Page 48 - Introduction QC
P. 48
GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
Specifications for packaging materials should
include:
a detailed description of the item
inspections and/or tests required
acceptance criteria
an approved label copy
approved supplier and manufacturer (if
available)
sampling instruction or reference
storage conditions
any precautions
Finished Materials:
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)
Copyright©www.gmpsop.com. All rights reserved
Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited.
Page 48 of 52
