| Regulated change control (i.e. change control | | | | departments may be involved in the management of |
| enforced by the FDA, ISO, etc.) may appear to be | | | | proposed changes. R&D will be especially |
| the control of only one type of change. In other | | | | involved in the review and approval of proposed |
| words many professionals may mistake change | | | | changes within the manufacturing environment and |
| control to be the control of unexpected changes as | | | | other R&D professionals may also play a part in |
| life science research and manufacturing processes | | | | managing proposed changes to non-clinical laboratory |
| progress and move forward. This idea however, | | | | studies or clinical research studies. |
| though essentially true, is only a partial "chunk" of the | | | | Planned Changes |
| change types with which a change control system | | | | When careful planning of future studies or |
| should be equipped to manage. Unexpected changes, | | | | manufacturing processes occur, there are often a |
| as deviations or nonconformances, should | | | | small myriad of planned changes that can be |
| undoubtedly be documented, controlled and analyzed | | | | predicted. These changes may result from the |
| but two other types of change should be considered | | | | proposed changes already mentioned in this article. |
| as well in a large array of highly regulated | | | | These will be the proposed changes that have |
| environments. | | | | already been tested, accepted and are planned for |
| Proposed Changes | | | | action. These changes may seem like they are |
| Depending on the industry in question, proposed | | | | essentially "wrapped up" but in all reality they are |
| changes may be those changes suggested by | | | | changes that require the coverage of additional (and |
| management, the quality department, manufacturing, | | | | carefully designed) tasks documented within the |
| etc. Other companies may allow all employees to | | | | company's change control SOPs and procedures. For |
| propose changes or in other words file change | | | | example, the article Change Control: Best Practices |
| control requests. Regardless of the type of proposed | | | | for FDA-Compliant Medical Device Manufacturers also |
| changes that are filed many regulated companies | | | | states the following: |
| must adhere to specific processes in order to | | | | "It is common sense that change control covers |
| manage them. | | | | planned changes. The company must review and |
| Medical device companies for instance must test and | | | | approve them before and after they're made, and all |
| approve proposed changes before change can be | | | | proposed changes should be tested and approved |
| implemented and when changes are implemented | | | | before they are implemented in manufacturing - even |
| their status records and process results must be | | | | one-time changes. Moreover, manufacturers must |
| tracked and analyzed closely. For medical device | | | | have an approved rework procedure in place before |
| companies these requirements apply equally to | | | | they can reprocess product for clinical trials or |
| investigational devices. | | | | commercial sale." |
| Proposed Changes in Various Areas of Compliance | | | | The rework procedures mentioned in the FDA article |
| The control of proposed changes is not only | | | | are an essential companion to planned changes as |
| necessary in manufacturing environments but is also a | | | | they provide a pillow to any unexpected mishaps. |
| factor during GLP regulated studies and clinical | | | | Contractors and Planned/Implemented Changes |
| research trials. Companies are right in assuming | | | | Changes that have been undertaken by contractors |
| however that stakes are still high in manufacturing | | | | to a medical device manufacturer for example must |
| departments. In fact, a recent FDA article Change | | | | be reported to a representative(s) of the |
| Control: Best Practices for FDA-Compliant Medical | | | | manufacturing company. The procedures acted upon |
| Device Manufacturers states that "Manufacturers | | | | to report these changes must of course be |
| have to control changes in all of the major areas in | | | | documented by the manufacturing entity that initially |
| which they operate or function, including processes, | | | | hired the contractor organization. |
| product formulation and design, raw materials, | | | | Conclusion |
| equipment, facilities, utilities, computer systems, batch | | | | It may be helpful for life science companies to think |
| records, SOPs, analytical test methods, work | | | | of change control as the management of |
| instructions, master device records, specifications and | | | | unexpected change across company departments |
| policies." | | | | and across various levels of compliance but instead |
| What departments will take responsibility for | | | | as three types of change that must be continually |
| proposed changes? | | | | managed within the same dimensions. |
| Depending on the company, a variety of | | | | |