Return-Path: Received: from smtpclient.apple ([75.115.210.159]) by smtp.gmail.com with ESMTPSA id 956f58d0204a3-64996105c96sm1922232d50.23.2026.01.28.22.30.42 for (version=TLS1_2 cipher=ECDHE-ECDSA-AES128-GCM-SHA256 bits=128/128); Wed, 28 Jan 2026 22:30:42 -0800 (PST) From: TJ Bourdeau Content-Type: multipart/alternative; boundary="Apple-Mail=_DBA9151C-8982-4B19-AB0D-9D119FB9EB0F" Mime-Version: 1.0 (Mac OS X Mail 16.0 \(3864.300.41.1.7\)) Subject: Aseptic Experience Message-Id: Date: Thu, 29 Jan 2026 01:30:31 -0500 To: Joyce Barreto X-Mailer: Apple Mail (2.3864.300.41.1.7) --Apple-Mail=_DBA9151C-8982-4B19-AB0D-9D119FB9EB0F Content-Transfer-Encoding: quoted-printable Content-Type: text/plain; charset=utf-8 Joyce, Below is my response to your text sent on 01/28/26: At Formulated Solutions, I=E2=80=99ve supported GMP manufacturing = operations for approximately 3+ years, with direct involvement in = quality oversight of controlled environment and aseptic-adjacent = manufacturing, including nasal spray production lines. My experience includes on-floor Quality support of manufacturing = operations conducted in controlled environments where we required the = dawning and doffing of =E2=80=9Cbunny suit=E2=80=9D gowning, where I = provided IPQA and FPQA oversight during active production runs. While I = was not an aseptic operator, I was responsible for ensuring aseptic = technique, procedural adherence, and documentation accuracy were = maintained throughout manufacturing activities. This included line = clearance verification, batch record review, real-time documentation = support, and escalation of quality concerns during production. As I progressed into Quality Supervisor and then QA Manager roles, my = responsibilities expanded to include review and approval of batch = records associated with aseptic/controlled-environment steps, deviation = investigations related to aseptic practices or documentation errors, and = CAPA implementation to strengthen right-first-time execution. I also = supported inspection readiness and participated in FDA and customer = audit shadowing, including on-floor support and follow-up documentation. Overall, my aseptic manufacturing experience is rooted in quality = governance and oversight of nasal spray manufacturing performed under = GMP-controlled environments, with a strong focus on compliance, = documentation integrity, and risk-based decision-making during live = production. Let me know if you need anything else from me,=20 TJ= --Apple-Mail=_DBA9151C-8982-4B19-AB0D-9D119FB9EB0F Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset=utf-8

Joyce,

Below is my = response to your text sent on 01/28/26:

At = Formulated Solutions, I=E2=80=99ve supported GMP manufacturing = operations for approximately 3+ years, with direct involvement in = quality oversight of controlled environment and aseptic-adjacent = manufacturing, including nasal spray production = lines.

My = experience includes on-floor Quality support of manufacturing operations = conducted in controlled environments where we required the dawning and = doffing of =E2=80=9Cbunny suit=E2=80=9D gowning, where I provided IPQA = and FPQA oversight during active production runs. While I was not an = aseptic operator, I was responsible for ensuring aseptic technique, = procedural adherence, and documentation accuracy were maintained = throughout manufacturing activities. This included line clearance = verification, batch record review, real-time documentation support, and = escalation of quality concerns during = production.

As I = progressed into Quality Supervisor and then QA Manager roles, my = responsibilities expanded to include review and approval of batch = records associated with aseptic/controlled-environment steps, deviation = investigations related to aseptic practices or documentation errors, and = CAPA implementation to strengthen right-first-time execution. I also = supported inspection readiness and participated in FDA and customer = audit shadowing, including on-floor support and follow-up = documentation.

Overall, my aseptic manufacturing experience = is rooted in quality governance and oversight of nasal spray = manufacturing performed under GMP-controlled environments, with a strong = focus on compliance, documentation integrity, and risk-based = decision-making during live production.

Let me know if you = need anything else from me,

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