Pharmaceutical Outsourcing Q3 2023 - 23

CONTRACT MANUFACTURING
SECTION TITLE
and efficiently. Policies provide the framework for decision-making
within the company, while work instructions are needed to ensure
that tasks are completed in accordance with established standards.
To ensure that these documents remain up-to-date and reflective of
current regulations and best practices, they should be reviewed every
two to three years by document owners and in collaboration with QA
personnel. In doing so, companies can be sure that their QMS is upto-date
and compliant with industry regulations.
3. Does the CAPA and/or investigation
procedure give a step-by-step
description of how to conduct rootcause
analysis while identifying effective
CAPAs, and assess the impact on
products and processes consistently in
every investigation?
Without a clear understanding of how well their QMS is functioning,
companies can miss out on identifying and correcting issues that could
be impacting product quality or processes. Corrective and preventive
action (CAPA) procedures are an important tool for evaluating the
health of a company's QMS as they must provide clear guidance on
how to conduct root cause analysis, identify effective CAPAs, and
assess the impact on products and processes consistently in every
investigation. It is also essential that the procedures are adequately
reviewed, approved by senior management, and regularly evaluated
for effectiveness.
By providing step-by-step instructions for conducting root cause
analysis, CAPA helps ensure investigations are conducted consistently
and effectively. They also allow companies to identify corrective
actions that will prevent similar issues from occurring in the future, as
well as assess any potential impact on products and processes. With
these tools in place, companies can more easily evaluate their QMS
and take steps to improve it where necessary. This can be a critical
factor in ensuring quality control is maintained across a company's
products and processes.
4. Is a Quality Management Review
conducted periodically, involving senior
management, and does that review result
in continuous improvement?
Finally, it is important to establish a quality management review
process
that
is
conducted
periodically
and
involves
senior
management. This ensures that the company's QMS is regularly
evaluated for effectiveness and improvement. The results of this
periodic review should be used to identify areas for improvement,
ensure processes are up-to-date and compliant with regulations, and
ensure that employees are trained and knowledgeable.
This review helps to ensure that all necessary measures are
taken to ensure compliance and continuous improvement in the
organization's quality management system. QMRs are conducted
periodically-typically quarterly, though this may vary based
on the size and scope of an organization-and they help to keep
organizations in line with current regulations and best practices. The
goal of these reviews is to identify any areas that need improvement
or need to be updated so that corrective action can be taken if
needed. Senior management is often involved in these reviews,
as they have a vested interest in keeping the QMS up to date and
ensuring that processes are being carried out properly. Through
its periodic review process, an organization's QMS should benefit
from continuous improvement because it helps identify any areas
that need to be addressed. The result is a better quality of products,
services, and customer satisfaction.
By asking these four questions, companies can gain a better
understanding of the health of their QMS. This can help them identify
areas for improvement and make sure they are adequately prepared
for inspections.
Michelle Anastasi is Director, Quality Management & Compliance,
US, PharmaLex, where she serves as the international service
lead for GxP Quality Management Systems including eQMS /
eDMS. Michelle has more than 20 years of industry experience in
quality management and GMP.
pharmoutsourcing.com | 23 | July/August/September 2023
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Pharmaceutical Outsourcing Q3 2023

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