How are batches managed?
Paper Batch Records
All pharmaceutical batches are utilized to document such items as raw material lots used, equipment utilized, temperatures, mixing times, operators, etc. These items are required to be tracked and documented for every pharmaceutical batch as part of the Code of Federal Regulations 21 part 188.
Generally, paper batch records have been utilized for pharmaceutical production. The issue with the utilization of paper batch records is the possibility of human error during documentations. Some of these human errors are production calculation, write overs, missing data, and missing initial and dates.
After a batch is completed the record will go to quality for review. In quality, a review will be completed to ensure that the Correct lots were used, all data calculations were performed correctly, and Good Documentation Practices (GDP) were properly followed. Depending on the facilities documentation procedures and the documentation error, the amount of time a Lot is held could be lengthy. Lots can not be released until batch records are closed. With paper batch records, and depending on the issues found, this could take weeks to rectify and release the batch. With the utilization of an electronic batch record, time and resources will be saved and the Lot will get to market faster.
Electronic Batch Records
The new and growing form of batch recording is Electronic Batch Record, also known as Manufacturing Execution System (MES). This form of batch record is not limited to just new production facilities. These electronic records could be limited to the maintenance department or to a single production line.
Many existing sites are moving to Electronic Batch Records for their robust capability to close out Lots. These systems will include the capability to communicate with installed equipment such as scales, autoclaves, SIP, CIP, COP, filling equipment, etc. With these integrations, equipment calculation and system processes can be performed without the aid or involvement of human participation. This greatly removes the likelihood of human error and possibility of miscalculation of material addition, mixing time, temperature adjustment, etc.
How CAI Can Help
Our Experience
At CAI, we have participated in many integrations of various paper batch record systems, batch record upgrades, and MES integrations into new and existing sites. One of our best-known work would be at a large bulk and filling manufacture located near Atlanta, GA. CAI supported the integration of the client’s Siemens EBM system at a brand new, state of the art facility. CAI assisted with the integration, educating operators on the functionality and use of the system, and validation support of the MES software.
At the beginning of the project our team beta tested the system based on preliminary designs of the batch record. With several iterations and operator interaction with the system, we were able to fine tune and create a highly functional system that limited the chance of operator input error while also optimizing batch record flow. With the action of beta testing the MES software, we were able to determine the best process flow as determined by the software designers, operations engineering, and Quality departments while also maintaining up to date system process flows and software design specification that were integral in final validation of the system.
With CAI you are not limited to just the final validation of your batch record systems. We can assist in your design to better batch processing and human performance, maintenance, operator training, and integration of your chosen batch record system.
Want more info on MES? Click here to download our whitepaper on the Costs & Benefits.
Definitions
| Word | Definition |
| Batch | a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture |
| Lot | a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits |
| SIP | Steam In-Place |
| CIP | Clean In-Place |
| COP | Clean Out of Place |
About the Author:
Michael (michael.morrison@cagents.com)is a engineering professional with experience in pharmaceuticals and software engineering. His experience includes performing software and hardware modifications for a major pharmaceutical company’s assembly and packaging line. He also supported a large installation of a process system, performing Pipe and instrument verification along with process functionality testing. He was instrumental on the validation efforts of a new Autoinjector assembly and packaging line.
References:
United states code of Federal regulations: 21CFR210.3 and 21CFR211.188