Writing SOPs for quality management system
The DOCLINX team provides services for writing Standard Operating Procedures (SOPs) for the quality management system of pharmaceutical companies.
What are the requirements for the quality management system?
According to legislation, the quality system of pharmaceutical enterprises must be fully documented, and its effectiveness must be subject to constant monitoring and analysis. All personnel actions related to the quality system must be described in detail in the corresponding written procedures.
Proper documentation is an integral part of the quality system. Its main objectives are: preventing errors arising from verbal communication, and tracking individual operations in the process of drug distribution.
Special attention should be paid to the use of up-to-date and officially approved procedures. The name and purpose of each document must be clearly indicated. It is necessary to regularly review and update documents, while applying version control. It is important to implement a system that prevents the accidental use of outdated versions. Documents that have become invalid should be withdrawn from circulation and archived.
When are SOPs checked?
The presence of SOPs in your company is checked in the following cases:
- Passing the Roszdravnadzor inspection
- Undergoing a preventive visit from Roszdravnadzor
- Undergoing an audit from the head office
- Undergoing a client audit
Most in-demand SOPs
Here is a list of the most in-demand SOPs that the DOCLINX team is ready to develop for your company:
- SOP on SOPs
- Documentation management
- Document storage (archiving)
- Training
- Corrective and preventive actions
- Deviation management
- Complaint management
- Conducting self-inspections
- Supplier qualification and approval
- Supplier audits
- Reception
- Shipment
- Storage
- Transportation
- Product statuses (quarantine, defect, free circulation)
- Validation of computerized systems
- Temperature monitoring
- Introduction into civil circulation
- Work in the MDLP
- Product destruction
Personalized commercial offer
To receive a personalized commercial offer corresponding to the specifics of your situation, follow the appropriate link and answer a few questions — Link to survey
Contact DOCLINX and be confident in your quality management system.