Documentation Supporting CGXP Compliance
A core part of an organization’s Quality Management System (QMS) is the documentation hierarchy that guides the practices necessary to consistently produce quality products. Policies and procedures form the backbone of this documentation hierarchy, so it is important to develop and implement clearly written policies and procedures that are in line with the organization’s quality policy and all internal and external requirements.
A policy is typically considered a guiding principle used to set direction in an organization. A procedure is typically considered a series of steps to be followed as a consistent and repetitive approach to accomplish an end result. For each policy that requires action by employees within the organization, there is an accompanying procedure that describes the specific steps for how to apply the policy. Policies and procedures should be adaptable to the needs of the organization and enforced across all functions. These documents must also be controlled such that changes or exceptions are not made without proper approval.
Policies and procedures need to be accessible to employees at all times. Some organizations develop manuals or handbooks to provide to employees. Others may keep the information in a validated electronic system accessible by computer.
Policy and procedure owners are held accountable for the timely review, updating, and distribution of this information to reflect changing internal or external requirements. For regulated industries, such as pharmaceuticals, biological products, and medical devices, personnel training is required on all relevant policies and procedures, depending on job function. Personnel training is therefore intimately linked to policy and procedure changes, because employees must be aware of any changes to the organization’s practices to carry out their work in a compliant manner.
Skilled resources and quality expertise are not always available within each organization to understand the regulatory requirements for developing and implementing a compliant set of policies and procedures. Kymanox has broad expertise in establishing and implementing efficient, effective, and sustainable policies and procedures that fit within your overall QMS in order to meet the satisfaction of internal and external stakeholders.
Proven past performance from Kymanox includes, but is not limited to, the following:
- Quality Manual development and overhaul
- Entire Quality Management System (QMS) development, both paper-based and electronic
- Base templates for all policies, Standard Operating Procedures (SOPs), and forms
- Equipment and clean utility procedures
- Batch record development
- CAPA and investigations, all aspects
- Training systems, including training content
LINK TO: GOOD DOC PRACTICES, CGMP, and QMS.