Page 29 - Documentation and Records
P. 29
GMP Training – Documentation and Records by www.gmpsop.com
Summary
A good documentation system is the cornerstone of a GMP compliance
system.
All personnel must follow the written and approved documents in the day-to-
day operation of the manufacturing facility.
It is the responsibility of management to provide a documentation system that
conforms to the GMP requirements, and then train the users in the
requirements of the system.
It is your responsibility to understand the documents and use them correctly.
When you sign or initial a record saying that you carried out a process, you
are certifying that the process was carried out according to the written and
approved procedures.
When you sign or initial a checking step in a record, you are saying that you
observed what was done, and can verify that it was done correctly.
It is only by having a documentation system that everyone complies with, that
we can demonstrate that we have manufactured a quality product.
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