In 1955 more than 200,000 children in the US received a defective Polio vaccine. The manufacturing process to inactivate the live virus proved ineffective. The consequences were horrible. Naturally authorities worldwide (such as EU, EMA and FDA) wanted to prevent grave incidents like these. That’s why they started developing a continuously expanding body of ever more complex legislation. To help companies comply with these rules and regulations Good Manufacturing Practices (GMP) were developed.
GMP is about quality and avoiding risks
GMP offers practical guidelines (like the Annex 1 draft) to comply with the local and international laws and directives. The guidelines apply to all aspects of manufacturing and span the entire production cycle: from raw materials to the quality control of the final product. Major GMP issues are:
- document management: both comprehensive and thorough;
- verifying the accuracy of processes;
- rules of conduct in the production environment;
- validation practices for processes and equipment;
- how to correct mistakes.
Data integrity: a key topic for GMP
In the production of pharmaceuticals data integrity is an important issue. That’s why it is an essential part of GMP. The guidelines cover data integrity topics such as audit trail, serialisation, unique login procedures and logs. Auditors will check these requirements. Problems may arise with old Quality Management Systems and hardware. Luckily new equipment is often compliant.
GMP involves all manufacturing partners
All players in the production cycle need to master GMP. This includes manufacturers of pharmaceuticals, production plants for APIs, laboratories… Most producers have already embedded GMP in their company culture. But some external production partners, warehouses for instance, find it difficult to become fully compliant.
Bringing external partners up to GMP speed
Third parties, especially smaller external partners, are less experienced in GMP. Moreover, complying with the complex legislation is costly and time-consuming.
That’s why the bigger players audit their suppliers. Their demands and criteria tend to become more rigorous. This additional control assures that all rules will be respected. GMP guidelines provide support to streamline this process.
Integrating local and global legislation
Life science companies need to comply with the legislation of the countries they export to. Nowadays ICH is developing international standards that are universally valid. There’s a trend towards closer international alignment of legislation.
GMP guidelines keep evolving
GMP legislation tends to grow stricter and more global. The most import trend is risk-based approach. Potential dangers need to be identified, assessed and prevented. Automatic control of the entire process will allow limiting comprehensive checks. Stricter rules often require considerable adjustments in production and equipment. It is important not to get lost in the details and to focus on the essentials. Meanwhile making new regulations takes many years.
Discover QbD’s services for GMP
With ample experience in Quality Management for the pharmaceutical industry, QbD has the expertise to make GMP work for you. We’ll gladly assist you in your GMP compliancy. Are you looking for GMP training? Our one-day workshop gives you an overview of all crucial GMP aspects.
More information on the new EU GMP legislation?
Read here about the Annex 1 draft.