What are the differences between quality certification in the chemical industry and biopharmaceuticals?
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I used to work in a pharmaceutical company, where the quality certifications I was involved in complied with GMP standards. Now, chemical manufacturing enterprises need to obtain quality certification. Friends who are experienced in this field, could you please point out what the differences are in their specific methods, and what distinctions exist in the details of the certification?
Mainly, it’s because the standards followed are different, and the specific approaches vary, though the underlying concept remains similar.
Look for an ISO 9001 one
GMP certification has higher requirements for hardware. Chemical companies generally pursue integrated certification for the ISO9000\14000\18000 systems. It’s mainly about the requirements for documents and records.
The GMP certification requirements are all the same
GMP requirements are stricter, with more aspects and contents that need to be audited