For pharmaceutical and other life science disciplines, the ‘5Ps of GMP’ are a useful way of thinking about the key compliance areas which ensure the quality, consistency and safety of your end products.GMP, also known as cGMP (Current Good Manufacturing Practice) ensures pharmaceutical products, medical devices and other regulated items are consistently manufactured and controlled according to quality standards - thus reducing the risk of harm to consumers.
In pharmaceutical manufacturing, the need for repeatable precision is everything. The uniformity of approach and procedure in making drugs is key to ensuring users can be confident that their medicines contain the right ingredients and in the right quantity to have the desired effect. There must be complete confidence that no deviation, adulteration or contamination has taken place at any stage of manufacture.
We’re often told that quality can’t be ‘tested into’ medicines retrospectively. Instead the only way quality and consistency can be guaranteed in the large scale production of drugs is through the meticulous application of standardised procedures by fully trained and accountable workers.
By focusing on the 5Ps and applying the required controls to their operations, manufacturers can be confident that they are compliant and able to demonstrate their compliance to inspectors and certifying bodies when necessary
What are the 5Ps of GMP?
Everyone involved in making a drug must have clear roles and responsibilities. Employees must be trained to follow procedure and their performances must be assessed. Training methods must be periodically reviewed so that manufacturers know they remain effective in keeping workers properly trained and competent.
PROCESSES and PROCEDURES
A process is a series of related tasks that together turn inputs into outputs. A procedure is a prescribed way of undertaking a process or part of a process to achieve a consistent end result. Both processes and procedures must be defined and documented to give complete clarity around what a business needs to achieve and how they need to meet the required standards in their operations. All procedures must be laid out clearly and followed. If there is any deviation from standard procedure, it needs to be investigated and reported. Routinely recording data at key stages of manufacture will mean that if there is a problem with a batch and it needs to be recalled, finding the source of any issue or non-conformance in quality will be much easier.
PREMISES (including equipment)
The facility must have clearly documented cleaning procedures for all their premises and equipment. There must be measures in place to prevent cross-contamination. There must be documented instructions for calibrating equipment. The design of a facility must take these requirements into account and equipment must be continuously validated and calibrated to ensure they are fit for purposes and producing consistent results.
All of these ‘Ps’ are intended to support the quality and consistency of the end products that will be used by consumers. And it’s an end to end responsibility, ensuring goods that come into and leave the facility are in good order and handled appropriately. For example, manufacturers must have specifications for all the raw materials and components they use. Overall, they must have repeatable methods for research, development, processing, manufacture and packaging, testing, sampling, status control, stability testing and record keeping.
Digital Quality Management Systems are ultimately the means by which every aspect of the 5Ps are defined and controlled across an organisation and its workforce.
- Standard operating procedures are defined and well-documented.
- Manufacturing processes are defined and controlled (and any changes to processes are evaluated and validated)
- The manufacturing process is recorded to prove that all required procedures and instructions are properly followed.
- Manufacturing occurs in a controlled environment that prevents cross-contamination.
- The causes of any quality defects are investigated and action taken to ensure that the defect does not occur again.
The sophistication and usability of digital tools you use will affect your ability to ensure controlling the 5Ps of GMP are a fundamental part of 'the way you do things'.