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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Sun Pharma Recalls Testosterone
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<blockquote data-quote="madman" data-source="post: 243063" data-attributes="member: 13851"><p>2023!</p><p></p><p>[URL unfurl="true"]https://www.raps.org/news-and-articles/news-articles/2023/1/fda-cites-sun-pharma-with-litany-of-gmp-violations[/URL]</p><p></p><p></p><p>[URL unfurl="true"]https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-12152022[/URL]</p><p></p><p><strong>3. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).</strong></p><p><strong></strong></p><p><strong><em>You failed to identify and use equipment suitable for the filling of your viscous parenteral drug product. Inappropriately designed vial filling equipment led to substantial extraneous matter contamination in testosterone cypionate injection 200 mg/mL, 1 ml vials.</em></strong> Further, your production department failed to establish adequate personnel practices and supervisory oversight to prevent the use of damaged equipment.</p><p></p><p><strong><em>You determined the design of the filling equipment ((b)(4)) in combination with the viscous nature of your drug product-generated friction. This friction caused an abrasive effect on the surface of (b)(4) during (b)(4) movement which introduced blackish fine metallic particles into your vial during filling. You explained that these (b)(4) could not be fixed once damaged. Although reportedly removed from service, the damaged (b)(4) were listed as approved equipment in your master manufacturing batch record approved on April 5, 2022, approximately two years after they were identified as the root cause for cross-contamination.</em></strong></p><p></p><p><em><strong>Notably, one of the damaged (b)(4) (H102) was used to fill numerous batches of testosterone cypionate injection.</strong></em></p><p></p><p>It is your responsibility to ensure that only appropriately designed and maintained equipment are used in the manufacture of your drug products.</p><p></p><p><strong><em>We acknowledge that after our inspection you voluntarily recalled five marketed testosterone cypionate injection lots associated with the (b)(4) investigations.</em></strong></p><p><strong><em></em></strong></p><p><strong><em>Your response is inadequate. Your response fails to address the flaws in your change management system that permitted continued use of damaged and inappropriately designed (b)(4). Your response states that damaged (b)(4) were isolated and not used in filling testosterone cypionate injection but were inadvertently not removed from the manufacturing batch record. You also state that an associated (b)(4) (H102) was reconditioned and was acceptable for use. However, your firm indicated during the inspection that these damaged (b)(4) could not be reconditioned and acknowledged that they were not suitably designed. Your response also did not include a risk assessment that thoroughly evaluates the design and lifecycle control of manufacturing equipment including (b)(4) and (b)(4).</em></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>In response to this letter, provide:</strong></p><p></p><ul> <li data-xf-list-type="ul">Your CAPA plan to implement routine, vigilant operations management oversight (corporate and local) of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, appropriately qualified production management personnel, and improved systems for ongoing management review. Your plan should also ensure that appropriate actions are taken throughout the company network.</li> <li data-xf-list-type="ul">A thorough evaluation and risk assessment that addresses the suitability of your equipment for its intended use. You should include a determination of whether equipment is of appropriate design and a robust program for ongoing control and maintenance. Also describe how Quality Assurance will oversee the efficacy of systems used by operations to accomplish these critical objectives.</li> <li data-xf-list-type="ul">An independent retrospective review of your manufacturing batch records to ensure that defective <strong>(b)(4)</strong> manufactured by <strong>(b)(4)</strong> or <strong>(b)(4)</strong> were not used during filling operations.</li> <li data-xf-list-type="ul">An independent retrospective review of all complaints, including the associated investigations, for discoloration and particulates, for sterile drug products within expiry as of the date of this letter. Include the drug product name, batch number, and date of manufacture, line number, along with a summary of the complaint, description of likely root cause(s), CAPA plan, and status of CAPA.</li> <li data-xf-list-type="ul">An independent, comprehensive review of your complaint system that identifies deficiencies in the system and corresponding CAPA that are needed.</li> <li data-xf-list-type="ul">A comprehensive, independent assessment of your change management system. This assessment should include, but not be limited to, your procedure(s) to ensure changes are appropriately justified, evaluated, and reviewed to a final determination of acceptability by your QU. Your change management program should include provisions for determining change effectiveness.</li> </ul></blockquote><p></p>
[QUOTE="madman, post: 243063, member: 13851"] 2023! [URL unfurl="true"]https://www.raps.org/news-and-articles/news-articles/2023/1/fda-cites-sun-pharma-with-litany-of-gmp-violations[/URL] [URL unfurl="true"]https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-12152022[/URL] [B]3. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63). [I]You failed to identify and use equipment suitable for the filling of your viscous parenteral drug product. Inappropriately designed vial filling equipment led to substantial extraneous matter contamination in testosterone cypionate injection 200 mg/mL, 1 ml vials.[/I][/B] Further, your production department failed to establish adequate personnel practices and supervisory oversight to prevent the use of damaged equipment. [B][I]You determined the design of the filling equipment ((b)(4)) in combination with the viscous nature of your drug product-generated friction. This friction caused an abrasive effect on the surface of (b)(4) during (b)(4) movement which introduced blackish fine metallic particles into your vial during filling. You explained that these (b)(4) could not be fixed once damaged. Although reportedly removed from service, the damaged (b)(4) were listed as approved equipment in your master manufacturing batch record approved on April 5, 2022, approximately two years after they were identified as the root cause for cross-contamination.[/I][/B] [I][B]Notably, one of the damaged (b)(4) (H102) was used to fill numerous batches of testosterone cypionate injection.[/B][/I] It is your responsibility to ensure that only appropriately designed and maintained equipment are used in the manufacture of your drug products. [B][I]We acknowledge that after our inspection you voluntarily recalled five marketed testosterone cypionate injection lots associated with the (b)(4) investigations. Your response is inadequate. Your response fails to address the flaws in your change management system that permitted continued use of damaged and inappropriately designed (b)(4). Your response states that damaged (b)(4) were isolated and not used in filling testosterone cypionate injection but were inadvertently not removed from the manufacturing batch record. You also state that an associated (b)(4) (H102) was reconditioned and was acceptable for use. However, your firm indicated during the inspection that these damaged (b)(4) could not be reconditioned and acknowledged that they were not suitably designed. Your response also did not include a risk assessment that thoroughly evaluates the design and lifecycle control of manufacturing equipment including (b)(4) and (b)(4).[/I] In response to this letter, provide:[/B] [LIST] [*]Your CAPA plan to implement routine, vigilant operations management oversight (corporate and local) of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, appropriately qualified production management personnel, and improved systems for ongoing management review. Your plan should also ensure that appropriate actions are taken throughout the company network. [*]A thorough evaluation and risk assessment that addresses the suitability of your equipment for its intended use. You should include a determination of whether equipment is of appropriate design and a robust program for ongoing control and maintenance. Also describe how Quality Assurance will oversee the efficacy of systems used by operations to accomplish these critical objectives. [*]An independent retrospective review of your manufacturing batch records to ensure that defective [B](b)(4)[/B] manufactured by [B](b)(4)[/B] or [B](b)(4)[/B] were not used during filling operations. [*]An independent retrospective review of all complaints, including the associated investigations, for discoloration and particulates, for sterile drug products within expiry as of the date of this letter. Include the drug product name, batch number, and date of manufacture, line number, along with a summary of the complaint, description of likely root cause(s), CAPA plan, and status of CAPA. [*]An independent, comprehensive review of your complaint system that identifies deficiencies in the system and corresponding CAPA that are needed. [*]A comprehensive, independent assessment of your change management system. This assessment should include, but not be limited to, your procedure(s) to ensure changes are appropriately justified, evaluated, and reviewed to a final determination of acceptability by your QU. Your change management program should include provisions for determining change effectiveness. [/LIST] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Sun Pharma Recalls Testosterone
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