I wanted to share my guest post published at the CPhI Pharma Evolution website. There are some great comments, so join in if the post sparks some ideas.
Stringent inspection-readiness policies are common with pharmaceutical and biotech manufacturers. From a computerized system standpoint, the rules of Part 11 (Electronic Records; Electronic Signatures – Scope and Application) and Good Automated Manufacturing Practice (GAMP) are well established and considered. These manufacturers must be able to answer the question, “Is my computer system ready for FDA inspection?”
Heather Schwalje, a senior life sciences industry consultant at Emerson Process Management, tells us that the US Food and Drug Administration maintains technical inspection guides and training aids.
The following focus on computerized systems:
- ITG No. 23 – Inspection Technical Guide) – The Computer in FDA Regulated Industries
- ITG No. 28 – Evaluation of Production Cleaning Processes for Electronic Medical Devices – Part III, Methods
- Training Aid – Computerized Systems in Drug Establishments
These guidance documents were written in the late 1970s and early 1980s, but they have been maintained with updates, most recently in 2009.
In ITG No. 23, the notion of “defined problems” is something to which the computerized systems are designed to react, Heather explains. Operations staff must automate “negative paths” or deviation documentation while in active production, but, when designing electronic batch records, manufacturers cannot possibly define every issue that might come up during the manufacture of a batch.
For atypical deviations, one of the biggest challenges with electronic batch records is the fact that one cannot simply comment in the margins, as one can with traditional paper records. If an issue comes up that is not accounted for in pre-defined automated sequences, you will need to have appropriate documentation procedures in place, and also specify which function keystrokes will be required for commenting.
In cases of aborted batches, you will also need a procedure for reconciling electronic records, to ensure that all related items are left in their appropriate operational states. An example may be automatic updates of equipment status and electronic logbooks. If you force an aborted batch through to the end without performing corrective steps, the equipment could be left in an “in-use” state and not be cleaned appropriately in preparation for future batches.
For typical deviations that may occur during production that also have typical response mechanisms, issue resolution may align across the plant if it is automated. Even though you cannot predefine all the issues that may arise, you can predefine mitigation and resolution activities with regard to your electronic batch record integrity.
Likely, a few instances exist where, during electronic batch record redesign, you can actually anticipate typical problems. Limiting the response to a single instruction path has advantages and disadvantages. This fixed response provides consistency, but may constrain operators and supervisors from exercising the kind of flexibility that may be required to get production back on the right track.
Also, if operations personnel do not routinely exercise these fixed instructions to typical problems, they may not be familiar or comfortable with the instruction paths presented in the electronic batch record. Training is critical to avoid problems with developing predefined problem pathways. In addition, these pathways should be designed simply, to help ensure success with these automated instructions.
In order to ensure that your facility and IT are ready for an inspection, Heather suggests that you review your “defined” problems and ensure, in cases when that path is used, that no additional problems are encountered. If you did find problems, did the investigation determine the most appropriate corrective and preventive actions to fix the path?
If you are planning to attend the June 11-13 ISPE cGMP conference in Baltimore, Md., make sure to catch up with Heather for her thoughts on ways to improve inspection readiness.