Do automations to the extent positive to avoid human errors and ensure reproducibility (less variation) of the process * Recruitment of right people, their training and engagement to retain. * Focus about data integrity issues in all the functions like laboratory, production, engineering, warehouse etc. * Facilitate continual improvement * Science based decisions FDA warning letters are available on FDA website as electronic data and can be accessed by anyone. Guidance for Industry, Data Integrity and Compliance With CGM, Draft Guidance, U.S. Department of Health and Human Services Food and Drug Administration, April 2016, Pharmaceutical Quality/Manufacturing Standards (CGMP)</abstract><cop>Raipur</cop><pub>A&amp;V Publications</pub><doi>10.5958/0974-360X.2018.00592.9</doi><tpages>8</tpages></addata></record>
fulltext fulltext
identifier ISSN: 0974-3618
ispartof Research journal of pharmacy and technology, 2018-07, Vol.11 (7), p.3219-3226
issn 0974-3618
0974-360X
0974-306X
language eng
recordid cdi_proquest_journals_2191753631
source Alma/SFX Local Collection
subjects Good Manufacturing Practice
Investigations
Manufacturing
Patient safety
Quality standards
title Review of FDA Warning Letters to Pharmaceuticals: Cause and Effect Analysis
url http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-09-21T10%3A51%3A50IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Review%20of%20FDA%20Warning%20Letters%20to%20Pharmaceuticals:%20Cause%20and%20Effect%20Analysis&rft.jtitle=Research%20journal%20of%20pharmacy%20and%20technology&rft.au=Jain,%20Sanjay%20Kumar&rft.date=2018-07-01&rft.volume=11&rft.issue=7&rft.spage=3219&rft.epage=3226&rft.pages=3219-3226&rft.issn=0974-3618&rft.eissn=0974-360X&rft_id=info:doi/10.5958/0974-360X.2018.00592.9&rft_dat=%3Cproquest_cross%3E2191753631%3C/proquest_cross%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c198t-fa22354842245a86daf24ac0d463daad8a9c46f57ba2de5391e3d07b861df6d93%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2191753631&rft_id=info:pmid/&rfr_iscdi=true