Pharmaceutical Outsourcing Q3 2023 - 22

CONTRACT MANUFACTURING
Four Questions to Determine the
Health of Your Company's QMS
Michelle Anastasi
Director of Quality and Compliance
PharmaLex US
According to the American Society for Quality, a quality management
system (QMS) is a " formalized system that documents processes,
procedures, and responsibilities for achieving quality policies and
objectives. " For companies in life sciences and pharmaceuticals,
maintaining a healthy QMS is crucial for ensuring compliance and
adequate preparation for inspections. If you're unsure whether
your current QMS is hitting the mark, ask yourself the following four
questions to identify if your processes adequately help you maintain
compliance and quality control.
1. Does the company have a Quality Policy
and/or Quality Manual, approved by
senior/executive management, and issued
within the past three years?
A Quality Policy and Quality Manual are essential for establishing
a consistent set of processes, procedures, and responsibilities for
achieving quality objectives. A quality policy should outline the
company's commitment to meeting customer requirements and
should be reviewed at least once every three years. It is also important
to ensure that the quality manual contains all relevant information
related to quality management, such as procedures, processes, and
responsibility matrixes, which align with regulatory requirements.
This policy and manual should outline the company's commitment
to quality and expectations regarding day-to-day operations. The
purpose of this document is to ensure that all employees understand
the company's commitment to quality and comply with industry
standards and regulations. Furthermore, it is important to ensure that
the policy and manual are regularly reviewed for compliance at least
every two to three years to reflect any changes within the organization
over this period of time. In this way, companies can be confident that
they are upholding their commitment to quality in all aspects of their
operations. Additionally, having it approved by senior and executive
management ensures that they are aware of the company's stance
on quality and they have taken responsibility for its implementation.
2. Are all controlled documents (SOPs,
policies, work instructions, etc.) reviewed
every two to three years by document
owners in collaboration with quality
assurance personnel?
In addition to the quality policy and manual, it is important to review all
controlled documents (SOPs, policies, work instructions, etc.) at least
once every two or three years. This should be done in collaboration
between the document owners and quality assurance personnel to
ensure that the documents reflect changes in regulations, customer
requirements, and processes. It is important to ensure that all SOPs
are up-to-date, relevant, and fit for purpose; that policies and work
instructions are reviewed and updated when necessary; and that any
new process or system is documented appropriately.
Controlled documents, such as SOPs, policies, and work instructions,
are important components of a company's QMS. These documents
serve to provide guidance and direction to staff on how processes
should be conducted. For example, SOPs provide detailed
information on the steps necessary to complete a process accurately
Pharmaceutical Outsourcing | 22 | July/August/September 2023
Pharmaceutical Outsourcing Q3 2023

Table of Contents for the Digital Edition of Pharmaceutical Outsourcing Q3 2023
