Compass Health SOP: Labelling and Packaging

Study Notes

This document outlines the Standard Operating Procedure (SOP) for Compass Health relating to labelling and packaging of medical devices.
The SOP applies to finished medical devices manufactured by Compass for sale in Canada and the USA, also including investigational medical devices.
The SOP is intended to adhere to relevant standards and regulations like FDA QSR, CMDR, Australian TG(MDR), ISO 13485, and ISO 15223.
The document specifies various roles (Author, Approver, QA/RA, COO, Head of Product) and their respective responsibilities.
Tenzin Yangzom, James Baskin, and Rushabh Gudka are shown as approving personnel.
The SOP's version 1.0 was initially released on January 3, 2024.

The SOP references other documents within the QMS (Quality Management System) like SOP: Control of Records, Product Development, Production, Purchasing, Verification of Purchased Product, Control of Non-Conforming Product.
The SOP also references specific work instructions (WI).
The document introduces Acronyms like DMRI (Device Master Record Index), used to link to relevant labelling and packaging specifications.

QA/RA is responsible for periodically spot-checking labelling activities.
Operations personnel are designated to handle packaging activities.
Marketing is responsible for developing and validating marketing materials (labelling).
Engineering is responsible for creating packaging (dielines) and electronic labelling.
Different roles and responsibilities within the company are clearly outlined in the SOP.

Product packaging and labelling are integral parts of Compass' medical device production and distribution.
The product is not fully complete until labelling and packaging are applied, following specific quality management system procedures to ensure compliance with product specifications.
Control of processes for labels and packaging ensures quality by having personnel training, process validation, work instructions, and monitoring.

Specific information needs to be included on the labelling and the packaging, such as manufacturer's name/address, device details, contents, batch code, usage dates, storage conditions, warnings/precautions, sterile markings, unique device identifiers, and usage instructions.
This information may also be provided electronically, maintained for 5 years after the last device is manufactured.
If the intended purpose or intended user is not obvious, Compass must clearly state it in the instructions for use.
The labelling and packaging procedures are crucial for ensuring product safety and compliance.

The received labelling/packaging materials must be inspected for compliance with the specifications regarding materials and printing, using proper control numbers.
The Product Storage area is dedicated to ensure proper and safe storage of accepted labels and packaging materials.
The inspection information is recorded.

User manuals and other documents must be in English for devices sold in Canada, Australia, the USA.
Translations may be provided in other languages on request.

QA-RA personnel regularly monitor packaging operations to check for compliance with specifications.
This includes checking artwork prototypes, documentation of inspection, and packaging operations.

Records are maintained for purchase and receiving, labelling/packaging inspection, and labelling/packaging specifications.
These records contain details of the activities and results of inspections and validation processes.