SOP – Standard Operating Procedure – are at the basis of any quality management system, independently from the business of the organization. The can be defied as “ set of written instructions that document a routine or repetitive activity followed by an organization”.
Procedures can be used for whatever type of field and business, from quality system to information security, passing through validation activities or other.
SOP are related to regularly recurring processes that need to be conducted within an organization. They are focused to document the modalities by which these activities need to be performed in accordance to quality system requirements and other applicable requirements
The overall goal of procedures, in facts, is to assist the organization to maintain the quality control and quality assurance processes and ensure compliance with all the applicable regulations, that may depend from the business of the organization.
The management of procedures shall be performed through the principles of document control that are at the basis of any quality system. So it is essential that the requirements related to the control of documents are fully respected, not only in relation to revision management but also in relation to the retention period and management of archived versions.
SOP Preparation
Ideally, it would be advantageous to have a procedure in place for determining what processes need to be documented from a procedure standpoint.
Typically, procedures need to be prepared by subject-matter experts who actually perform the work or use the process. In order to be useful, procedures need to be written with sufficient details so that someone with limited experience with or knowledge of the procedure, but with a basic understanding, can successfully reproduce the procedure when unsupervised.
Procedure Review and Approval
It is of fundamental importance that procedures are reviewed by one or more individuals with appropriate training and experience with the process.
The approval may be performed through electronic signature,considering however all the regulatory aspects of these types of signature, such as for example 21 CFR part 11.
When the procedure is approved, it needs to be clearly defined what is the revision of the document, and the publication date of the specific revision.
Overall review of all SOPs
Every change performed of a procedure need to be re-reviewed and re-approved. The systematic review of procedures on a periodic bases (for example every 1 or 2 years) is also a fundamental point, in order to ensure that that the policies and procedures remain current and appropriate, or to determine whether the procedures are even needed.
SOP of SOP
Expecially for Pharma business, it is very important to have what can be called an SOP of SOP. This is basically an SOP describing the management of standard operating procedures, from the their preparation to the approval and review.
Often, this type of procedure describes as well the format of the procedure and exactly what needs to be mentioned in each procedure; this is done in order to avoid discrepancies between multiple procedures.
The contents of the SOP of SOP can be summarised as follows:
- Purpose
- Scope
- Responsibility
- Procedure / Process
- Conclusions
In the section related to the process, different aspects can be described for example:
- General structure
- The template of SOP
- The mandatory field and information
- The management of changes
- The management of deviations from a documented procedure.
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