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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
an approved label copy
approved supplier and manufacturer (if available)
sampling instruction or reference
storage conditions
any precautions
Finished products
Specifications for products typically include:
an exact statement of the active material
the product code (if any)
the dosage form and/or strength
physical appearance and identity
all tests and their limits
details of, or reference to, the test methods
sampling instructions
the shelf life and storage conditions
designated name
package details
formula (or reference to a formula)
any precautions
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