Here are the major requirements.

• Leadership
• Production Team Taking Ownership of the Rules
• Quality Assurance Team enforcing the Regulatory Code
• Ongoing cGMP training

The leader is responsible for driving the process, and it falls under the responsibility of the QA/QC team. It can often be a challenge to get the production team members on board, and taking ownership can also be difficult. Taking ownership means that the production team members are fully motivated to perform the duties and tasks that are at the core of CGMP. It takes time and training to ensure that the members are thoroughly familiar with the quality management system.

All employees should be trained in the team concept of CGMP. It is crucial for all members of the organization to understand the significant benefits of instilling the necessary discipline to achieve a global CGMP third-party certification.

The overriding goal of a quality management program is to meet all of the requirements of the product specification. The Product Specification states following:

Every Product must have a written Product Specification including:

• Raw materials used ( Supplier approved)
• All packaging components (containers, dessicants, cotton, lids, etc. ) (Supplier Approved)
• All laboratory tests: quantitative and qualitative  (Supplier Approved)
• Labeling specifications

Writing this article is the easy part. The hard issue is maintaining consistent discipline in operations to meet the goal in every production cycle.

“I specialize in creating compliant, high-quality cGMP Document Management Systems at an affordable price for small manufacturers and processors who may believe they cannot afford it.

If this sounds like you, feel free to give me a call or send me an email. I am dedicated to helping you bring your business into compliance.”