Since the topic of change management is so complex, each pharmaceutical company has created its own process to address change management.
If there is something that characterizes the pharmaceutical manufacturing environment today it is change. Whether it is because of a new product, a new delivery method, a merger, new materials, or new equipment, pharmaceutical companies must be ready to learn new ways of doing things.
Some companies do not keep records of the number of document control or quality assurance changes they perform, which may range from 30 to 160 a month, depending on the size and type of company. For compliance this randomness culture must be managed in order to be controlled.
Management of Change (MOC) programs aim to develop a process that is time, effort and financially efficient. The first step is to set a basic requirement and strategy, however, numerous QA managers in pharmaceutical companies do not adequately understand MOC or quality control, which results in firefighting and crisis management.
The FDA has still to issue a document directing companies on change management, but, in the meantime, the U.S. Occupational Health and Safety Administration (OSHA) provides a good model on how to manage it.
Among the MOC model, OSHA regulation 29 CFR 1910.119, Process Safety Management requirements are:
- Establishing written procedures and documentation for all changes
- Documenting the purpose of each change
- Reviewing each change for impact on safety, health, and environment
- Authorizing the implementation of the change
- Reviewing additional risks introduced into the process
- Setting a timetable for when temporary changes are to be removed or reevaluated
- Updating process safety information
- Revising or developing new operator and maintenance procedures as necessary
- Training employees and contractors who are affected by the change
- Maintaining the configuration of the plant
Clearly, change management is the basis of cGMPs. It works as the control function which acts as interface between the document control system and the management system. It intends to deliver information to create a timely response.
Effective MOC procedures and change control systems keep compliance and improve delivery time. For this to be so, documentation and communication must go hand in hand with the changes, the training must meet function changes, procedures have to be updated according to the changes, and safety practices and health standards should be reviewed for impact.
The data is collected from the plant’s operation sources, analyzed by a MOC committee and changed into information that can be implemented by management. Configuration management is intrinsic to MOC. It defines how the make-up of the facility, equipment, and process is managed. It is composed of 4 elements: Identification, control, status accounting, and verification.
To ensure continuous improvement, the process, equipment, procedures, technology, material, and organization must change and the MOC system permanently improved. The basic steps to achieve this are:
- Documentation review
- Change proposal
- Change classification
- Implementation plan
Before taking these steps, make sure that the system design is taken care of. Identify the needed change and review the standard documentation.
Change management is a science in itself, one that may translate into more profits and less waste, so, ask a pharmaceutical consultant about it and learn the best practices to act upon today.