When it comes to the pharmaceutical industry, maintaining compliance with FDA regulations is essential to ensure the safety of consumers and to prevent the risk of receiving a warning letter from the FDA. Maintaining compliance and avoiding FDA warning letters need an understanding of the significance of document control. Four document control best practices are covered in this article to help you avoid receiving an FDA warning notice.
1. Implementing Document Control methods or procedures
Every document should be accompanied with:
Revision history: For any record, you should have the option to see when it was given, when it was modified, reason of change and who made which changes.
Document recall: When a new report supplements an old one, organization should document retrieval procedure of all the old copies.
Document Safeguards: What controls do you have set up to keep individuals from erasing or adjusting records? Authorizations should be set up that keep unapproved people from changing key records, for example, SOPs, particulars and testing techniques.
2. Incorporate Document Control with change control process
Documents are essential to every cycle, from change management to employee training, Any adjustment in one of these areas should trigger an assessment of existing documents, so that when you make an important revisions are done in the documents then its related employee training should be triggered.
3. Incorporating Data Integrity in Documents
The Auditing/Regulatory agencies expects data to be attributable, legible, and complete, an original or true copy and accurate (ALCOA). ALCOA has been introduced by FDA while ALCOA+ concept has been introduced by European MHRA.
While the FDA’s draft guidance introduced the concept of ALCOA, or data needing to be Attributable, Legible, Contemporaneous, Original, and Accurate, the MHRA guidance references “ALCOA+” which includes the additional concepts of the data being Complete, Consistent, Enduring and Available.
4. Control Paper Records
Accessibility and availability to blank paper formats for raw/source data recording should be appropriately controlled and monitored. All blank formats issued by quality assurance department should be appropriately numbered and should have format number and should be monitored by issuance register.
Use of controlled books with numbered pages, may be necessary to prevent the re-creation of a record; while retaining incomplete forms and recording why they were replaced.
After reading this blog, we hope you can understand the importance documentation errors and properly use the proposed checklist and improve on it further.
Now that you know this:- hopefully you are in position to answer the Assignment(s)
What are ALCOA Principles? Are your departments documentation practices incorporated on ALCOA Principles?
Do your documentation practices involve Change control procedures for change/revision/updating of documents?
Do your documentation practices involve timely review and updating of documents such as SOPs, STP?
Do QA department provide proper and timely training to employees after relevant documents’ such as SOP, STP are revised?
Have you found any loose sheets/blank sheets in uncontrolled manner in your lab? Please immediately report to concerned manager?
Have you found any books for documentation in uncontrolled manner in your lab? Please immediately report to concerned manager?
