Good manufacturing practice (GMP) is a system designed to ensure that products are consistently manufactured and controlled according to quality standards. It has been developed to minimise the risks associated with any pharmaceutical production and which cannot be avoided by testing the product.
There is not only one GMP
The version of the GMP of the World Health Organization (WHO) is used by regulatory authorities and industry in over a hundred countries worldwide. The European Union GMP (EU GMP) implements similar requirements to the WHO GMP, as does the FDA's version in the USA.
GMP defines national and international rules for the 'good manufacturing practice of pharmaceuticals', defining requirements for the following areas:
- Hygiene
- Manufacturing processes
- Premises
- Equipment
- Documentations
- Controls
- Error handling
For medicine, pharmacy and pharmaceutical chemistry, the rules were broken down into individual areas. The GMP term was expanded with the following terms, among others:
- Good Automated Manufacturing Practice (GAMP)
- Good Clinical Practice (GCP)
- Good Distribution Practice (GDP)
- Good Laboratory Practice (GLP)
- Good Manufacturing Practice (GMP)
- Good documentation practice
Not one hundred percent instruction
GMP guidelines are not instructions on how the production of pharmaceuticals should proceed. Rather, they are general principles that must be followed in manufacturing. There can be many ways for a company to define its quality programme and manufacturing process to meet GMP requirements. It is the responsibility of the company to choose the quality process that is effective and efficient. This quality should be reflected in the product. GMP is the most essential factor to ensure this product quality.
Qualification and validation
Companies are therefore qualified and validated to implement and comply with the rules. Qualification in this context is the proof that a particular device, installation or system is suitable for its intended use.
the Validation on the other hand, refers to processes and procedures. The purpose of validation is to demonstrate that the processes, methods, tests, activities and equipment used are capable of producing a product repeatedly.
ERP ? Software essential for GMP implementation
Of course, the business software used, such as an ERP system, has a great influence on the feasibility of the guidelines. It is therefore a question of using software that can be validated. Whether an ERP software, for example, fulfils this requirement cannot necessarily be answered by whether it has been validated before.
Pharmaceutical manufacturing companies should evaluate the following critical requirements for a pharmaceutical ERP solution:
- Customer Relationship Management (CRM)
- Quotation and cost estimate
- Order processing and Available-to-Promise (ATP)
- Recipe management
- Laboratory Information Management System (LIMS)
- Document management
- Technical change management
- Forecasting and demand planning
- project billing (R&D)
- production
- Supply chain management software
- Advanced production planning
- Quality management
- Supplier management
- Serial number tracking
- Batch numbers-Tracking
- Traceability and recall management
- Warehouse Management Software (WMS)
- cost accounting
- Revenue recognition
- Sales cost recording and management
Purchasing documents in SAP Business One - consistently efficient
Outline agreements in SAP Business One
GMP standards for ERP in the pharmaceutical industry
ERP solutions for make-to-order production
When does an ERP system have to adapt?
