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SOP Review and Approval

SOPs should be reviewed regularly and updated when processes change to ensure they remain useful and accurate. When revising an SOP, only the pertinent section needs to be updated, not the whole document. SOPs should also be reviewed periodically, such as every 1-2 years, to confirm they are still relevant and procedures have not changed. Proper implementation of SOPs includes training users so steps are followed correctly to ensure quality and safety. Management must designate an owner to oversee the SOP system, including eliminating outdated SOPs and measuring the system's performance.

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2K views4 pages

SOP Review and Approval

SOPs should be reviewed regularly and updated when processes change to ensure they remain useful and accurate. When revising an SOP, only the pertinent section needs to be updated, not the whole document. SOPs should also be reviewed periodically, such as every 1-2 years, to confirm they are still relevant and procedures have not changed. Proper implementation of SOPs includes training users so steps are followed correctly to ensure quality and safety. Management must designate an owner to oversee the SOP system, including eliminating outdated SOPs and measuring the system's performance.

Uploaded by

Prince Moni
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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SOP Review and Approval

SOPs should be reviewed by one or more individuals with appropriate training and
experience with the process especially helpful if draft SOPs are actually tested by
individuals other than the original writer before the SOPs are finalized.

A) Frequency of Revisions and Reviews

SOPs need to remain current to be useful. Therefore, whenever procedures are changed,
SOPs should be updated and re-approved. If desired, modify only the pertinent section of
an SOP and indicate the change date/revision number for that section in the Table of
Contents and the document control notation.

SOPs should be also systematically reviewed on a periodic basis, e.g. every 1-2 years, to
ensure that the policies and procedures remain current and appropriate, or to determine
whether the SOPs are even needed. The review date should be added to each SOP that
has been reviewed. If an SOP describes a process that is no longer followed, it should be
withdrawn from the current file and archived

B) Implementing SOP

The most important step for implementing the SOP in working area, train or retrain the
user. Every one should follow the procedure exactly with each and every step in detail, it
is very important to train the user otherwise individual may interpret meaning indifferent
ways.

While training the user trainer should share the reason WHY, SOP must performed
correctly. People are much more to follow when they understand importance of
procedure .Trainer should explain and demonstrate how each step in the SOP will be
performed and should assure them this will increase Quality of product by providing
safety and accuracy which will ultimately increase the confidence of the user.

C) Management of SOP

Organization shall have SOP on Preparation, approval, revision and control of standard
Operating Procedure for better control and management of SOPs. Generally,
administrative aspects of the SOP system such as distribution and filing are well
managed. On the other hand, overall system management, frequently characterized by the
lack of a system owner, is generally poor. If a system owner exists at all, his or her
responsibilities are limited. Ideally a system owner

·Eliminates obsolete SOPs.

·Ensures that SOPs meet their quality requirements and are user friendly.

·Manages SOP change controls.

·Distributes SOPs.

·Ensures that SOPs are current.

·Ensures that new or changed SOPs are valid only after training has occurred and
provides training about the SOP system.

·Measures system performance and periodically reports results to management

·Continuously improves the system.

1. FDA Audit Findings

Code Of Federal Regulations for drug product manufacture’s states (Subpart F, CFR Part
211.100) “There shall be written procedure for production and process control designed
to assure that drug product have the identity, strength, quality and purity, they purport or
are represented to possess.”

The Code of Federal Regulations for medical device manufacturers and other related
regulated entities (Title 21, CFR Part 820) states repeatedly that firms must “establish and
maintain” procedures. To do so, companies should define, document (either on paper or
electronically), and implement standard operating procedures (SOPs). Additionally,
companies must then follow up, review, and revise these documents as needed.

The intent here is simple: Companies must ensure that their organization develops and
manages operationally sound procedures that are compliant with the law. FDA audit
findings in 2006 clearly indicate that ensuring establishment and maintenance of
procedures is fundamental in FDA’s inspection strategy. During inspections in 2006, the
agency commonly observed that companies failed to keep accurate records and that they
neglected to establish and maintain procedures.

2. Conclusion:
SOPs serve as a fundamental means of communication for all levels of the organization.
Not only do they involve employees departmentally, but they also allow management and
employees to gain a cross-functional view of the organization. This approach encourages
employees to think about how process change may affect other functional areas. A good
system forces Employee to think through processes and examine how Procedure might
affect product, personnel, production, and equipment. It shall be noted that the Best
written SOPs will fail if they are not followed.

Annexure of Sample SOP:

Standard Operating Procedure

Company Name and Address: Page No: X of Y

Title : SOP No:

Revision No:

Review Period:

Prepared By Reviewed By Approved By

Objective
Scope

Responsibility

Procedure

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