Common Review Observations During Periodic Revision of SOPS

Quality documentation role in any organization hold high importance as they drive the role of writing new documents, periodic revision and maintaining GDP compliance. Receiving FDA observations on structure, content and approval process of standard operating procedure can be insulting and time consuming. In this article I have populated most common observation a company can receive form FDA and all other inspection authorities associated with Standard operating procedures.

I remember one of the quality consulting guru has told me that “Nobody knows your process better than you do” so make the most of your knowledge and write a SOP in such a way even your grandmother understand. Further he mention that every internal audit is an opportunity o find our regulatory GAPs and fix with a proud feeling. Rather than waiting for FDA some day and bringing your attention toward what they found in our practices.

With reference to the same I have populated few common observations sited during regulatory authorities’ inspections, customer audits, supplier audits and self-audits on SOP compliance.


Scope of SOP has become wider.


Editorial changes-Not summarized effectively


Need to make SOP in line with current updates in GMP guidelines or forthcoming guidelines.


Improvements in language of SOP for better clarity


Elaborate SOP instructions for better clarity and based on experiences of persons while following those SOPs


Improvements based on need of compliance to current GMP trends as well as internal and external audits


Change in SOP format


Change in SOP and format numbering system


Need to revise attached formats in SOP attachments to meet current documentation requirements.


Removal of less significant instructions to reduce confusions or ambiguity.

Most of the above observations can be omitted if effective document writing, reviewing and approving practices have been adopted in companies. For example having an automated ERP document management system ( Electronic Document management System) provide process visibility, maintain the discipline, bring attention of users toward their roles and prohibit approval of documents with proper and complete information.

However having EDMS can be expensive for all companies in life science world due to financial challenges. Therefore I recommend utilizing Source Consulting FDA complied standard operating procedures for Quality Documentation, Training and Risk management. These SOP are designed while keeping FDA minimum requirements in mind and can be changed or upgraded as per your company need. Feel free to down load complete suite of Sop’s from Source website and link mention below.

Click here for Free SOP

27th Sept 2017