Good Manufacturing Practice (GMP) Guidelines

Let MasterControl Help to Assure your System Complies to the Requirements for Good Manufacturing Practice (GMP) Guidelines

The process of complying with the requirements of good manufacturing practice guidelines is considered by many FDA-regulated companies to be a time consuming and expensive ordeal. In fact, the opposite is true: not complying with GMP guidelines can be a time consuming and expensive ordeal.

The FDA's current regulations for good manufacturing practice guidelines are there to ensure that products are consistently produced in a controlled environment with quality standards guiding their intended use. For well over a decade, MasterControl has led the quality management software industry in providing the products, training, and support that companies need to attain and sustain compliance.

Watch Videos How MasterControl Makes Your Job Easier (3:50) Using MasterControl for FDA Compliance (3:53)

The MasterControl Suite Ensures Compliance with Good Manufacturing Practice Guidelines

The MasterControl Suite offers the following integrated applications (to name but a few):

• MasterControl Documents automates the entire lifecycle of all documents-based processes, including task assignment/routing, follow-up, tracking, escalation, review, and approval.
• MasterControl Training automates assignment and monitoring of training tasks and grading of online exams to assure compliance with GMP guidelines. The software allows sequencing of training courses, so that after a prerequisite course is completed, the next course is automatically launched. The software also provides a group sign-off feature for verifying the training of large groups of employees. Training management can be integrated with the rest of the quality system to ensure implementation of good manufacturing practice guidelines, so that any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.
• MasterControl CAPA connects with different quality subsystems to track incidents, following from problem identification through corrective action. A CAPA can automatically be launched from another form, allowing users to enter relevant data into the CAPA form itself.
• MasterControl Change Control streamlines the change control process for faster turnaround. It offers a best practice form that incorporates current requirements for GCP, GLP, and GMP guidelines.
• MasterControl Nonconformance is designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of any nonconforming materials and finished products to ensure compliance with good manufacturing practice (GMP) guidelines guidelines.

cGxP GMP Challenges

A laboratory's ultimate goal is to ensure the accuracy and quality of tests. To achieve this goal, the lab must address many challenges, including:

• Inefficient Quality System: Labs with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems according to good manufacturing practice guidelines, especially paper-based or hybrid systems. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during inspections.
• Disconnected Processes: Quality processes that are not connected to each other can cause delays and poor results. For example, a change control process that's not connected to customer complaint, CAPA, training, and other quality processes is likely to cause delays in change implementation.
• High Cost of Validation: 21 CFR Part 11 requires computer system validation as a way of ensuring the integrity of electronic records and signatures. Even if a lab successfully automates its manual record-keeping system, it still faces the daunting work and the high cost of validation. Labor-intensive validation tests conducted by internal staff and exorbitant consultant fees can easily double a company's compliance cost with respect to good manufacturing practice guidelines.

For More Information on Good Manufacturing Practice (GMP) Guidelines

For more information about GMP guidelines and how our software can help your company meet current good manufacturing practices, please feel free to contact a MasterControl representative.