In the course of globalisation, the chemical industry is increasingly gaining importance as a major supplier of excipients and active ingredients as well as the corresponding intermediate products. Many of these raw materials, which are important for pharmaceutical product manufacturing, are mainly produced in chemical plants in China and India, but also still in Europe and the USA.
From a regulatory perspective, the production of active ingredients is subject among other things to the requirements of the ICH Q7 GMP guideline that originated in the 1990s and is today’s GMP bible for the chemicals industry. Excipients – extensively discussed and with a significant influence on the quality of end products – on the other hand still have to make do with industrial guidelines such as the IPEC GMP Guide. The chemicals sector itself does not permit the excesses of high gloss and lots of paper – economic efficiency is required!
That makes the lives of those who want to achieve GMP compliance a balancing act. Nowhere is the question of mandatory versus optional more crucial than in this industry sector.
gempex specialises in adapting GMP to customer requirements with a sense of proportion. Not too much, but the essentials to ensure product quality and compliance. And taking into account the cost-effectiveness of these products.
This is where GMP compliance consultancy based on practical experience provides protection. Pragmatic concepts – from plant qualification to IT validation – are easy on budgets that are often stretched already. Permanently outsourcing SOP maintenance can be a solution when internal personnel resources are lacking. However, a GAP analysis conducted by experts certainly plays a leading role. Especially in the chemicals sector, it is an absolute must to avoid being misled by high pharmaceutical standards. And in Asia, 3rd-party audits are an essential component of quality assurance.
gempex is a proven expert in all GMP matters for the chemicals industry and its suppliers.
Select Service Examples*
- Multi-Product Facility for Manufacturing Chemical Active Ingredients
GMP consultancy, concept implementation, GMP concept for utilities, planning support, implementation support with qualification and validation
- Capacity Expansion and Modernisation of Pharmaceutical Excipients Production
GMP consultancy, GMP implementation with the components of qualification and validation
- New Construction of Spray Drying and Conversion of Filling Lines, Capacity Expansion for Active Substances
Concept consultancy, GMP requirements specification, prospective qualification
- Excipients and Active Ingredients Production
Comprehensive GMP upgrade: GMP consultancy, risk analyses, GMP requirements specification, qualification (DQ, IQ, OQ, PQ), validation, training
- Expansion of an Existing Facility and Selective New Construction for Manufacturing Solid Active Ingredients
Implementation of GMP for active ingredients production with qualification, validation and MES validation
* Since we highly value the trust and confidentiality of our customers, we purposefully refrain from disclosing our customers in general. We will gladly provide you with specific references on request.