Management of procedures has always been a challenge in the life sciences cGMP regulated environment and there’s clear requirements specified throughout the regulations and guidance documents for ownership and control of procedures. The following excerpts from 21 CFR 211 illustrate some these requirements.
21CFR 211.22 Responsibilities of the quality control unit
(c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.
(d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.
21CFR 211.100 Written Procedures; Deviations
(a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
(b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.
The last excerpt above indicates the importance of the availability of the current procedure at the time it’s needed during the manufacturing process. In a previous post on Launching Alarm Response Procedures in DeltaV I discussed how Syncade provides the ability to display the current effective procedure within the DeltaV interface. In addition to being able to launch procedures from DeltaV there is a function called Document Kiosk in Syncade Document Control and Archiving.
Kiosk can be accessed from the main Syncade interface at:
http://<servername>/DCA/documentkiosk.aspx.
Generally a human friendly hostname (like “Kiosk” for example) and corresponding IP address are added to the Windows host file in order to direct the user directly to the Document Kiosk URL rather the URL provided above.
Document Kiosk for the production floor provides an easy controlled access to effective documents, which reduces the risk of procedure noncompliance. The Kiosk also frees document management personnel from the rigors and enormous amounts of time spent on issuing and management of controlled document copies within the facility. Multiple SOP binders are no longer necessary on the manufacturing floor and making sure that the right procedure is available becomes a worry of the past.